Lung Cancer Clinical Trial
Official title:
A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I, II, and Low Volume Stage III
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy used high-energy x-rays to damage tumor
cells. It is not yet know whether chemotherapy followed by radiation therapy is more
effective than chemotherapy given with radiation therapy for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens
of chemotherapy and radiation therapy in treating patients who have unresectable stage I,
stage II, or stage III non-small cell lung cancer.
Status | Terminated |
Enrollment | 158 |
Est. completion date | |
Est. primary completion date | March 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer - Stage I, II, III (T1-4, N0-3, M0) - No metastases to supraclavicular, contralateral hilar, or contralateral scalene lymph nodes - Medically inoperable or unresectable - No pleural or pericardial effusion (except with repeated negative cytology) PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0 or 1 Life expectancy: - Not specified Hematopoietic: - WBC at least 4,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 6.8 g/dL - No hemoptysis causing a decrease of hemoglobin of 1 g/dL or more within 24 hours Hepatic: - Not specified Renal: - Creatinine no greater than 1.25 times normal OR - Creatinine clearance greater than 70 mL/min Cardiovascular: - No evidence of heart failure - No myocardial infarction within the past 6 months - No superior vena cava syndrome Pulmonary: - FEV1 at least 1 L - No pre-existing fibrotic lung disease - No postobstructive pneumonia preventing exact delineation of tumor volume - Diffusion capacity at least 60% Other: - No weight loss of more than 10% in the past 3 months - No uncontrolled infection - No serious medical risk factors involving any of the major organ systems that would preclude adherence to the study treatment schedule PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunotherapy Chemotherapy: - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to the chest - Maximum length of the esophagus receiving 40 Gy no greater than 18 cm - Maximum length of the esophagus receiving 66 Gy no greater than 12 cm - Must limit the spinal cord dose to a maximum of 50 Gy - Must be able to exclude 25% of the heart from the boost volume Surgery: - Not specified Other: - No other concurrent experimental medications |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Algemeen Ziekenhuis Middelheim | Antwerp | |
Belgium | Hopital de Jolimont | Haine Saint Paul | |
France | CHR de Grenoble - La Tronche | Grenoble | |
Germany | Mutterhaus der Borromaerinnen | Trier | |
Netherlands | Medisch Centrum Haaglanden | 's-Gravenhage (Den Haag, The Hague) | |
Netherlands | Academisch Medisch Centrum | Amsterdam | |
Netherlands | Antoni van Leeuwenhoekhuis | Amsterdam | |
Netherlands | Gelre Ziekenhuizen - Lokatie Lukas | Apeldoorn | |
Netherlands | Amphia Ziekenhuis | Breda | |
Netherlands | Amphia Ziekenhuis - locatie Molengracht | Breda | |
Netherlands | Reinier de Graaf Group | Delft | |
Netherlands | Radiotherapeutisch Instituut-(Riso) | Deventer | |
Netherlands | Catharina Ziekenhuis | Eindhoven | |
Netherlands | Dr. Bernard Verbeeten Instituut | Tilburg | |
Netherlands | Twee Steden Ziekenhuis Vestiging Tilburg | Tilburg | |
Netherlands | Sophia Ziekehuis | Zwolle | |
United Kingdom | Western General Hospital | Edinburgh | Scotland |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
Belgium, France, Germany, Netherlands, United Kingdom,
Belderbos J, Uitterhoeve L, van Zandwijk N, Belderbos H, Rodrigus P, van de Vaart P, Price A, van Walree N, Legrand C, Dussenne S, Bartelink H, Giaccone G, Koning C; EORTC LCG and RT Group. Randomised trial of sequential versus concurrent chemo-radiothera — View Citation
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