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Combination Chemotherapy, Cetuximab and Radiation for Patients With Localized Gastric Cancer

NCT01611506 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2013-01-09

No results posted yet for this study

Summary

RATIONALE: Radiotherapy is currently the most efficient way to induce pathologic responses, which are associated with a favorable prognosis in localized tumors. Novel radiotherapy techniques are associated with significantly less toxicity than traditional radiation protocols and permit to avoid the toxicity to adjacent organs. Established chemotherapy regimens, such as cisplatin and capecitabine, and monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Giving radiation therapy together with cisplatin and cetuximab before surgery aims to induce a pathological response and improve the prognosis after surgery.

PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy when given together with cisplatin and cetuximab in treating patients who are undergoing surgery for locally advanced gastric cancer.

Conditions

Interventions

BIOLOGICAL

Cetuximab

Induction chemotherapy: Cetuximab 400mg/m2 (loading dose) on day 1 Cetuximab 250mg/m2 weekly thereafter Followed by: Cetuximab 250mg/m2 weekly on day 1 during chemoradiation Postoperative treatment: 3 cycles of Cetuximab 250mg/m2 weekly on day 1

DRUG

Capecitabine

Induction chemotherapy: Capecitabine 1000mg/m2 twice daily from the evening of day 1 to the morning of day 15 within each 3 weeks cycle Postoperative treatment: Capecitabine 1000mg/m2 twice daily from the evening of day 1 to the morning of day 15 within each 3 weeks cycle

DRUG

Cisplatin

Induction chemotherapy: Cisplatin 80mg/m2 on day 1 of each 21 day cycle Followed by: Cisplatin 30mg/m2 weekly on day 1 during chemoradiation Postoperative treatment: Cisplatin 80mg/m2 on day 1 of each 21 day cycle

Sponsors & Collaborators

  • Dr Anna Dorothea Wagner

    lead OTHER

Principal Investigators

  • Anna Dorothea Wagner, MD · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Switzerland

Study Locations

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Entities

Drugs
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 NCT01611506 on ClinicalTrials.gov