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Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cetuximab
cisplatin
paclitaxel
radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage IIA esophageal cancer, stage IIB esophageal cancer, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer, stage IV esophageal cancer, squamous cell carcinoma of the esophagus

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pathologically (histologic or cytologic) proven diagnosis of primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 12 weeks prior to registration. Patients with involvement of the gastroesophageal junction with Siewert type I or II tumors (tumors arising from the distal esophagus and involving the esophagogastric junction or tumors starting at the esophagogastric junction and involving the cardia) are eligible.

    • 1.1 Disease must be encompassed in a radiotherapy field.
    • 1.2 Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible.
    • 1.3 Patients with cervical esophageal carcinoma are eligible.

  2. Stage T1N1M0; T2-4, Any N, M0; Any T, Any N, M1a, based upon the following minimum diagnostic work-up:

    • 2.1 History/physical examination within 6 weeks prior to registration
    • 2.2 Positron emission tomography (PET)/positron emission tomography-computed tomography (PET-CT) scan (strongly recommended) or chest/abdominal CT within 6 weeks prior to registration
    • 2.3 Electrocardiogram (EKG) within 6 weeks of study entry
    • 2.4 Endoscopy with biopsy or cytology by fine needle aspiration (FNA) (must be able to document histologic subtype) within 12 weeks of study entry. Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to exclude fistula. (NOTE: Any images from endoscopic procedures up to the time of progression must be kept in the patient's confidential study file.)
  3. Zubrod performance status 0-2
  4. Age ≥ 18 and ≤ 74 (upper limit was set at 74 in an amendment)

  5. Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:

    • 5.1 Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
    • 5.2 Platelets ≥ 100,000 cells/mm3
    • 5.3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥8.0 g/dl is acceptable.)

  6. Additional laboratory studies obtained within 2 weeks prior to registration on study

    • 6.1 Creatinine ≤ 1.5 mg/dl
    • 6.2 Bilirubin ≤ 1.5 x upper limit of normal
    • 6.3 Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
    • 6.4 Serum pregnancy test for women of childbearing potential
  7. Patient's total intake (oral/enteral) must be ≥ 1500 kCal/day
  8. Patient must provide study-specific informed consent prior to study entry
  9. Women of childbearing potential and male participants must practice adequate contraception

Exclusion Criteria:

  1. Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to exclude fistula.
  2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  3. Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable.
  4. Prior radiation therapy that would result in overlap of planned radiation therapy fields.
  5. Prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway.
  6. Prior platinum-based and/or paclitaxel-based therapy.
  7. Prior allergic reaction to the study drugs involved in this protocol.
  8. Prior severe infusion reaction to a monoclonal antibody.

  9. Severe, active comorbidity, defined as follows:

    • 9.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months
    • 9.2 Transmural myocardial infarction within the last 6 months
    • 9.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • 9.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    • 9.5 Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients.
  10. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
  11. Women who are nursing.

