Back to resultsCapecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
Primary Purpose
Esophageal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Induction Therapy - Capecitabine
Induction Therapy - Oxaliplatin
Combination Therapy - Capecitabine
Combination Therapy - Oxaliplatin
Combination Therapy - Radiation
Evaluation for response and surgery
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
- Stage I-IVA disease
- No distant metastatic disease (other than regional lymph nodes)
No evidence of CNS metastases
- CNS metastases stable for > 3 months allowed
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Consuming ≥ 1,500 calories daily
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No pre-existing neuropathy
- No prior unanticipated severe reaction to fluoropyrimidine therapy
- No known hypersensitivity to fluorouracil
- No known DPD deficiency
- No known hypersensitivity to any of the components of oxaliplatin
- No significant active infection or other severe complicated medical illness
- No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication)
- No myocardial infarction within the past 12 months
- No history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake
- No malabsorption syndrome
- No other active malignancy within the past 3 years except cervical carcinoma in situ or nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior participation in any investigational drug study
- No prior pelvic or thoracic radiotherapy
Sites / Locations
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Induction, Combination and surgery
Arm Description
Weeks 1-6: Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8 Weeks 7-12: Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday Evaluation for response and resection surgery
Outcomes
Primary Outcome Measures
Determine Pathologic Complete Response
Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections.
Pathologic response will be defined as:
P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer
Secondary Outcome Measures
Clinical Response Rate
Clinical response Rate will be expressed as the proportion of patients demonstrating a complete and/or partial response based on all evaluable patients treated.Clinical response will be evaluated according to Response Evaluation Criteria In Solid Tumors 1.0 (RECIST) .
Complete Response (CR) is defined as the disappearance of all target lesions Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,taking as reference the baseline sum LD
Recurrence Rate
Recurrence rate will be defined as disease recurrence, progressive disease or death. Patients will be followed for disease recurrence or death until the end of the study.
Time to Progression
Time to Progression will be measured as time from the first day of therapy until death, disease progression or last contact.
Patterns of Failure
Toxicity Profile
Toxicity will be assessed at the beginning of every cycle during chemotherapy for a total of 4 cycles (1 cycle =21 days) and then 30 days post last dose of chemotherapy. All toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE 3.0)
In general adverse events (AEs) will be graded according to the following:
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
Only incidents of AEs determined to be related to chemotherapy are recorded here.
Correlate Proteomic and Pharmacologic Characteristics With Prognosis and Response to Therapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00711412
Brief Title
Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
Official Title
A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 31, 2006 (Actual)
Primary Completion Date
May 29, 2009 (Actual)
Study Completion Date
January 30, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with esophageal or gastroesophageal junction cancer.
Detailed Description
OBJECTIVES:
Primary
Determine the pathologic complete response in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant therapy comprising capecitabine, oxaliplatin, and radiotherapy.
Secondary
Determine the clinical response rate in patients treated with this regimen.
Determine the recurrence rate, time to progression, and patterns of failure in patients treated with this regimen.
Characterize the toxicity profile of this regimen in these patients.
OUTLINE:
Induction therapy: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Combination chemoradiotherapy: Patients then receive oxaliplatin IV over 2 hours once weekly for 6 weeks. Patients also receive concurrent oral capecitabine twice daily and undergo radiotherapy once daily 5 days a week for 5½ weeks in the absence of disease progression or unacceptable toxicity.
Surgery: Patients undergo surgical resection at 4-8 weeks after completion of chemoradiotherapy.
After completion of study treatment, patients are followed every 3 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
adenocarcinoma of the esophagus, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Induction, Combination and surgery
Arm Type
Experimental
Arm Description
Weeks 1-6:
Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8
Weeks 7-12:
Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday
Evaluation for response and resection surgery
Intervention Type
Drug
Intervention Name(s)
Induction Therapy - Capecitabine
Intervention Description
Two 21-day cycles will be given as induction. Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off.
Intervention Type
Drug
Intervention Name(s)
Induction Therapy - Oxaliplatin
Intervention Description
Two 21-day cycles will be given as induction. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over two hours on days 1 and 8 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Combination Therapy - Capecitabine
Intervention Description
Two 21-day cycles will be given for combination therapy. Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks.
Intervention Type
Drug
Intervention Name(s)
Combination Therapy - Oxaliplatin
Intervention Description
Two 21-day cycles will be given. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle.
Intervention Type
Radiation
Intervention Name(s)
Combination Therapy - Radiation
Intervention Description
1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy.
Intervention Type
Procedure
Intervention Name(s)
Evaluation for response and surgery
Intervention Description
Four to eight weeks following the completion of therapy subjects will undergo evaluation for response and surgical resection.
Primary Outcome Measure Information:
Title
Determine Pathologic Complete Response
Description
Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections.
Pathologic response will be defined as:
P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer
Time Frame
At time of surgery
Secondary Outcome Measure Information:
Title
Clinical Response Rate
Description
Clinical response Rate will be expressed as the proportion of patients demonstrating a complete and/or partial response based on all evaluable patients treated.Clinical response will be evaluated according to Response Evaluation Criteria In Solid Tumors 1.0 (RECIST) .
Complete Response (CR) is defined as the disappearance of all target lesions Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,taking as reference the baseline sum LD
Time Frame
four to six weeks following completion of 4 cycles (1 cycle = 21days) of chemotherapy treatment and prior to surgery
Title
Recurrence Rate
Description
Recurrence rate will be defined as disease recurrence, progressive disease or death. Patients will be followed for disease recurrence or death until the end of the study.
Time Frame
From the time of start of treatment until first documentation of disease recurrence, progression or death, whichever comes first until the end of the study, a maximum of 6 years and 7 months.
Title
Time to Progression
Description
Time to Progression will be measured as time from the first day of therapy until death, disease progression or last contact.
Time Frame
From start of first treatment until time of first documentation of progression of disease or death, whichever comes first, until the study closes, up to a maximum of 6 years and 7 months.
Title
Patterns of Failure
Time Frame
At time of surgery
Title
Toxicity Profile
Description
Toxicity will be assessed at the beginning of every cycle during chemotherapy for a total of 4 cycles (1 cycle =21 days) and then 30 days post last dose of chemotherapy. All toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE 3.0)
In general adverse events (AEs) will be graded according to the following:
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
Only incidents of AEs determined to be related to chemotherapy are recorded here.
Time Frame
During chemotherapy treatment and up to 30 days post-last dose of chemotherapy.
Title
Correlate Proteomic and Pharmacologic Characteristics With Prognosis and Response to Therapy.
Time Frame
At time of sugery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
Stage I-IVA disease
No distant metastatic disease (other than regional lymph nodes)
No evidence of CNS metastases
CNS metastases stable for > 3 months allowed
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Consuming ≥ 1,500 calories daily
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
SGOT ≤ 2.5 times ULN
Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No pre-existing neuropathy
No prior unanticipated severe reaction to fluoropyrimidine therapy
No known hypersensitivity to fluorouracil
No known DPD deficiency
No known hypersensitivity to any of the components of oxaliplatin
No significant active infection or other severe complicated medical illness
No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication)
No myocardial infarction within the past 12 months
No history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake
No malabsorption syndrome
No other active malignancy within the past 3 years except cervical carcinoma in situ or nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior participation in any investigational drug study
No prior pelvic or thoracic radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Mulcahy, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Esophageal or Gastroesophageal Junction Cancer
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