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

Non Small-cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652820
• Other study ID #: GECP 00-08 / TAX.ES1.209
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2012
• Last updated: July 27, 2012
• Start date: October 2001
• Est. completion date: December 2007

Study information

• Verified date: July 2012
• Source: Spanish Lung Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2007
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small-cell Lung Cancer

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Lung Cancer Group	Aventis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate			No
Secondary	Local control rate at 1 year		1 year	No
Secondary	Time to progression			No
Secondary	Overall Survival			No