Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer
Phase 2
Completed
- Conditions
- Non Small-cell Lung Cancer
- Interventions
- Registration Number
- NCT01652820
- Lead Sponsor
- Spanish Lung Cancer Group
- Brief Summary
Randomized study in 2 arms, without any masking in patients with non small cell lung cancer, histologically or cytologically confirmed, not liable to surgery, stage IIIB or IIIA, according to the TNM classification of the American Joint Committee for cancer. In one arm will be administered concomitant radiotherapy and carboplatin-docetaxel-gemcitabine followed by docetaxel and, in the other arm will be administered docetaxel-gemcitabine followed by concurrent radiotherapy with carboplatin-docetaxel
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
- Unresectable stage IIIA or B NSCLC patients
- WHO PS 0 or 1
- Weight loss < 5 % within the last 3 months
- At least one measurable lesion
- Planning CT scan previous to randomization
- Written informed consent
Exclusion Criteria
- Malignant effusion, supraclavicular node or SVCS
- PTV > 2000 cm3
- V20 > 35%
- FEV1 and DLCO both < 30% or 1 liter at study entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Docetaxel +Carboplatin +concomitant chemoradiation Docetaxel 40mg<7m2 d1,8, 21, 28+ gemcitabine 1200mg/m2 d1,8, 21, 28 + concomitant docetaxel 20mg/m2/w+carboplatin AUC 2/w+ concomitant RDT 2Gy/d Docetaxel 20 mg/m2/weekly plus carboplatin AUC 2/weekly (first, docetaxel will be administered and after that, carboplatin will be administered) and concomitant chemoradiation (total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks) Docetaxel +Carboplatin +concomitant chemoradiation Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day Docetaxel 20 mg/m2/weekly plus carboplatin AUC 2/weekly (first, docetaxel will be administered and after that, carboplatin will be administered) and concomitant chemoradiation (total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks) C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concom Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day Docetaxel 40 mg/ m2 days 1, 8, 21 y 28 plus gemcitabine 1200 mg/ m2 days 1, 8, 21 y 28 followed by concomitant treatment Docetaxel 20 mg/m2/week plus carboplatin AUC 2/weekly and concomitant chemoradiation total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks) C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concom Docetaxel 40mg<7m2 d1,8, 21, 28+ gemcitabine 1200mg/m2 d1,8, 21, 28 + concomitant docetaxel 20mg/m2/w+carboplatin AUC 2/w+ concomitant RDT 2Gy/d Docetaxel 40 mg/ m2 days 1, 8, 21 y 28 plus gemcitabine 1200 mg/ m2 days 1, 8, 21 y 28 followed by concomitant treatment Docetaxel 20 mg/m2/week plus carboplatin AUC 2/weekly and concomitant chemoradiation total dose of 60 Gy: 2 Gy/day, 5 days(week for 6 weeks)
- Primary Outcome Measures
Name Time Method Overall response rate From enrollment to first response assesment The final response rates were 57% (arm B) and 56.9% (arm C). Arm A not available due to early closing
- Secondary Outcome Measures
Name Time Method Local control rate at 1 year 1 year Time to progression From enrollment to first progression date Arm B: 7.6 months (m) and arm C: 9.2 m; p= 0.12)
Overall Survival From enrollment to last follow up or death Arm B: 14.3 m and arm C: 14.7 m; p= 0.3