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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 M√ľnster 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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