Back to resultsChemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
fluorouracil
leucovorin calcium
paclitaxel
surgery
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N, M0) No metastatic cancer to the ovaries Age: 18 and over Easter Cooperative Oncology Group (ECOG) performance status 0-2 White blood cell (WBC) count at least 4,000 cells/mm3 Platelet count at least 150,000/mm3 Bilirubin less than 2 mg/dL Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 50 mL/min Caloric intake must be at least 1500 kcal/day No prior history of cancer within the past 5 years except for basal cell carcinoma of the skin or in situ carcinoma of the cervix No prior radiation therapy, except for skin cancer Fertile patients must use adequate contraception Met criteria for re-registration after surgery T1N1-2M0, T2N1-2M0 or T3-4NanyM0 at time of initial re-registration. No evidence of metastatic disease from postoperative pathologic staging. ECOG performance status of 0, 1, or 2 at re-registration Curative resection performed Re-registered 4 - 6 weeks from the date of surgery WBC ≥ 4000 cells/mm³, platelets ≥ 150,000/mm³, creatinine ≤ 1.5 mg/dl or creatinine clearance of > 50 ml/min (measured or calculated) and total serum bilirubin < 2 mg/dl, all within four weeks prior to re-registration Exclusion Criteria: Prior chemotherapy Clinically significant auditory impairment Significant heart disease Pregnant or lactating
Sites / Locations
- CCOP - Colorado Cancer Research Program, Inc.
- Emory University Hospital - Atlanta
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- Veterans Affairs Medical Center - Lakeside Chicago
- CCOP - Evanston
- CCOP - Carle Cancer Center
- Indiana University Cancer Center
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
- CCOP - Cedar Rapids Oncology Project
- CCOP - Ochsner
- New England Medical Center Hospital
- CCOP - Ann Arbor Regional
- CCOP - Kalamazoo
- CCOP - Metro-Minnesota
- CCOP - Missouri Valley Cancer Consortium
- Morristown Memorial Hospital
- Cancer Institute of New Jersey
- Raritan Bay Medical Center
- Somerset Medical Center
- Albert Einstein Comprehensive Cancer Center
- University of Rochester Cancer Center
- Ireland Cancer Center
- CCOP - Toledo Community Hospital Oncology Program
- University of Pennsylvania Cancer Center
- CCOP - MainLine Health
- Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
- Vanderbilt-Ingram Cancer Center
- CCOP - Marshfield Medical Research and Education Foundation
- Medical College of Wisconsin
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Arm
Arm Description
Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
Outcomes
Primary Outcome Measures
Grade 3 or Higher Toxicity Incidence on Step 1
Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients.
Secondary Outcome Measures
Best Confirmed Response to Neoadjuvant Therapy
Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable.
Overall Survival
Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive.
Progression Free Survival
Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation.
Full Information
NCT ID
NCT00003298
First Posted
November 1, 1999
Last Updated
June 21, 2023
Sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00003298
Brief Title
Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
Official Title
A Phase II Trial of Neoadjuvant Paclitaxel - Cisplatin Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 1999 (Actual)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells. E7296 was conducted to study neoadjuvant chemotherapy and postoperative chemoradiation therapy in patients diagnosed with high-risk gastric cancer using a new neoadjuvant regimen: paclitaxel plus cisplatin. It was hypothesized that this new neoadjuvant chemotherapy followed by surgery and chemoradiation therapy would be well tolerated and would have a high curative resection rate.
Detailed Description
OBJECTIVES:
Primary objective: To evaluate the tolerability and toxicity of neoadjuvant cisplatin plus paclitaxel and postoperative chemoradiation therapy with fluorouracil plus leucovorin calcium in patients with high-risk gastric cancer.
Secondary objectives: To assess the pathologic response of gastric tumors to neoadjuvant cisplatin plus paclitaxel chemotherapy, and preliminarily assess the patterns of failure and disease free and overall survival.
OUTLINE: Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment. Patients are followed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter.
PROJECTED ACCRUAL: Approximately 30-42 patients will be accrued over 18 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
Platinol, cis-platinum, cisdiamminedichloroplatinum (II), Platinol-AQ, DACP, platinum, CDDP, DDP
Intervention Description
Cisplatin was administered as part of the neoadjuvant regimen. It was given at a dose of 75 mg/m² via IV over approximately one hour, on day 1 of each cycle. Three cycles were given.
