Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
A Phase II Trial of Neoadjuvant Paclitaxel - Cisplatin Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer
4 other identifiers
interventional
39
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 gastric-cancer
Started Jun 1999
Longer than P75 for phase_2 gastric-cancer
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 23, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
June 23, 2015
CompletedJuly 6, 2023
June 1, 2023
10.7 years
November 1, 1999
June 2, 2015
June 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)
Secondary Outcomes (3)
Best Confirmed Response to Neoadjuvant Therapy
Assessed at surgery time (surgery performed during week 8-10 after registration to the study)
Overall Survival
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
Progression Free Survival
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
Study Arms (1)
Experimental Arm
EXPERIMENTALPatients 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.
Interventions
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.
Postoperative regimen 5-FU, along with Leucovorin, was given by IV bolus, with 5-FU given immediately after the Leucovorin
Both 5-FU and Leucovorin will be given via IV bolus, with Leucovorin given immediately before 5-FU.
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.
The surgical procedure performed involved a radical subtotal or total gastrectomy. A complete surgical resection was required
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
Eligibility Criteria
You may qualify if:
- 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
- +6 more criteria
You may not qualify if:
- Prior chemotherapy
- Clinically significant auditory impairment
- Significant heart disease
- Pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ECOG-ACRIN Cancer Research Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (30)
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611, United States
CCOP - Evanston
Evanston, Illinois, 60201, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206, United States
CCOP - Ochsner
New Orleans, Louisiana, 70121, United States
New England Medical Center Hospital
Boston, Massachusetts, 02111, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Raritan Bay Medical Center
Perth Amboy, New Jersey, 08861, United States
Somerset Medical Center
Somerville, New Jersey, 08876, United States
University of Rochester Cancer Center
Rochester, New York, 14642, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461, United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295, United States
Related Publications (1)
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.
PMID: 23293700RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study statistician
- Organization
- ECOG-ACRIN Statistical Office
Study Officials
- STUDY CHAIR
David I. Rosenthal, MD
Abramson Cancer Center at Penn Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 23, 2004
Study Start
June 1, 1999
Primary Completion
February 1, 2010
Study Completion
May 1, 2011
Last Updated
July 6, 2023
Results First Posted
June 23, 2015
Record last verified: 2023-06