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OpenTrials
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NCT Number: NCT01652820

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

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

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Key information

Conditions

Non Small-cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. Local control rate at 1 year

    Time frame: 1 year

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

Spanish Lung Cancer Group

Other

Collaborators

  • Aventis Pharmaceuticals

Registry information

Official study title

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

Acronym: GECP0008

Important dates

Study start
2001
Primary completion
2006
Study completion
2007
First posted
Jul 30, 2012
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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