NCT00617656

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

Multicenter Phase III, Randomized Study to Evaluate Treatment Customized According to RAP80 and BRCA1 Assessment in Patients With Advanced Non-small-cell Lung Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 382 (actual)
• Sponsor: Spanish Lung Cancer Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study population: Patients with advanced non-small-cell lung cancer who have not received treatment for the disease at this stage and who have a good performance status (ECOG 0-1) and measurable disease (at least one target lesion according to RECIST criteria). Duration of treatment: Six chemotherapy cycles will be given. The duration of every cycle will be 21 days. If the treatment is beneficial, it may be prolonged to a total of 8 cycles at the discretion of the investigator. Calendar and planned finalization date: The approximate duration of the study is 3 years of recruitment followed by 1 year of follow-up.

Conditions

• Non Small Cell Lung Cancer
• BRCA1 Mutation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2008-02-18
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

44 sites across 1 country: Spain