search
Back to results

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

Primary Purpose

Non Small-cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day
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
Sponsored by
Spanish Lung Cancer Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small-cell Lung Cancer focused on measuring LUNG, DOCETAXEL, GEMCITABINE, CARBOPLATIN, RADIOTHERAPY

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Docetaxel +Carboplatin +concomitant chemoradiation

    C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concom

    Arm Description

    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 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)

    Outcomes

    Primary Outcome Measures

    Overall response rate

    Secondary Outcome Measures

    Local control rate at 1 year
    Time to progression
    Overall Survival

    Full Information

    First Posted
    July 17, 2012
    Last Updated
    July 27, 2012
    Sponsor
    Spanish Lung Cancer Group
    Collaborators
    Aventis Pharmaceuticals
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01652820
    Brief Title
    Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer
    Acronym
    GECP0008
    Official Title
    Randomized Phase II Trial Using Concomitant Chemoradiation Plus Induction or Consolidation Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2001 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    December 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Spanish Lung Cancer Group
    Collaborators
    Aventis Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non Small-cell Lung Cancer
    Keywords
    LUNG, DOCETAXEL, GEMCITABINE, CARBOPLATIN, RADIOTHERAPY

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Docetaxel +Carboplatin +concomitant chemoradiation
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    C) Docetax+ gemcit +concom. docetax + carbopl. + RDT concom
    Arm Type
    Experimental
    Arm Description
    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)
    Intervention Type
    Drug
    Intervention Name(s)
    Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day
    Intervention Type
    Drug
    Intervention Name(s)
    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
    Primary Outcome Measure Information:
    Title
    Overall response rate
    Secondary Outcome Measure Information:
    Title
    Local control rate at 1 year
    Time Frame
    1 year
    Title
    Time to progression
    Title
    Overall Survival

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pilar Garrido, MD
    Organizational Affiliation
    Hospital Ramon y Cajal (Madrid)
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Rafael Rosell, MD
    Organizational Affiliation
    Germans Trias i Pujol Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23611405
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs