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Randomized Phase III Trial of Adjuvant Chemotherapy or Chemoradiotherapy in Resectable Gastric Cancer (CRITICS)

NCT00407186 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 788

Last updated 2017-10-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of combined chemotherapy and radiotherapy (in comparison to chemotherapy alone) as adjuvant treatment after surgery for gastric cancer. Prior to surgery all patients will receive neo-adjuvant chemotherapy as well.

Conditions

Interventions

DRUG

cisplatin+capecitabine

cisplatin 20 mg/m2 (i.v., q 1 w, 5 weeks), capecitabine 575 mg/m2 (b.i.d., oral, on radiotherapy days.

RADIATION

radiotherapy

45 Gy in 25 fracions (5 days/week)

DRUG

epirubicin+cisplatin+capecitabine

3 courses q 3 w: epirubicin 50 mg/m2 (i.v., day 1), cisplatin 60 mg/m2 (i.v., day 1), capecitabine 1000 mg/m2 (b.i.d., oral, day 1-14)

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Roche Pharma AG

    collaborator INDUSTRY

  • Dutch Colorectal Cancer Group

    lead OTHER

Principal Investigators

  • Marcel Verheij, MD PhD · Nederlands Kanker Insituut/Antoni van Leeuwenhoek Ziekenhuis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-11
Primary Completion
2018-12-31
Completion
2025-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT00407186 on ClinicalTrials.gov