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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-10-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Non-Small Cell Lung Cancer

Keywords

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multimodality treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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preoperative radiochemotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Michael Thomas, Prof. / MD

Role: STUDY_CHAIR

Current affiliation: Thoraxklinik am Universitätsklinikum Heidelberg

Countries

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Germany

References

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Kreuter M, Kropff M, Fischaleck A, Junker K, Gerss J, Heinecke A, Lindermann M, Reinmuth N, Berdel WE, Mesters RM, Thomas M. Prognostic relevance of angiogenesis in stage III NSCLC receiving multimodality treatment. Eur Respir J. 2009 Jun;33(6):1383-8. doi: 10.1183/09031936.00121108. Epub 2009 Feb 12.

Reference Type DERIVED

PMID: 19213790 (View on PubMed)

Thomas M, Rube C, Hoffknecht P, Macha HN, Freitag L, Linder A, Willich N, Hamm M, Sybrecht GW, Ukena D, Deppermann KM, Droge C, Riesenbeck D, Heinecke A, Sauerland C, Junker K, Berdel WE, Semik M; German Lung Cancer Cooperative Group. Effect of preoperative chemoradiation in addition to preoperative chemotherapy: a randomised trial in stage III non-small-cell lung cancer. Lancet Oncol. 2008 Jul;9(7):636-48. doi: 10.1016/S1470-2045(08)70156-6. Epub 2008 Jun 24.

Reference Type DERIVED

PMID: 18583190 (View on PubMed)

Other Identifiers

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German Cancer Aid

Identifier Type: -

Identifier Source: secondary_id

GLCCG01/95