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

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

June 1, 1999

Primary Completion Date

February 28, 2010

Study Completion Date

May 31, 2011

Conditions
Gastric Cancer
Interventions
DRUG

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.

DRUG

fluorouracil

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

DRUG

leucovorin calcium

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

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.

PROCEDURE

surgery

"The surgical procedure performed involved a radical subtotal or total gastrectomy.~A complete surgical resection was required"

RADIATION

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

Trial Locations (30)

10461

Albert Einstein Comprehensive Cancer Center, The Bronx

14642

University of Rochester Cancer Center, Rochester

19096

CCOP - MainLine Health, Wynnewood

30322

Emory University Hospital - Atlanta, Atlanta

37212

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

46202

Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis

48106

CCOP - Ann Arbor Regional, Ann Arbor

53226

Medical College of Wisconsin, Milwaukee

53295

Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee

54449

CCOP - Marshfield Medical Research and Education Foundation, Marshfield

55416

CCOP - Metro-Minnesota, Saint Louis Park

60201

CCOP - Evanston, Evanston

60611

Veterans Affairs Medical Center - Lakeside Chicago, Chicago

61801

CCOP - Carle Cancer Center, Urbana

68131

CCOP - Missouri Valley Cancer Consortium, Omaha

70121

CCOP - Ochsner, New Orleans

80209-5031

CCOP - Colorado Cancer Research Program, Inc., Denver

60611-3013

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago

46202-5289

Indiana University Cancer Center, Indianapolis

52403-1206

CCOP - Cedar Rapids Oncology Project, Cedar Rapids

02111

New England Medical Center Hospital, Boston

49007-3731

CCOP - Kalamazoo, Kalamazoo

07962-1956

Morristown Memorial Hospital, Morristown

08901

Cancer Institute of New Jersey, New Brunswick

08861

Raritan Bay Medical Center, Perth Amboy

08876

Somerset Medical Center, Somerville

44106-5065

Ireland Cancer Center, Cleveland

43623-3456

CCOP - Toledo Community Hospital Oncology Program, Toledo

19104-4283

University of Pennsylvania Cancer Center, Philadelphia

37232-6838

Vanderbilt-Ingram Cancer Center, Nashville

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

ECOG-ACRIN Cancer Research Group

NETWORK

NCT00003298 - Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer | Biotech Hunter | Biotech Hunter