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Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach

NCT01640782 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2014-07-18

No results posted yet for this study

Summary

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.

Conditions

  • Adenocarcinoma of the Stomach
  • Adenocarcinoma of the Gastroesophageal Junction

Interventions

DRUG

Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin

* 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.

DRUG

Leucovorin, 5-Fluorouracil

* 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.

Sponsors & Collaborators

  • Aventis Pharmaceuticals

    collaborator INDUSTRY

  • Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

    collaborator OTHER

  • Gruppo Oncologico Italiano di Ricerca Clinica

    collaborator OTHER

  • Gruppo Oncologico del Nord-Ovest

    collaborator OTHER

  • Italian Trial in Medical Oncology

    collaborator OTHER

  • Southern Italy Cooperative Oncology Group

    collaborator OTHER

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

    collaborator OTHER

  • Oncotech

    collaborator INDUSTRY

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Emilio Bajetta, MD · Istituto Nazionale Per lo Studio e la Cura dei Tumori Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640782 on ClinicalTrials.gov