Study to Evaluate Safety and Efficacy of Perioperative Chemotherapy With Docetaxel, Cisplatin and Capecitabine (DCX) in Patients With Gastro-esophageal Cancer

NCT00865982 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-08-05

No results posted yet for this study

Summary

In this study, patients with adenocarcinoma of the stomach, gastro-esophageal junction or the distal esophagus who seem operable with curative intent according to oncological and surgical assessment are treated with 3 preoperative cycles of DCX (Docetaxel, Cisplatin, Capecitabine) followed by surgical resection, followed by 3 postoperative cycles of DCX.

Conditions

Interventions

DRUG

Docetaxel, Cisplatin, Capecitabine

3 preoperative cycles with Docetaxel 75 mg/m² d1 Cisplatin 60 mg/m² d1 Capecitabine 1875 mg/m²/day d1-14 repeated every 3 weeks followed by resection and 3 postoperative cycles with Docetaxel 75 mg/m² d1 Cisplatin 60 mg/m² d1 Capecitabine 1875 mg/m²/day d1-14 repeated every 3 weeks.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY
  • Sanofi

    collaborator INDUSTRY
  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Peter Thuss-Patience, Dr. med. · Charite University, Berlin, Germany

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
2008-09-30
Primary Completion
2014-09-30
Completion
2015-09-30

Countries

  • Germany

Study Locations

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Entities

Companies

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 NCT00865982 on ClinicalTrials.gov