Sites / Locations

  • Arizona Oncology - Tucson
  • Auburn Radiation Oncology
  • Radiation Oncology Centers - Cameron Park
  • Mercy Cancer Center at Mercy San Juan Medical Center
  • Enloe Cancer Center at Enloe Medical Center
  • California Cancer Center - Woodward Park Office
  • Saint Agnes Cancer Center at Saint Agnes Medical Center
  • Memorial Medical Center
  • Radiation Oncology Center - Roseville
  • Radiological Associates of Sacramento Medical Group, Incorporated
  • University of California Davis Cancer Center
  • Mercy General Hospital
  • Solano Radiation Oncology Center
  • Sutter Solano Medical Center
  • Rocky Mountain Cancer Centers - Aurora
  • Porter Adventist Hospital
  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
  • William W. Backus Hospital
  • CCOP - Christiana Care Health Services
  • University of Florida Shands Cancer Center
  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  • Center for Cancer Care and Research at Watson Clinic, LLP
  • CCOP - Mount Sinai Medical Center
  • Baptist-South Miami Regional Cancer Program
  • M.D. Anderson Cancer Center at Orlando
  • John B. Amos Cancer Center
  • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
  • Cancer Research Center of Hawaii
  • Queen's Cancer Institute at Queen's Medical Center
  • Hawaii Medical Center - East
  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • University of Chicago Cancer Research Center
  • Cardinal Bernardin Cancer Center at Loyola University Medical Center
  • Advocate Lutheran General Cancer Care Center
  • Swedish-American Regional Cancer Center
  • Cancer Institute at St. John's Hospital
  • Saint John's Cancer Center at Saint John's Medical Center
  • Bloomington Hospital Regional Cancer Institute
  • Radiation Oncology Associates Southwest
  • Parkview Regional Cancer Center at Parkview Health
  • Methodist Cancer Center at Methodist Hospital
  • Central Indiana Cancer Centers - East
  • Cancer Center at Ball Memorial Hospital
  • Memorial Hospital of South Bend
  • McFarland Clinic, PC
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
  • Mercy Cancer Center at Mercy Medical Center - Des Moines
  • Mercy Cancer Center at Mercy Medical Center - North Iowa
  • Siouxland Hematology-Oncology Associates, LLP
  • James Graham Brown Cancer Center at University of Louisville
  • Mary Bird Perkins Cancer Center - Baton Rouge
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Greater Baltimore Medical Center Cancer Center
  • St. Agnes Hospital Cancer Center
  • Hudner Oncology Center at Saint Anne's Hospital - Fall River
  • Saint Joseph Mercy Cancer Center
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Genesys Hurley Cancer Institute
  • Lacks Cancer Center at Saint Mary's Health Care
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • West Michigan Cancer Center
  • St. Mary Mercy Hospital
  • Mercy Regional Cancer Center at Mercy Hospital
  • Seton Cancer Institute at Saint Mary's - Saginaw
  • MeritCare Bemidji
  • Mercy and Unity Cancer Center at Mercy Hospital
  • Minnesota Oncology - Maplewood
  • Regions Hospital Cancer Care Center
  • United Hospital
  • University of Mississippi Cancer Clinic
  • Cancer Institute of Cape Girardeau, LLC
  • Saint Louis University Cancer Center
  • Missouri Baptist Cancer Center
  • David C. Pratt Cancer Center at St. John's Mercy
  • Billings Clinic - Downtown
  • Sletten Cancer Institute at Benefis Healthcare
  • Methodist Estabrook Cancer Center
  • Lakeside Hospital
  • CCOP - Nevada Cancer Research Foundation
  • Payson Center for Cancer Care at Concord Hospital
  • Seacoast Cancer Center at Wentworth - Douglass Hospital
  • Center for Cancer Care at Exeter Hospital
  • Kingsbury Center for Cancer Care at Cheshire Medical Center
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Elliot Regional Cancer Center at Elliot Hospital
  • Monmouth Medical Center
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  • Frederick R. and Betty M. Smith Cancer Treatment Center
  • J. Phillip Citta Regional Cancer Center at Community Medical Center
