Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Over 18 Other EORTC-08941 NCT00002623

Objectives

1. Compare the overall survival of patients with stage IIIA non-small cell lung cancer treated with surgery with or without radiotherapy versus radiotherapy alone after achieving a response to a neoadjuvant chemotherapy regimen containing cisplatin or carboplatin.
2. Compare the progression-free survival of patients treated with these regimens.
3. Compare the toxic effects of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically proven primary unresectable non-small cell lung cancer (NSCLC) by mediastinoscopy, mediastinotomy, thoracotomy, video-assisted thoracic surgery, or needle biopsy
  • Stage IIIA (N2) disease by chest CT scan
  • Any histologic subtype allowed



• At least 1 unidimensionally or bidimensionally measurable target lesion on chest CT scan



• No N3 or metastatic disease by physical exam, CT scan of thorax, bone scan, and CT scan or ultrasound of liver and adrenals



• No pre-existing pleural or pericardial effusion



• No symptomatic CNS involvement

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for NSCLC

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for NSCLC

Surgery:

• No prior surgery for NSCLC

Other:

• No other prior therapy for NSCLC

Patient Characteristics:

Age:

• Over 18

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No superior vena cava syndrome

Pulmonary:

• No diffuse interstitial pulmonary fibrosis

Other:

• No prior melanoma, breast cancer, or hypernephroma
• No other primary malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
• No grade 2 or greater pre-existing motor or sensory neurotoxicity
• No active uncontrolled infection requiring IV antibiotics
• Must be physically and mentally fit for study therapy
• No psychological, familial, sociological, or geographical condition that would preclude study compliance
• Not pregnant or nursing
• Fertile patients must use effective contraception

Expected Enrollment

A total of 640 patients will be accrued for this study within 8 years.

Outline

This is a randomized, multicenter study. Patients are stratified according to participating center, response to induction chemotherapy (complete vs partial vs minor), and histological subtype (squamous vs nonsquamous).

All patients receive 3 courses of induction combination chemotherapy comprising cisplatin or carboplatin in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response (or minor response if disease has become resectable) are randomized to 1 of 2 treatment arms.

• Arm I: Within 6 weeks of randomization, patients undergo radical lobectomy or pneumonectomy plus dissection of the hilar and mediastinal lymph nodes.

  Patients with positive resection margins of at least 1 cm and/or positive mediastinal nodes undergo radiotherapy 5 days a week for 5.5 weeks.

  Patients with postresection subclinical/microscopic disease with negative tumor margins undergo radiotherapy 5 days a week for 4-4.5 weeks.




• Arm II: Within 6 weeks of randomization, patients undergo primary radiotherapy.

  Patients with subclinical/microscopic disease with negative tumor margins undergo radiotherapy 5 days a week for 4-4.5 weeks.

  Patients with gross tumor volume and tumor margins at least 1 cm undergo radiotherapy 5 days a week for 6 weeks.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

van Meerbeeck JP, Kramer GW, Van Schil PE, et al.: Randomized controlled trial of resection versus radiotherapy after induction chemotherapy in stage IIIA-N2 non-small-cell lung cancer. J Natl Cancer Inst 99 (6): 442-50, 2007.[PUBMED Abstract]

Kramer GW, Legrand CL, van Schil P, et al.: Quality assurance of thoracic radiotherapy in EORTC 08941: a randomised trial of surgery versus thoracic radiotherapy in patients with stage IIIA non-small-cell lung cancer (NSCLC) after response to induction chemotherapy. Eur J Cancer 42 (10): 1391-8, 2006.[PUBMED Abstract]

Van Meerbeeck JP, Kramer GW, Legrand C, et al.: Does downstaging in patients (pts) with IIIA-N2 non-small cell lung cancer (NSCLC) and a response to induction chemotherapy (ICT) influence outcome with surgery (S) or radiotherapy (RT)? An exploratory analysis of EORTC 08941. [Abstract] J Clin Oncol 24 (Suppl 18): A-7047, 375s, 2006.

Van Meerbeeck JP, Kramer G, Van Schil PE, et al.: A randomized trial of radical surgery (S) versus thoracic radiotherapy (TRT) in patients (pts) with stage IIIA-N2 non-small cell lung cancer (NSCLC) after response to induction chemotherapy (ICT) (EORTC 08941). [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA7015, 624s, 2005.

Van Schil P, Van Meerbeeck J, Kramer G, et al.: Morbidity and mortality in the surgery arm of EORTC 08941 trial. Eur Respir J 26 (2): 192-7, 2005.[PUBMED Abstract]

van Meerbeeck JP, Kramer GWPM, van Schil PEY, et al.: Induction chemotherapy (CT) in stage IIIA-N2 non-small cell lung cancer (NSCLC):an analysis of different regimens used in EORTC 08941. [Abstract] Lung Cancer 41 (Suppl 2): A-O-273, S79, 2003.

van Schil PE, van Meerbeeck JP, Kramer G, et al.: Surgery after induction chemotherapy: morbidity and mortality in the first 100 patients of the surgery arm of EORTC 08941 trial. [Abstract] Lung Cancer 41 (Suppl 2): A-O-147, S45, 2003.

Splinter TA, Kirkpatrick A, Van Meerbeeck J, et al.: Randomized trial of surgery versus radiotherapy in patients with stage IIIA non-small cell lung cancer after a response to induction chemotherapy. Intergroup study 08941. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1742, 453a, 1998.

Van Meerbeeck JP, De Pauw R, Tournoy K: What is the optimal treatment of stage IIIA-N2 non-small-cell lung cancer after EORTC 08941? Expert Rev Anticancer Ther 8 (2): 199-206, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Ted Splinter, MD, Protocol chair(Contact information may not be current)		Ph: 31-10-463-4897

Registry Information
Official Title		RANDOMIZED TRIAL OF SURGERY VERSUS RADIOTHERAPY IN PATIENTS WITH STAGE IIIa NON-SMALL CELL LUNG CANCER AFTER A RESPONSE TO INDUCTION-CHEMOTHERAPY
Trial Start Date		1994-12-01
Registered in ClinicalTrials.gov		NCT00002623
Date Submitted to PDQ		1994-12-01
Information Last Verified		2002-05-06

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