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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)


Phase 3
18 Years
69 Years
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

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)


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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival

Principal Investigator

Michael Thomas, Prof. / MD

Investigator Role:

Study Chair

Investigator Affiliation:

Current affiliation: Thoraxklinik am Universitätsklinikum Heidelberg

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GLCCG01/95

NCT ID:

NCT00176137

Start Date:

October 1995

Completion Date:

September 2005

Related Keywords:

  • Non-Small Cell Lung Cancer
  • multimodality treatment
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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