Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT00002623 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : July 2, 2012
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy followed by surgery with or without radiation therapy is more effective than chemotherapy followed by radiation therapy alone in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by surgery with or without radiation therapy to that of chemotherapy followed by radiation therapy alone in treating patients who have stage III non-small cell lung cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer | Drug: carboplatin Drug: cisplatin Procedure: conventional surgery Radiation: radiation therapy | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 640 participants |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| Official Title: | RANDOMIZED TRIAL OF SURGERY VERSUS RADIOTHERAPY IN PATIENTS WITH STAGE IIIa NON-SMALL CELL LUNG CANCER AFTER A RESPONSE TO INDUCTION-CHEMOTHERAPY |
| Study Start Date : | December 1994 |
| Actual Primary Completion Date : | December 2002 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002623
Show 30 study locations
| Study Chair: | Ted A.W. Splinter, MD | University Medical Center Rotterdam at Erasmus Medical Center |
Other Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00002623 |
| Other Study ID Numbers: |
EORTC-08941 EORTC-08941 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | July 2, 2012 |
| Last Verified: | June 2012 |
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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 |
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Carboplatin Antineoplastic Agents |