NCT00215514

Adjuvant Chemoradiation Therapy for Gastric or Gastroesophageal Junction Adenocarcinoma

A Pilot Study of Adjuvant Chemoradiation After Resection of Gastric Or Gastroesophageal Junction Adenocarcinoma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* Patients will receive epirubicin and cisplatin intravenously on day 1 of treatment. 5-fluorouracil will be given continuously by intravenous infusion bia a portable ambulatory pump (CADD pump) for 21 days. This cycle of chemotherapy will take 21 days (3 weeks). Once it is complete there will be one week without therapy. * Once the patient has recovered from any side-effects from the chemotherapy they will start the combination chemoradiation therapy, 5-fluorouracil and radiation. The radiation will be directed to the upper abdomen in the area where the stomach tumor has been located. The radiation therapy will be given five days a week for a total of five weeks. During these five weeks patients will receive 5-fluorouracil continuously by CADD pump. * After completion of combination chemoradiation therapy there will be a three to four week rest period followed by 2 additional chemotherapy cycles identical to the first chemotherapy cycle. * The following tests and procedures will be performed: physical examination every 4 weeks except during the chemoradiation therapy when it will be done weekly; blood tests every week during chemotherapy and chemoradiation; CT scans and chest x-rays done before therapy, at the end of therapy, and yearly for 2 years; noninvasive testing to evaluate kidney function before starting the study. * The program of chemotherapy and radiation therapy will last approximately 30 weeks. After all treatment is completed, patients will return for physical examinations and blood tests every 3 months for 3 years; then every 6 months for 2 years.

Conditions

• Stomach Cancer
• Gastric Cancer
• Gastro-esophageal Junction Cancer

Interventions

Type	Name	Description
DRUG	Epirubicin	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).
DRUG	Cisplatin	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).
DRUG	5-Fluorouracil (5-FU)	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).
PROCEDURE	Radiation	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).

Timeline

• Start date: 2000-09-01
• Primary completion: 2003-11-01
• Completion: 2014-07-01
• First posted: 2005-09-22
• Last updated: 2014-07-29

Locations

3 sites across 1 country: United States