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

May 19, 2025 updated by: Spanish Lung Cancer Group

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
From enrollment to first response assesment

Secondary Outcome Measures

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GECP 00-08 / TAX.ES1.209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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