RANDOMIZED TRIAL OF SURGERY VERSUS RADIOTHERAPY IN PATIENTS WITH STAGE IIIa NON-SMALL CELL LUNG CANCER AFTER A RESPONSE TO INDUCTION-CHEMOTHERAPY


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

RANDOMIZED TRIAL OF SURGERY VERSUS RADIOTHERAPY IN PATIENTS WITH STAGE IIIa NON-SMALL CELL LUNG CANCER AFTER A RESPONSE TO INDUCTION-CHEMOTHERAPY


OBJECTIVES:

- 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.

- Compare the progression-free survival of patients treated with these regimens.

- Compare the toxic effects of these regimens in these patients.

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.

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

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Ted A.W. Splinter, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Medical Center Rotterdam at Erasmus Medical Center

Authority:

United States: Federal Government

Study ID:

EORTC-08941

NCT ID:

NCT00002623

Start Date:

December 1994

Completion Date:

Related Keywords:

  • Lung Cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIA non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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