Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer

Spanish Lung Cancer Group140 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Non Small-cell Lung Cancer

Interventions

Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall response rate

The final response rates were 57% (arm B) and 56.9% (arm C). Arm A not available due to early closing

Time frame: From enrollment to first response assesment

Secondary Outcomes

Local control rate at 1 year

Time frame: 1 year

Time to progression

Arm B: 7.6 months (m) and arm C: 9.2 m; p= 0.12)

Time frame: From enrollment to first progression date

Overall Survival

Arm B: 14.3 m and arm C: 14.7 m; p= 0.3

Time frame: From enrollment to last follow up or death