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A Phase II Trial of Neoadjuvant Cisplatin - Fluorouracil Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

Thank you

Trial Information

A Phase II Trial of Neoadjuvant Cisplatin - Fluorouracil Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer


OBJECTIVES: I. Evaluate the tolerability and toxic effects of neoadjuvant cisplatin plus
paclitaxel and postoperative chemoradiation therapy with fluorouracil plus leucovorin
calcium in patients with high-risk gastric cancer. II. 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.

Inclusion Criteria


DISEASE CHARACTERISTICS: 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

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC
at least 4,000 cells/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin less than
2 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 50
mL/min Other: No clinically significant auditory impairment 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 Not pregnant or lactating
Fertile patients must use adequate contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy,
except for skin cancer Surgery: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David I. Rosenthal, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Federal Government

Study ID:

CDR0000066237

NCT ID:

NCT00003298

Start Date:

February 1999

Completion Date:

Related Keywords:

  • Gastric Cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • adenocarcinoma of the stomach
  • Stomach Neoplasms

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Rochester Cancer CenterRochester, New York  14642
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado  80209-5031
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Medical College of WisconsinMilwaukee, Wisconsin  53226
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville CampusNashville, Tennessee  37212
Somerset Medical CenterSomerville, New Jersey  08876
Raritan Bay Medical CenterPerth Amboy, New Jersey  08861