Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: cisplatin Procedure: conventional surgery Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
| Estimated Enrollment: | 640 |
| Study Start Date: | December 1994 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Belgium | |
| Algemeen Ziekenhuis Middelheim | |
| Antwerp, Belgium, 2020 | |
| A.Z. St. Jan | |
| Brugge, Belgium, 8000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Hopital de Jolimont | |
| Haine Saint Paul, Belgium, 7100 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| CHR - Clinique Saint Joseph - Hopital de Warqueguies | |
| Mons, Belgium, B-7000 | |
| Clinique Universitaire De Mont-Godinne | |
| Mont-Godinne Yvoir, Belgium, 5530 | |
| Stedelijk Ziekenhuis | |
| Roesclare, Belgium, 8800 | |
| France | |
| Academisch Ziekenhuis Utrecht | |
| Vandoeuvre-les-Nancy, France, 54511 | |
| Italy | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa (Genova), Italy, 16132 | |
| Netherlands | |
| Groot Ziekengasthuis 's-Hertogenbosch | |
| 's-Hertogenbosch, Netherlands, 5211 NL | |
| Vrije Universiteit Medisch Centrum | |
| Amsterdam, Netherlands, 1001HV | |
| Antoni van Leeuwenhoekhuis | |
| Amsterdam, Netherlands, 1066 CX | |
| Arnhems Radiotherapeutisch Instituut | |
| Arnhem, Netherlands, 6815 AD | |
| Ziekenhuis St Jansdal | |
| Harderwijk, Netherlands, 3840 AC | |
| Atrium Medical Centre | |
| Heerlen, Netherlands, 6419 PC | |
| Elkerliek Ziekenhuis | |
| Helmond, Netherlands, 5707-HA | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 CA | |
| Sint Antonius Ziekenhuis | |
| Nieuwegein, Netherlands, 3435 CM | |
| Canisius-Wilhelmina Ziekenhuis | |
| Nijmegen, Netherlands, 6532 SZ | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Saint Franciscus Ziekenhuis | |
| Roosendaal, Netherlands, 4708 AE | |
| University Hospital - Rotterdam Dijkzigt | |
| Rotterdam, Netherlands, 3000 CA | |
| Erasmus Medical Center | |
| Rotterdam, Netherlands, 3075 EA | |
| Twee Steden Ziekenhuis Vestiging Tilburg | |
| Tilburg, Netherlands, 5042 AD | |
| Diakonessenhuis Utrecht | |
| Utrecht, Netherlands, 3508 TG | |
| Sophia Ziekehuis | |
| Zwolle, Netherlands, 8000 GK | |
| United Kingdom | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Royal Victoria Hospital | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BA | |
| Study Chair: | Ted A.W. Splinter, MD | University Medical Center Rotterdam at Erasmus Medical Center |
More Information
Additional Information:
Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00002623 History of Changes |
| Other Study ID Numbers: | EORTC-08941, EORTC-08941 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 29, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
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 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Cisplatin Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013