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Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma

NCT00311467 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2012-05-16

No results posted yet for this study

Summary

Multi-center, prospective randomised phase III study evaluating capecitabine in combination with standard-immunotherapy versus standard-immunotherapy alone as first-line therapy in patients with metastatic renal cell carcinoma.

Conditions

  • Renal Cell Cancer

Interventions

DRUG

Capecitabine, Interferon, Interleukin

Capecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days. Interferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d. Interleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day. Group B Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine. Efficacy evaluations will be performed every 14 weeks of treatment in both groups

Sponsors & Collaborators

  • Central European Cooperative Oncology Group

    lead OTHER

Principal Investigators

  • Manuela Schmidinger, Prof · Univ. Klinik f. Innere Med. I, Abt. Onkologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • Austria

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 NCT00311467 on ClinicalTrials.gov