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Other Intervention Name(s)
5-Fluorouracil, 5-FU, Adrucil, Efudex
Intervention Description
Postoperative regimen 5-FU, along with Leucovorin, was given by IV bolus, with 5-FU given immediately after the Leucovorin
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Other Intervention Name(s)
Leucovorin, Wellcovorin, citrovorum factor, folinic acid, 5-formyl tetrahydrofolate, LV, LCV
Intervention Description
Both 5-FU and Leucovorin will be given via IV bolus, with Leucovorin given immediately before 5-FU.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Taxol®, NSC 125973
Intervention Description
Paclitaxel was administered as part of the neoadjuvant regimen. It was given at a dose of 175 mg/m² as a 3 hour continuous intravenous infusion on day 1. Three cycles were given.
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
The surgical procedure performed involved a radical subtotal or total gastrectomy.
A complete surgical resection was required
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
Concomitant chemotherapy and radiation therapy course: 5-FU 400 mg/m²/day + Leucovorin 20 mg/m²/day on days 1-4 of week one and days 1-3 of week 5 of XRT. Combined chemotherapy and radiation therapy were to begin 4 weeks after day 1 of the initial course of chemotherapy
Primary Outcome Measure Information:
Title
Grade 3 or Higher Toxicity Incidence on Step 1
Description
Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients.
Time Frame
assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)
Secondary Outcome Measure Information:
Title
Best Confirmed Response to Neoadjuvant Therapy
Description
Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable.
Time Frame
Assessed at surgery time (surgery performed during week 8-10 after registration to the study)
Title
Overall Survival
Description
Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive.
Time Frame
assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10
Title
Progression Free Survival
Description
Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation.
Time Frame
assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N, M0)
No metastatic cancer to the ovaries
Age: 18 and over
Easter Cooperative Oncology Group (ECOG) performance status 0-2
White blood cell (WBC) count at least 4,000 cells/mm3
Platelet count at least 150,000/mm3
Bilirubin less than 2 mg/dL
Creatinine no greater than 1.5 mg/dL
Creatinine clearance greater than 50 mL/min
Caloric intake must be at least 1500 kcal/day
No prior history of cancer within the past 5 years except for basal cell carcinoma of the skin or in situ carcinoma of the cervix
No prior radiation therapy, except for skin cancer
Fertile patients must use adequate contraception
Met criteria for re-registration after surgery
T1N1-2M0, T2N1-2M0 or T3-4NanyM0 at time of initial re-registration.
No evidence of metastatic disease from postoperative pathologic staging.
ECOG performance status of 0, 1, or 2 at re-registration
Curative resection performed
Re-registered 4 - 6 weeks from the date of surgery
WBC ≥ 4000 cells/mm³, platelets ≥ 150,000/mm³, creatinine ≤ 1.5 mg/dl or creatinine clearance of > 50 ml/min (measured or calculated) and total serum bilirubin < 2 mg/dl, all within four weeks prior to re-registration
Exclusion Criteria:
Prior chemotherapy
Clinically significant auditory impairment
Significant heart disease
Pregnant or lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David I. Rosenthal, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Colorado Cancer Research Program, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209-5031
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Veterans Affairs Medical Center - Lakeside Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Veterans Affairs Medical Center - Indianapolis (Roudebush)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
New England Medical Center Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
CCOP - Ann Arbor Regional
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962-1956
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Raritan Bay Medical Center
City
Perth Amboy
State/Province
New Jersey
ZIP/Postal Code
08861
Country
United States
Facility Name
Somerset Medical Center
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Albert Einstein Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
University of Rochester Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
CCOP - Toledo Community Hospital Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
CCOP - Marshfield Medical Research and Education Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Veterans Affairs Medical Center - Milwaukee (Zablocki)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23293700
Citation
Chakravarthy AB, Catalano PJ, Mondschein JK, Rosenthal DI, Haller DG, Whittington R, Spitz FR, Wagner H, Sigurdson ER, Tschetter LK, Bayer GK, Mulcahy MF, Benson AB. Phase II Trial of Paclitaxel/Cisplatin Followed by Surgery and Adjuvant Radiation Therapy and 5-Fluorouracil/Leucovorin for Gastric Cancer (ECOG E7296). Gastrointest Cancer Res. 2012 Nov;5(6):191-7.
Results Reference
result
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Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
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