  • Cancer Institute of New Jersey at Cooper - Voorhees
  • New York Oncology Hematology, PC at Albany Regional Cancer Care
  • Lourdes Regional Cancer Center
  • Charles R. Wood Cancer Center at Glens Falls Hospital
  • Beth Israel Medical Center - Petrie Division
  • St. Luke's - Roosevelt Hospital Center - St.Luke's Division
  • Memorial Sloan-Kettering Cancer Center
  • Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
  • Mission Hospitals - Memorial Campus
  • Alamance Cancer Center at Alamance Regional Medical Center
  • Presbyterian Cancer Center at Presbyterian Hospital
  • Kinston Medical Specialists
  • CCOP - MeritCare Hospital
  • McDowell Cancer Center at Akron General Medical Center
  • Summa Center for Cancer Care at Akron City Hospital
  • Barberton Citizens Hospital
  • Mercy Cancer Center at Mercy Medical Center
  • Aultman Cancer Center at Aultman Hospital
  • Case Comprehensive Cancer Center
  • MetroHealth Cancer Care Center at MetroHealth Medical Center
  • Lake/University Ireland Cancer Center
  • Southwest General Health Center
  • UHHS Chagrin Highlands Medical Center
  • Robinson Radiation Oncology
  • UHHS Westlake Medical Center
  • Oklahoma University Cancer Institute
  • Natalie Warren Bryant Cancer Center at St. Francis Hospital
  • Clackamas Radiation Oncology Center
  • Willamette Valley Cancer Center - Eugene
  • Providence Cancer Center at Providence Portland Medical Center
  • Providence St. Vincent Medical Center
  • UPMC Cancer Center at Beaver Medical Center
  • UPMC Cancer Center at Jefferson Regional Medical Center
  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital
  • Regional Cancer Center - Erie
  • Adams Cancer Center
  • UPMC Cancer Center - Arnold Palmer Pavilion
  • Frankford Hospital Cancer Center - Torresdale Campus
  • Albert Einstein Cancer Center
  • UPMC - Shadyside
  • UPMC Cancer Center at UPMC St. Margaret
  • UPMC Cancer Center at UPMC Passavant
  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
  • UPMC Cancer Center at UPMC Northwest
  • York Cancer Center at Apple Hill Medical Center
  • Rhode Island Hospital Comprehensive Cancer Center
  • Northmain Radiation Oncology
  • Hollings Cancer Center at Medical University of South Carolina
  • Cancer Centers of the Carolinas - Faris Road
  • CCOP - Greenville
  • Cancer Centers of the Carolinas - Seneca
  • CCOP - Upstate Carolina
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  • Cancer Centers of the Carolinas - Spartanburg
  • Rapid City Regional Hospital
  • Sanford Cancer Center at Sanford USD Medical Center
  • Thompson Cancer Survival Center
  • Harrington Cancer Center
  • Texas Oncology, PA at Harris Center HEB
  • Texas Oncology, PA at Texas Cancer Center - Denton South
  • Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
  • Memorial Hermann Hospital - Memorial City
  • Longview Cancer Center
  • Joe Arrington Cancer Research and Treatment Center
  • Cancer Care Centers of South Texas - Northeast
  • Texas Oncology, PA at Texas Cancer Center - Sherman
  • Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
  • Tyler Cancer Center
  • Texas Oncology, PA - Wichita Falls
  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
  • Dixie Regional Medical Center - East Campus
  • Utah Cancer Specialists at UCS Cancer Center
  • Huntsman Cancer Institute at University of Utah
  • Northwest Cancer Specialists at Vancouver Cancer Center
  • Schiffler Cancer Center at Wheeling Hospital
  • St. Mary's Hospital Medical Center - Green Bay
  • St. Vincent Hospital Regional Cancer Center
  • Bay Area Cancer Care Center at Bay Area Medical Center
  • Veterans Affairs Medical Center - Milwaukee
  • Regional Cancer Center at Oconomowoc Memorial Hospital
  • Door County Cancer Center at Door County Memorial Hospital
  • Waukesha Memorial Hospital Regional Cancer Center
  • University of Wisconcin Cancer Center at Aspirus Wausau Hospital
  • Saint John Regional Hospital
  • McGill Cancer Centre at McGill University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chemoradiation + Cetuximab

