Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Cisplatin/Etoposide Followed by Twice-Daily Chemoradiation (hfRT/CT) Versus Cisplatin/Etoposide Alone Before Surgery in Stage III Non-Small Cell Lung Cancer. A Phase III Trial of the German Lung Cancer Cooperative Group (GLCCG)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00176137
• Other study ID #: GLCCG01/95
• Secondary ID: German Cancer Ai
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: April 21, 2008
• Start date: October 1995
• Est. completion date: September 2005

Study information

• Verified date: April 2008
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Patients are randomized to (arm A) 3 cycles of cisplatin/etoposide, followed by hyperfractionated radiotherapy (hfRT)with concurrent carboplatin and vindesine then surgery and, if no or R1/2-resection, additional hfRT versus (arm B) 3 cycles of cisplatin/etoposide, followed by surgery and then RT.

The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

Description:

Patients are randomized to (arm A) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4), followed by hyperfractionated radiotherapy (hfRT; 45 Gy, 2x1.5 Gy/d) with concurrent carboplatin (100 mg/m2) and vindesine (3 mg) (d 1, 8, 15), then surgery and, if no or R1/2-resection, additional hfRT (24 Gy; 2x1.5 Gy/d) versus (arm B) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4),followed by surgery and then RT (1.8 Gy/d) with 54 Gy or, if no or R1/2-resection, 68.4 Gy.

The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

(University of Münster was the lead sponsor; as the trial was implemented in clinicaltrials.gov by the principal investigator after he had moved to University of Heidelberg this account is announced above)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• non-small cell lung cancer proven by histology

• stage IIIA / stage IIIB

• mediastinoscopy

• performance score ECOG 0,1

• predicted postoperative FEV 1 > 1.0 l

Exclusion Criteria:

• small cell lung cancer

• cardiac disability (NYHA III/IV)

• prior radio- or chemotherapy

• pregnancy

• other malignancy

Study Design

Allocation: Randomized, Endpoint Classification: 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

Procedure:
• preoperative radiochemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Heidelberg University	FLT Berlin / Buch, Kreiskrankenhaus Diekholzen, Lung Clinic Hemer, University Hospital Muenster, University Hospital, Saarland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival
Secondary	Overall survival