Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach

Conditions

• Adenocarcinoma of the Gastroesophageal Junction
• Adenocarcinoma of the Stomach

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin — DRUG
  * Irinotecan (CPT-11) 180 mg/m2, given as 60 min. i.v. infusion on day 1 every 2 weeks followed by * Leucovorin (LV) 100 mg/m2, given as a 2h i.v. infusion on days 1 and 2 every 2 weeks followed by * 5-Fluorouracil (5-FU) 400 mg/m2 given as bolus, and then 5-Fluorouracil (5-FU) 600 mg/m2 given as a 22h continuous infusion on days 1 and 2, every 2 weeks for 4 administrations. After 3 weeks from last infusion: * Docetaxel (TXT) 75 mg/m2, given as a 1h i.v. infusion on day 1 followed by * Cisplatin (CDDP) 75 mg/m2, given as a 1h i.v. infusion on.day 1, every 3 weeks, for 3 cycles.
• Leucovorin, 5-Fluorouracil — DRUG
  * Leucovorin (LV) 100 mg/m2, given as a 2h i.v. infusion on days 1 and 2 every 2 weeks followed by * 5-Fluorouracil (5-FU) 400 mg/m2 given as bolus, and then 5-Fluorouracil (5-FU) 600 mg/m2 given as a 22h continuous infusion on days 1 and 2, every 2 weeks for 9 administrations.

Study Details

Open label, randomised, multicenter, superiority study for efficacy. Patients with histologically proven adenocarcinoma of the stomach or gastroesophageal junction without gross or microscopic evidence of residual disease after surgery with curative intent and fulfilling all the inclusion/exclusion criteria are eligible for this study.

Key Dates

Start date

Feb 28, 2005

Status verified

Dec 2013

Primary completion

Jan 31, 2013

Completion

Jan 31, 2013

Study Design

Enrollment

1,100 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sequential regimen
  Sequential treatment with CPT-11 plus Fluorouracil (FU), folinic acid (LV) and Docetaxel (TXT) plus Cisplatin (CDDP)
• Active Comparator: De Gramont regimen
  Fluorouracil (5-FU), folinic acid (LV)

Primary Outcome Measure

Progression Free Survival will be defined as the time from date of randomisation to date of first appearance of local, regional or distant relapse, or death from any cause; patients alive without relapse will be censored at date last known to be alive. [ Time Frame: 3 years ]