Chemoradiation

Arm Description

External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab

External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin

Outcomes

Primary Outcome Measures

Overall Survival (24-month Rate Reported)
Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur after at least 281 deaths have been observed, unless an early stopping rule was satisfied.

Secondary Outcome Measures

Local Failure (24-month Rate Reported)
Local failure (LF) was defined as residual cancer on posttreatment biopsy findings or biopsy-proven recurrent primary disease and local failure time was measured from randomization to failure or last follow-up. Nonprotocol surgery to the primary site with gross residual disease was considered a LF as of the surgery date. Patients with no viable disease or microscopic residual disease at nonprotocol surgery were censored for LF as of the surgery date. Local failure was estimated by the cumulative incidence method with death considered a competing risk.
Percentage of Patients With Acute Grade 4 or 5 Non-hematologic Treatment-related Adverse Events
Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE
Endoscopic Complete Response Rate
All patients were to undergo a repeat endoscopy (EUS) 6-8 weeks after the completion of chemoradiation. At the time of EUS a visual inspection of the site of the original primary disease would be documented. Those patients found to be free of disease were NOT required to undergo repeat biopsy. These patients would be scored as clinical complete responses (cCR). Patients deemed to have residual disease or suspicion of residual disease would undergo a biopsy in order to pathologically confirm findings. Any patient with pathologically confirmed residual disease would be scored as a local failure. Patients who were pathologically proven to have no evidence of disease would be scored as cCRs.
Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment
The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score which ranges from 0-68. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-E including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicated better QOL. Improvement in FACT-E score is defined as an increase from baseline score of at least 5 points.
Quality-adjusted Survival (Using EQ-5D), Only if Primary Hypothesis is Supported

