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Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)

NCT00176137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2008-04-22

No results posted yet for this study

Summary

Patients are randomized to (arm A) 3 cycles of cisplatin/etoposide, followed by hyperfractionated radiotherapy (hfRT)with concurrent carboplatin and vindesine then surgery and, if no or R1/2-resection, additional hfRT versus (arm B) 3 cycles of cisplatin/etoposide, followed by surgery and then RT.

The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

Conditions

Interventions

PROCEDURE

preoperative radiochemotherapy

Sponsors & Collaborators

  • University Hospital Muenster

    collaborator OTHER

  • Lung Clinic Hemer

    collaborator OTHER

  • Kreiskrankenhaus Diekholzen

    collaborator UNKNOWN

  • University Hospital, Saarland

    collaborator OTHER

  • FLT Berlin / Buch

    collaborator UNKNOWN

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Michael Thomas, Prof. / MD · Current affiliation: Thoraxklinik am Universitätsklinikum Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
1995-10-31
Completion
2005-09-30

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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 NCT00176137 on ClinicalTrials.gov