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

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Spanish Lung Cancer Group
ClinicalTrials.gov Identifier:
NCT01652820
First received: July 17, 2012
Last updated: July 27, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Non Small-cell Lung Cancer
 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
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial Using Concomitant Chemoradiation Plus Induction or Consolidation Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Spanish Lung Cancer Group:

Primary Outcome Measures:
  • Overall response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local control rate at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall Survival [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: October 2001
Study Completion Date: December 2007
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652820

Sponsors and Collaborators
Spanish Lung Cancer Group
Aventis Pharmaceuticals
Investigators
Principal Investigator: Pilar Garrido, MD Hospital Ramon y Cajal (Madrid)
Principal Investigator: Rafael Rosell, MD HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL
  More Information

No publications provided

Responsible Party: Spanish Lung Cancer Group
ClinicalTrials.gov Identifier: NCT01652820     History of Changes
Other Study ID Numbers: GECP 00-08 / TAX.ES1.209
Study First Received: July 17, 2012
Last Updated: July 27, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Lung Cancer Group:
LUNG
DOCETAXEL
GEMCITABINE
CARBOPLATIN
RADIOTHERAPY

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Docetaxel
Carboplatin
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 19, 2013