Full Information

First Posted
April 9, 2008
Last Updated
May 23, 2022
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00655876
Brief Title
Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer
Official Title
A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating esophageal cancer. PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.
Detailed Description
OBJECTIVES: Primary To evaluate whether the addition of cetuximab to chemotherapy comprising paclitaxel, cisplatin, and radiotherapy improves overall survival compared with paclitaxel, cisplatin, and radiotherapy alone in patients with esophageal cancer treated without surgery. Secondary To evaluate whether the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy improves local control by increasing the clinical complete response and decreasing local recurrence in these patients. To evaluate adverse events in these patients. To evaluate endoscopic complete response rates in these patients. To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy improves the Esophageal Cancer Subscale (ECS) score of the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) quality of life tool. To evaluate the quality-adjusted survival of each treatment arm using EQ-5D if the primary endpoint supports the primary hypothesis. OUTLINE: This is a multicenter study. Patients are stratified according to histology (adenocarcinoma vs squamous), cancer lesion size (< 5 cm vs ≥ 5 cm), and disease status of celiac nodes (present vs absent). Patients are randomized to 1 of 2 treatment arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
stage IIA esophageal cancer, stage IIB esophageal cancer, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer, stage IV esophageal cancer, squamous cell carcinoma of the esophagus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
344 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemoradiation + Cetuximab
Arm Type
Experimental
Arm Description
External beam radiation therapy (RT) with concurrent weekly paclitaxel, cisplatin, and cetuximab
Arm Title
Chemoradiation
Arm Type
Active Comparator
Arm Description
External beam radiation therapy with concurrent weekly paclitaxel, and cisplatin
Intervention Type
Drug
Intervention Name(s)
cetuximab
Intervention Description
Weekly with external beam radiation therapy for a total of six doses. The initial dose of cetuximab is 400 mg/m^2 intravenously administered over 120 minutes on day 1, followed by weekly infusions of 250 mg/m^2 intravenously over 60 minutes on days 8, 15, 22, 29, and 36. The infusion rate of cetuximab must never exceed 5 mL/min.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Weekly with external beam radiation therapy for a total of six doses. Patients receive 25 mg/m^2 as an intravenous infusion over 30-60 minutes on days 1, 8, 15, 22, 29 and 36.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
Weekly with external beam radiation therapy for a total of six doses. Patients receive 50 mg/m^2 as an intravenous infusion over 1 hour on days 1, 8, 15, 22, 29 and 36.
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
1.8 Gy daily for 28 days (over 5-6 weeks) for a total dose of 50.4 Gy.
Primary Outcome Measure Information:
Title
Overall Survival (24-month Rate Reported)
Description
Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur after at least 281 deaths have been observed, unless an early stopping rule was satisfied.
Time Frame
From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months.
Secondary Outcome Measure Information:
Title
Local Failure (24-month Rate Reported)
Description
Local failure (LF) was defined as residual cancer on posttreatment biopsy findings or biopsy-proven recurrent primary disease and local failure time was measured from randomization to failure or last follow-up. Nonprotocol surgery to the primary site with gross residual disease was considered a LF as of the surgery date. Patients with no viable disease or microscopic residual disease at nonprotocol surgery were censored for LF as of the surgery date. Local failure was estimated by the cumulative incidence method with death considered a competing risk.
Time Frame
From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months.
Title
Percentage of Patients With Acute Grade 4 or 5 Non-hematologic Treatment-related Adverse Events
Description
Adverse events (AE) are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE
Time Frame
From start of treatment to 90 days from end of treatment
Title
Endoscopic Complete Response Rate
Description
All patients were to undergo a repeat endoscopy (EUS) 6-8 weeks after the completion of chemoradiation. At the time of EUS a visual inspection of the site of the original primary disease would be documented. Those patients found to be free of disease were NOT required to undergo repeat biopsy. These patients would be scored as clinical complete responses (cCR). Patients deemed to have residual disease or suspicion of residual disease would undergo a biopsy in order to pathologically confirm findings. Any patient with pathologically confirmed residual disease would be scored as a local failure. Patients who were pathologically proven to have no evidence of disease would be scored as cCRs.
Time Frame
From randomization to 6-8 weeks after completion of chemoradiation (11-14 weeks)
Title
Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment
Description
The ECS is a 17-item self-report instrument designed to measure multidimensional quality of life in patients with esophagus cancer. It is to be administered with the Functional Assessment of Cancer Therapy - General (FACT-G). There are 5 responses options, with 0=Not a lot and 4=Very much. All items are added together to obtain a total score which ranges from 0-68. Certain items must be reversed before it is added by subtracting the response from 4. It requires at least 50% of the items to be completed while the overall response rate of the FACT-E including the FACT-G must be greater than 80%. If items are missing, the subscale scores can be prorated. A higher score indicated better QOL. Improvement in FACT-E score is defined as an increase from baseline score of at least 5 points.
Time Frame
Baseline, 6-8 weeks after completion of chemoradiation , 1 year and 2 years from treatment start.
Title
Quality-adjusted Survival (Using EQ-5D), Only if Primary Hypothesis is Supported
Time Frame
Baseline, 6-8 weeks after completion of chemoradiation, 1 year and 2 years from treatment start.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically (histologic or cytologic) proven diagnosis of primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 12 weeks prior to registration. Patients with involvement of the gastroesophageal junction with Siewert type I or II tumors (tumors arising from the distal esophagus and involving the esophagogastric junction or tumors starting at the esophagogastric junction and involving the cardia) are eligible. 1.1 Disease must be encompassed in a radiotherapy field. 1.2 Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible. 1.3 Patients with cervical esophageal carcinoma are eligible. Stage T1N1M0; T2-4, Any N, M0; Any T, Any N, M1a, based upon the following minimum diagnostic work-up: 2.1 History/physical examination within 6 weeks prior to registration 2.2 Positron emission tomography (PET)/positron emission tomography-computed tomography (PET-CT) scan (strongly recommended) or chest/abdominal CT within 6 weeks prior to registration 2.3 Electrocardiogram (EKG) within 6 weeks of study entry 2.4 Endoscopy with biopsy or cytology by fine needle aspiration (FNA) (must be able to document histologic subtype) within 12 weeks of study entry. Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to exclude fistula. (NOTE: Any images from endoscopic procedures up to the time of progression must be kept in the patient's confidential study file.) Zubrod performance status 0-2 Age ≥ 18 and ≤ 74 (upper limit was set at 74 in an amendment) Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows: 5.1 Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 5.2 Platelets ≥ 100,000 cells/mm3 5.3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥8.0 g/dl is acceptable.) Additional laboratory studies obtained within 2 weeks prior to registration on study 6.1 Creatinine ≤ 1.5 mg/dl 6.2 Bilirubin ≤ 1.5 x upper limit of normal 6.3 Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x upper limit of normal 6.4 Serum pregnancy test for women of childbearing potential Patient's total intake (oral/enteral) must be ≥ 1500 kCal/day Patient must provide study-specific informed consent prior to study entry Women of childbearing potential and male participants must practice adequate contraception Exclusion Criteria: Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. Patients with T3-4 proximal thoracic esophageal tumors (15-25 cm) must undergo bronchoscopy to exclude fistula. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). Prior systemic chemotherapy for esophageal cancer; note that prior chemotherapy for a different cancer is allowable. Prior radiation therapy that would result in overlap of planned radiation therapy fields. Prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway. Prior platinum-based and/or paclitaxel-based therapy. Prior allergic reaction to the study drugs involved in this protocol. Prior severe infusion reaction to a monoclonal antibody. Severe, active comorbidity, defined as follows: 9.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 9.2 Transmural myocardial infarction within the last 6 months 9.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 9.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 9.5 Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. Women who are nursing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohan Suntharalingam, MD
Organizational Affiliation
University of Maryland Greenebaum Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David H. Ilson, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Oncology - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Auburn Radiation Oncology
City
Auburn
State/Province
California
ZIP/Postal Code
95603
Country
United States
Facility Name
Radiation Oncology Centers - Cameron Park
City
Cameron Park
State/Province
California
ZIP/Postal Code
95682
Country
United States
Facility Name
Mercy Cancer Center at Mercy San Juan Medical Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Enloe Cancer Center at Enloe Medical Center
City
Chico
State/Province
California
ZIP/Postal Code
95926
Country
United States
Facility Name
California Cancer Center - Woodward Park Office
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Saint Agnes Cancer Center at Saint Agnes Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Memorial Medical Center
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
Facility Name
Radiation Oncology Center - Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Radiological Associates of Sacramento Medical Group, Incorporated
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Solano Radiation Oncology Center
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
Facility Name
Sutter Solano Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
William W. Backus Hospital
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0232
Country
United States
Facility Name
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Center for Cancer Care and Research at Watson Clinic, LLP
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Baptist-South Miami Regional Cancer Program
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
M.D. Anderson Cancer Center at Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
John B. Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Cancer Institute at Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Hawaii Medical Center - East
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Advocate Lutheran General Cancer Care Center
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068-1174
Country
United States
Facility Name
Swedish-American Regional Cancer Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61104-2315
Country
United States
Facility Name
Cancer Institute at St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Saint John's Cancer Center at Saint John's Medical Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
Bloomington Hospital Regional Cancer Institute
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Radiation Oncology Associates Southwest
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Parkview Regional Cancer Center at Parkview Health
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Methodist Cancer Center at Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Central Indiana Cancer Centers - East
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
Cancer Center at Ball Memorial Hospital
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303-3499
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
McFarland Clinic, PC
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center - North Iowa
City
Mason City
State/Province
Iowa
ZIP/Postal Code
50401
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
James Graham Brown Cancer Center at University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Mary Bird Perkins Cancer Center - Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Greater Baltimore Medical Center Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
St. Agnes Hospital Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Hudner Oncology Center at Saint Anne's Hospital - Fall River
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Saint Joseph Mercy Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Lacks Cancer Center at Saint Mary's Health Care
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
St. Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Hospital
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Seton Cancer Institute at Saint Mary's - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
MeritCare Bemidji
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
Mercy and Unity Cancer Center at Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Minnesota Oncology - Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Regions Hospital Cancer Care Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
University of Mississippi Cancer Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Cancer Institute of Cape Girardeau, LLC
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Saint Louis University Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Missouri Baptist Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
David C. Pratt Cancer Center at St. John's Mercy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Sletten Cancer Institute at Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Methodist Estabrook Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Lakeside Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Payson Center for Cancer Care at Concord Hospital
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
Seacoast Cancer Center at Wentworth - Douglass Hospital
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
Facility Name
Center for Cancer Care at Exeter Hospital
City
Exeter
State/Province
New Hampshire
ZIP/Postal Code
03833
Country
United States
Facility Name
Kingsbury Center for Cancer Care at Cheshire Medical Center
City
Keene
State/Province
New Hampshire
ZIP/Postal Code
03431
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Elliot Regional Cancer Center at Elliot Hospital
