Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer

NCT ID: NCT00003298

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-06-01
• Study Completion Date: 2011-05-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

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.

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

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.

fluorouracil

Intervention Type: DRUG

Postoperative regimen 5-FU, along with Leucovorin, was given by IV bolus, with 5-FU given immediately after the Leucovorin

leucovorin calcium

Intervention Type: DRUG

Both 5-FU and Leucovorin will be given via IV bolus, with Leucovorin given immediately before 5-FU.

paclitaxel

Intervention Type: DRUG

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.

surgery

Intervention Type: PROCEDURE

The surgical procedure performed involved a radical subtotal or total gastrectomy.

A complete surgical resection was required

radiation therapy

Intervention Type: RADIATION

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

Interventions

cisplatin

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

fluorouracil

Postoperative regimen 5-FU, along with Leucovorin, was given by IV bolus, with 5-FU given immediately after the Leucovorin

Intervention Type: DRUG

leucovorin calcium

Both 5-FU and Leucovorin will be given via IV bolus, with Leucovorin given immediately before 5-FU.

Intervention Type: DRUG

paclitaxel

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: DRUG

surgery

The surgical procedure performed involved a radical subtotal or total gastrectomy.

A complete surgical resection was required

Intervention Type: PROCEDURE

radiation therapy

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

Intervention Type: RADIATION

Other Intervention Names

Platinol; cis-platinum; cisdiamminedichloroplatinum (II); Platinol-AQ; DACP; platinum; CDDP; DDP; 5-Fluorouracil; 5-FU; Adrucil; Efudex; Leucovorin; Wellcovorin; citrovorum factor; folinic acid; 5-formyl tetrahydrofolate; LV; LCV; Taxol®; NSC 125973

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David I. Rosenthal, MD

Role: STUDY_CHAIR

Abramson Cancer Center at Penn Medicine

Locations

CCOP - Colorado Cancer Research Program, Inc.

Denver, Colorado, United States

Emory University Hospital - Atlanta

Atlanta, Georgia, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, United States

CCOP - Evanston

Evanston, Illinois, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, United States

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

CCOP - Ochsner

New Orleans, Louisiana, United States

New England Medical Center Hospital

Boston, Massachusetts, United States

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Raritan Bay Medical Center

Perth Amboy, New Jersey, United States

Somerset Medical Center

Somerville, New Jersey, United States

University of Rochester Cancer Center

Rochester, New York, United States

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, United States

Ireland Cancer Center

Cleveland, Ohio, United States

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

CCOP - MainLine Health

Wynnewood, Pennsylvania, United States

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

CCOP - Marshfield Medical Research and Education Foundation

Marshfield, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23293700 (View on PubMed)

Other Identifiers

E7296

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA023318

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCT00003298

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000066237

Identifier Type: -

Identifier Source: org_study_id