Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

NCT00215514 | Completed Early Phase 1 DMC

• 1 other identifier: 00-165
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

The main purpose of this trial is to determine how well patients with gastric or gastroesophageal junction adenocarcinoma respond to chemotherapy with epirubicin, cisplatin and 5-fluorouracil followed by continuous infusion 5-fluorouracil chemotherapy given along with radiation therapy.

Conditions

Stomach Cancer; Gastric Cancer; Gastro-esophageal Junction Cancer

Keywords

adjuvant chemoradiation; GE junction; epirubicin

Outcome Measures

Primary Outcomes (1)

• To assess patient tolerance and toxicity of postoperative adjuvant regimen using epirubicin, cisplatin, and infusional 5-FU before and after a course of radiotherapy among patients with curatively resected gastric or gastroesophageal adenocarcinoma.

  3 years

Study Arms (1)

ECF followed by 5-FU/RT followed by ECF

EXPERIMENTAL

Drug: Epirubicin; Drug: Cisplatin; Drug: 5-Fluorouracil (5-FU); Procedure: Radiation

Interventions

Epirubicin DRUG

Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> One-week rest --\> External Beam Radiation Therapy plus 5-FU CI --\> Four-week rest --\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).

ECF followed by 5-FU/RT followed by ECF

Cisplatin DRUG

Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> One-week rest --\> External Beam Radiation Therapy plus 5-FU CI --\> Four-week rest --\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).

ECF followed by 5-FU/RT followed by ECF

5-Fluorouracil (5-FU) DRUG

Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> One-week rest --\> External Beam Radiation Therapy plus 5-FU CI --\> Four-week rest --\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).

ECF followed by 5-FU/RT followed by ECF

Radiation PROCEDURE

Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> One-week rest --\> External Beam Radiation Therapy plus 5-FU CI --\> Four-week rest --\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21)--\> Epirubicin (Day 1), Cisplatin (Day 1), 5-FU (Days 1-21).

ECF followed by 5-FU/RT followed by ECF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinomas of the esophagus that are not involving the gastroesophageal junction are not eligible.
• Patients must have had en bloc resection of all known tumor and be at high risk for later failure. The surgical resection must have been done with a curative intent. The stomach, lver, peritoneum, omentum and regional lymph nodes must be evaluated and all identified tumor be resected.
• The surgical specimen, and the pathologic analysis thereof, must be adequate for TNM staging.
• Treatment must begin between day 20 and day 56 after the gastrectomy.
• ECOG performance status of 0,1 or 2
• ANC \> 1,500/ul and platelet count \>100,000/ul
• Serum creatinine \< 1.5mg/dl
• Total bilirubin \< 2.0 mg/dl and AST \< 3 x ULN
• Estimated caloric intake of 1500K calories per day or greater

You may not qualify if:

• Known unresected cancer, microscopic evidence of tumor at the line of resection, noncontiguous resection of tumor, or M1 disease
• Ascites, peritoneal seeding, liver metastasis or extra-abdominal metastasis
• Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, non-invasive carcinoma in situ which has been fully resected, or other cancer for which the patient has been disease free for five years
• Previous chemotherapy or radiotherapy
• Active infectious process
• Pregnant or lactating women
• Myocardial infarction in the past 6 months or prior history of congestive heart failure or significant valvular heart disease
• Uncontrolled serious medical or psychiatric condition
• Grade 2 or greater peripheral neuropathy at baseline

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Epirubicin; Cisplatin; Fluorouracil; Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Physical Phenomena

Study Officials

• Charles S. Fuchs, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2000
• Primary Completion: November 1, 2003
• Study Completion: July 1, 2014
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

US (3)