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The Role of Postoperative Cycles in the Perioperative Chemotherapy for Gastric Cancer

NCT01787539 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2013-02-08

No results posted yet for this study

Summary

Taking into account the substantial doubts concerning the potential benefit of postoperative part in the perioperative chemotherapy regimen we designed a study assessing value of this approach in gastric cancer. To improve compliance with a protocol regimen of this aggressive combined therapy we replaced tested in the MAGIC trial ECF regimen with more effective and better tolerable EOX chemotherapy regimen. The value of postoperative three-cycle EOX regimen will be tested in patients with locoregionally advanced gastric cancer with positive pathological response to preoperative three-cycle EOX chemotherapy regimen. The patients will be randomized to the postoperative chemotherapy or to the follow-up arm.

Conditions

Interventions

DRUG

Postoperative Chemotherapy

Postoperative chemotherapy with EOX regimen: Epirubicin with intravenous bolus at a dose of 50 mg/m2 an on day 1; Oxaliplatin with intravenous infusion during a 2-hour period at a dose of 130 mg/m2; Capecitabine administrated orally at a twice daily dose of 625 mg /m2 during 21 days. Treatment cycles will be repeated every 3 weeks. Postoperative chemotherapy will be administrated in patients with tumor regression grade 0, 1, 2 randomized to perioperative chemotherapy and will be initiated 6 to 12 weeks after surgery.

Sponsors & Collaborators

  • St Johns' Oncology Center in Lublin

    collaborator UNKNOWN

  • Medical University of Lublin

    lead OTHER

Principal Investigators

  • Tomasz Skoczylas, MD, PhD · Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

  • Grzegorz Wallner, Professor · Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

  • Elżbieta Starosławska, MD, PhD · St Johns' Oncology Center in Lublin

  • Tomasz Kubiatowski, MD, PhD · St Johns' Oncology Center in Lublin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2017-02-28
Completion
2022-02-28

Countries

  • Poland

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 NCT01787539 on ClinicalTrials.gov