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03103
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740-6395
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Frederick R. and Betty M. Smith Cancer Treatment Center
City
Sparta
State/Province
New Jersey
ZIP/Postal Code
07871
Country
United States
Facility Name
J. Phillip Citta Regional Cancer Center at Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper - Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
New York Oncology Hematology, PC at Albany Regional Cancer Care
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Lourdes Regional Cancer Center
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Facility Name
Charles R. Wood Cancer Center at Glens Falls Hospital
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Facility Name
Beth Israel Medical Center - Petrie Division
City
New York
State/Province
New York
ZIP/Postal Code
10003-3803
Country
United States
Facility Name
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
City
Sleepy Hollow
State/Province
New York
ZIP/Postal Code
10591
Country
United States
Facility Name
Mission Hospitals - Memorial Campus
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Alamance Cancer Center at Alamance Regional Medical Center
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27216
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
Facility Name
Kinston Medical Specialists
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
CCOP - MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
McDowell Cancer Center at Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Summa Center for Cancer Care at Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309-2090
Country
United States
Facility Name
Barberton Citizens Hospital
City
Barberton
State/Province
Ohio
ZIP/Postal Code
44203
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Facility Name
Aultman Cancer Center at Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710-1799
Country
United States
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
MetroHealth Cancer Care Center at MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Lake/University Ireland Cancer Center
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Southwest General Health Center
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
UHHS Chagrin Highlands Medical Center
City
Orange Village
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Robinson Radiation Oncology
City
Ravenna
State/Province
Ohio
ZIP/Postal Code
44266
Country
United States
Facility Name
UHHS Westlake Medical Center
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Natalie Warren Bryant Cancer Center at St. Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Clackamas Radiation Oncology Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Willamette Valley Cancer Center - Eugene
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Providence Cancer Center at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2967
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
UPMC Cancer Center at Beaver Medical Center
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
UPMC Cancer Center at Jefferson Regional Medical Center
City
Clairton
State/Province
Pennsylvania
ZIP/Postal Code
15025
Country
United States
Facility Name
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Regional Cancer Center - Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Facility Name
Adams Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
UPMC Cancer Center - Arnold Palmer Pavilion
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
Frankford Hospital Cancer Center - Torresdale Campus
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
UPMC - Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2582
Country
United States
Facility Name
UPMC Cancer Center at UPMC St. Margaret
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Facility Name
UPMC Cancer Center at UPMC Passavant
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612-6052
Country
United States
Facility Name
UPMC Cancer Center at UPMC Northwest
City
Seneca
State/Province
Pennsylvania
ZIP/Postal Code
16346
Country
United States
Facility Name
York Cancer Center at Apple Hill Medical Center
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
Facility Name
Rhode Island Hospital Comprehensive Cancer Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Northmain Radiation Oncology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Cancer Centers of the Carolinas - Faris Road
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Cancer Centers of the Carolinas - Seneca
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Cancer Centers of the Carolinas - Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Sanford Cancer Center at Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Harrington Cancer Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Texas Oncology, PA at Harris Center HEB
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology, PA at Texas Cancer Center - Denton South
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Memorial Hermann Hospital - Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Longview Cancer Center
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410-1894
Country
United States
Facility Name
Cancer Care Centers of South Texas - Northeast
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Texas Oncology, PA at Texas Cancer Center - Sherman
City
Sherman
State/Province
Texas
ZIP/Postal Code
75090
Country
United States
Facility Name
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Texas Oncology, PA - Wichita Falls
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Dixie Regional Medical Center - East Campus
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Utah Cancer Specialists at UCS Cancer Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Northwest Cancer Specialists at Vancouver Cancer Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Schiffler Cancer Center at Wheeling Hospital
City
Wheeling
State/Province
West Virginia
ZIP/Postal Code
26003
Country
United States
Facility Name
St. Mary's Hospital Medical Center - Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3508
Country
United States
Facility Name
Bay Area Cancer Care Center at Bay Area Medical Center
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Veterans Affairs Medical Center - Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Regional Cancer Center at Oconomowoc Memorial Hospital
City
Oconomowoc
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Facility Name
Door County Cancer Center at Door County Memorial Hospital
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235-1495
Country
United States
Facility Name
Waukesha Memorial Hospital Regional Cancer Center
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
McGill Cancer Centre at McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28687830
Citation
Suntharalingam M, Winter K, Ilson D, Dicker AP, Kachnic L, Konski A, Chakravarthy AB, Anker CJ, Thakrar H, Horiba N, Dubey A, Greenberger JS, Raben A, Giguere J, Roof K, Videtic G, Pollock J, Safran H, Crane CH. Effect of the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation Therapy for Patients With Esophageal Cancer: The NRG Oncology RTOG 0436 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2017 Nov 1;3(11):1520-1528. doi: 10.1001/jamaoncol.2017.1598. Erratum In: JAMA Oncol. 2017 Nov 1;3(11):1589.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://nctn-data-archive.nci.nih.gov/
Available IPD/Information Identifier
NCT00655876
Available IPD/Information Comments
Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Learn more about this trial

Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer

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