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Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma

NCT00617656 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2024-01-30

Study results available
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Summary

Primary objective:

· Progression free survival.

Secondary objectives:

* Assess Overall survival of both treatment groups.
* Assess Tumor response rate using RECIST criteria
* Assess Toxicity profile of patients enrolled in the study.
* Exploratory evaluation of potential genetic markers of response or resistance to chemotherapy.

Conditions

  • Non Small Cell Lung Cancer
  • BRCA1 Mutation

Interventions

DRUG

Cisplatin, Docetaxel

Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6

DRUG

Gemcitabine, Cisplatin

Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

DRUG

Docetaxel, Cisplatin

Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6

DRUG

Docetaxel

Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Sponsors & Collaborators

  • Spanish Lung Cancer Group

    lead OTHER

Principal Investigators

  • Rafel Rossell, MD · Principal Investigator of Fundación Grupo Español de Cáncer de Pulmón

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Spain

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 NCT00617656 on ClinicalTrials.gov