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Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy

NCT00349089 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2019-09-19

No results posted yet for this study

Summary

The purpose of this randomized phase II trial is to determine the clinical feasibility - in terms of patients without dose limiting toxicities or premature treatment withdrawal or death - of the combination of Cisplatin and Pemetrexed and of the combination of Cisplatin and Vinorelbine. The combination of Cisplatin / Pemetrexed is assumed to be distinctly less toxic than Vinorelbine / Cisplatin.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Pemetrexed

Pemetrexed 500 mg/m2 d1 and Cisplatin 75 mg/m2 d1; q d22

DRUG

Cisplatin

Pemetrexed 500 mg/m2 d1 and Cisplatin 75 mg/m2 d1; q d22 Comparator: Vinorelbine 25 mg/m2 d1, 8, 15, 22; q d29 Cisplatin 50 mg/m2 d1, 8; q d29

DRUG

Vinorelbine

Vinorelbine 25 mg/m2 d1, 8, 15, 22; q d29

Sponsors & Collaborators

  • Thoraxklinik-Heidelberg gGmbH

    lead OTHER

Principal Investigators

  • Michael Thomas, Prof. Dr. · Clinic for thoracic diseases at the University of Heidelberg, Germany

  • Michael Kreuter, Dr. · Clinic for thoracic diseases at the University of Heidelberg, Germany

  • Johan Vansteenkiste, Prof. Dr. · Department of Pulmonology (Respiratory Tumor Unit), University Hospital Gasthuisberg, Catholic University Leuven, Belgium

  • Frank Griesinger, Prof. Dr. · Department of Hematology and Oncology, Oldenburg, Germany.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-09-26
Primary Completion
2014-04-14
Completion
2014-04-14

Countries

  • Belgium
  • Germany
  • Luxembourg

Study Locations

More Related Trials

Entities

Drugs

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 NCT00349089 on ClinicalTrials.gov