|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Institut Gustave Roussy |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002858 |
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 more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for small cell lung cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy using two different doses of cyclophosphamide followed by alternating chemotherapy and radiation therapy in treating patients with small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER |
| Estimated Enrollment: | 280 |
| Study Start Date: | March 1993 |
OBJECTIVES: I. Compare the effect on 2-year disease-free survival of two different doses of cyclophosphamide as part of first induction chemotherapy followed by alternating chemotherapy and chest irradiation in patients with limited stage small cell lung cancer.
OUTLINE: This is a randomized study. Patients are stratified by participating institution. All patients receive 2 courses of induction chemotherapy with doxorubicin, etoposide, cisplatin, and cyclophosphamide. For the first course, one group of patients receives a lower dose of cyclophosphamide than the other group. Both groups receive the same, and still lower, dose of cyclophosphamide during the second course. Beginning 1 week after the completion of induction therapy, patients receive 3 alternating courses each of radiotherapy to the mediastinal and supraclavicular areas delivered over 10-12 days and chemotherapy as in the second course of induction. Each course is initiated after a 1-week rest. Patients receive a final chemotherapy course beginning 4 weeks after the previous chemotherapy course. Patients are followed every 6 months for survival.
PROJECTED ACCRUAL: A total of 280 patients will be entered.
Eligibility| Ages Eligible for Study: | up to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven small cell lung cancer with no distant metastases Size of initial lesion suitable for total irradiation Positive subclavicular nodes allowed No malignant pleural effusion No extension into contralateral lung
PATIENT CHARACTERISTICS: Age: Under 70 Performance status: Karnofsky 60%-100% Hematopoietic: WBC greater than 2,000 Platelets greater than 125,000 Hepatic: Not specified Renal: Creatinine less than 1.1 mg/dL (100 micromoles/L) Cardiovascular: No myocardial infarction within 6 months No other cardiovascular disease that precludes protocol treatment Other: No hearing loss No prior or concurrent malignancy except: Basal cell skin carcinoma In situ carcinoma of the cervix Accessible for follow-up
PRIOR CONCURRENT THERAPY: No prior chemotherapy, radiotherapy, or surgery
Contacts and Locations| France | |
| Centre Paul Papin | |
| Angers, France, 49036 | |
| Centre Hospitalier Regional et Universitaire d'Angers | |
| Angers, France, 49033 | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Centre Regional Francois Baclesse | |
| Caen, France, 14076 | |
| Hopital Antoine Beclere | |
| Clamart, France, 92141 | |
| Centre Hospitalier Sud Francilien - Site Corbeil | |
| Corbeil, France, 91100 | |
| Hopital Intercommunal De Creteil | |
| Creteil, France, 94010 | |
| Centre de Lute Contre le Cancer,Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| Hopital De La Trouhade | |
| Dijon, France, 21034 | |
| C.H. General Andre Boulloche | |
| Montbeliard, France, 25209 | |
| CRLCC Nantes - Atlantique | |
| Nantes-Saint Herblain, France, 44805 | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| Hopital Haut Leveque | |
| Pessac, France, 33604 | |
| C.H. De Saumur | |
| Saumur, France, 49403 | |
| Hopitaux Universitaire de Strasbourg | |
| Strasbourg, France, 67091 | |
| Institut Claudius Regaud | |
| Toulouse, France, 31052 | |
| Centre Alexis Vautrin | |
| Vandoeuvre-les-Nancy, France, 54511 | |
| CHRU de Nancy - Hopitaux de Brabois | |
| Vandoeuvre-Les-Nancy, France, 54511 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Study Chair: | Thierry L. Le Chevalier, MD | Institut Gustave Roussy |
More Information
| ClinicalTrials.gov Identifier: | NCT00002858 History of Changes |
| Other Study ID Numbers: | CDR0000065122, FRE-CPC014, EU-96009 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
|
limited stage small cell lung cancer |
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Cisplatin Cyclophosphamide Doxorubicin Etoposide |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Antibiotics, Antineoplastic Antineoplastic Agents, Phytogenic |
