Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer (GECP0008)

Randomized Phase II Trial Using Concomitant Chemoradiation Plus Induction or Consolidation Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer Patients

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 Overview

• Status: Completed
• Conditions: Non Small-cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day; Drug: 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

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Docetaxel +Carboplatin +concomitant chemoradiation; 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)	Drug: Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day; Drug: 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
Experimental: C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concom; 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)	Drug: Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day; Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	The final response rates were 57% (arm B) and 56.9% (arm C). Arm A not available due to early closing	From enrollment to first response assesment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control rate at 1 year		1 year
Time to progression	Arm B: 7.6 months (m) and arm C: 9.2 m; p= 0.12)	From enrollment to first progression date
Overall Survival	Arm B: 14.3 m and arm C: 14.7 m; p= 0.3	From enrollment to last follow up or death

Collaborators and Investigators

• Sponsor: Spanish Lung Cancer Group
• Collaborators: Aventis Pharmaceuticals
• Investigators: Principal Investigator: Pilar Garrido, MD, Hospital Ramon y Cajal (Madrid); Principal Investigator: Rafael Rosell, MD, Germans Trias i Pujol Hospital

Publications and helpful links

General Publications

• Garrido P, Rosell R, Arellano A, Andreu F, Domine M, Perez-Casas A, Cardenal F, Arnaiz Mdel M, Moran T, Morera R, Isla D, Valencia J, Cobo M, Delgado R, Garcia-Gomez R, Calvo F, Zamora J, Ramos A, Massuti B. Randomized phase II trial of non-platinum induction or consolidation chemotherapy plus concomitant chemoradiation in stage III NSCLC patients: mature results of the Spanish Lung Cancer Group 0008 study. Lung Cancer. 2013 Jul;81(1):84-90. doi: 10.1016/j.lungcan.2013.03.009. Epub 2013 Apr 21.

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 27, 2012
• First Posted (Estimated): July 30, 2012

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: CARBOPLATIN; LUNG; GEMCITABINE; DOCETAXEL; RADIOTHERAPY
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Gemcitabine; Carboplatin
• Other Study ID Numbers: GECP 00-08 / TAX.ES1.209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO