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Cisplatin/Etoposide/Radiotherapy +/- Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer

NCT00216125 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2016-03-16

Study results available
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Summary

In a previous phase II study, patients with pathological stage IIIb (without pleural effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was selected based upon a survival benefit in patients with recurrent NSCLC.

This trial will evaluate the role of consolidation therapy with docetaxel in patients with unresectable stage III disease. The purpose of the trial is to evaluate survival and toxicities of the regimens employed.

Conditions

Interventions

DRUG

Cisplatin

Cisplatin 50 mg/m2 day 1, 8, 29, 36

DRUG

Etoposide

Etoposide 50 mg/m2, days 1-5, 29-33

RADIATION

Radiation

Radiation 5940 cGy (180 cGy/day)

DRUG

Docetaxel

docetaxel 75mg/m2 q3wk x 3 cycles

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Walther Cancer Institute

    collaborator OTHER

  • Nasser Hanna, M.D.

    lead OTHER

Principal Investigators

  • Nasser Hanna, M.D. · Hoosier Oncology Group, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2006-06-30
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00216125 on ClinicalTrials.gov