Combination Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Stage IIIB 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: etoposide Procedure: conventional surgery Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy |
| Enrollment: | 5 |
| Study Start Date: | April 2001 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the incidence of radically resected disease in patients with stage IIIB non-small cell lung cancer treated with induction cisplatin, etoposide, and radiotherapy followed by surgical resection.
- Determine the toxicity (morbidity and mortality) of this regimen in these patients.
- Determine the clinical response rate and pathological response rate in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3. Chemotherapy repeats every 3 weeks for 3 courses. Beginning on day 2 of the second course of chemotherapy, patients undergo induction radiotherapy once daily 5 days a week for 5-7 weeks. Chemoradiotherapy continues in the absence of disease progression or unacceptable toxicity.
At 3-6 weeks after completion of the last dose of induction radiotherapy, patients undergo lobectomy or pneumonectomy.
Patients are followed at 30 days and 4 months, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 27-62 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary stage IIIB non-small cell lung cancer (NSCLC)
- T4, any N, M0 or any T, N3, M0
- No N3 disease due to scalene or supraclavicular lymph node involvement
- No primary tumors located in the lower lobe combined with contralateral upper higher mediastinal lymph node involvement
- No mixed tumor types with small cell lung cancer
At least 1 unidimensionally measurable target lesion
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
- No pre-existing pleural or pericardial effusion
- No CNS involvement by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- WHO 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm ^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.25 times ULN
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No clinical evidence of superior vena cava syndrome
Pulmonary:
- Postoperative FEV1 and KCO greater than 40% predicted
- VO2 max greater than 15 mL/min/kg (if postoperative KCO no greater than 40% predicted)
Other:
- No other primary malignancy except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or other malignancy treated more than 5 years ago without recurrence (excluding melanoma, breast cancer, or hypernephroma)
- No active uncontrolled infection requiring IV antibiotics
- No pre-existing sensory neurotoxicity grade 2 or greater
- No psychological, familial, sociological, or geographical condition that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy for NSCLC
- No concurrent immunotherapy during induction chemoradiotherapy
- Concurrent colony stimulating factors allowed
Chemotherapy:
- No prior chemotherapy for NSCLC
Endocrine therapy:
- No concurrent anticancer hormonal agents (except corticosteroids for antiemetic prophylaxis) during induction chemoradiotherapy
Radiotherapy:
- No prior radiotherapy for NSCLC
Surgery:
- No prior surgery for NSCLC
Other:
- No other concurrent anticancer drugs during induction chemoradiotherapy
Contacts and Locations| Belgium | |
| Algemeen Ziekenhuis Middelheim | |
| Antwerp, Belgium, 2020 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Germany | |
| Thoraxklinik Rohrbach | |
| Heidelberg, Germany, D-69126 | |
| Netherlands | |
| Gelre Ziekenhuizen - Lokatie Lukas | |
| Apeldoorn, Netherlands, 7334 DZ | |
| Sint Antonius Ziekenhuis | |
| Nieuwegein, Netherlands, 3435 CM | |
| University Hospital - Rotterdam Dijkzigt | |
| Rotterdam, Netherlands, 3000 CA | |
| Rotterdam Cancer Institute | |
| Rotterdam, Netherlands, 3000 CA | |
| Academisch Ziekenhuis Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| Poland | |
| Medical University of Gdansk | |
| Gdansk, Poland, 80-211 | |
| National Institute of Tuberculosis and Lung Diseases | |
| Warsaw, Poland | |
| Study Chair: | Rob Van Klaveren, MD, PhD | University Medical Center Rotterdam at Erasmus Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00021112 History of Changes |
| Other Study ID Numbers: | EORTC-08981, EORTC-08981 |
| Study First Received: | July 11, 2001 |
| Last Updated: | July 17, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
stage IIIB non-small 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 Etoposide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013