RANDOMISED CLINICAL TRIAL OF IFOSFAMIDE, CARBOPLATIN AND ETOPOSIDE WITH MID-CYCLE VINCRISTINE (VICE) VERSUS STANDARD PRACTICE CHEMOTHERAPY IN PATIENTS WITH LIMITED STAGE SMALL CELL LUNG CANCER (SCLC) AND GOOD PERFORMANCE STATUS
carboplatin
+ cisplatin
+ cyclophosphamide
Maladies pulmonaires+4
+ Néoplasmes
+ Néoplasmes par site
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mars 1996
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Compare the survival rate in patients with newly diagnosed small cell lung cancer and good performance status treated with an intensive regimen of ifosfamide/carboplatin/etoposide with mid-cycle vincristine (VICE) vs. standard chemotherapy followed, as feasible, by thoracic radiotherapy. Compare the adverse effects of treatment and quality of life (including psychological distress, physical status, and functional status and global quality of life) in these patients. Compare the Rotterdam Symptom Checklist vs. the EORTC QLQ-C30 and LC13 quality-of-life questionnaires in relation to compliance and ability to detect differences between treatments. OUTLINE: This is a randomized study. The first group receives standard combination chemotherapy with doxorubicin/cyclophosphamide/etoposide (ACE) or cisplatin/etoposide (PE) every 3 weeks for 6 courses. The second group receives intensive combination chemotherapy with carboplatin/ifosfamide/etoposide on days 1-3 with vincristine on day 14 (VICE). Courses repeat every 4 weeks for 6 courses. Patients in both groups are considered for thoracic radiotherapy beginning 4-5 weeks after the first day of the last course of chemotherapy. Concurrent prophylactic antibiotics should be given. Patients who relapse may receive further treatment at the clinician's option. Patients are followed monthly for 6 months, every 2 months for up to 1 year, every 3 months for up to 2 years, every 6 months for 5 years, and annually thereafter. PROJECTED ACCRUAL: A total of 400 patients will be entered over 3 years.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.400 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: Microscopically proven small cell lung cancer Diagnosis based on bronchial, mediastinal, pleural, lung, or lymph node biopsy, sputum cytology, or bronchial brushing or fine needle aspirate cytology No pleural fluid cytology No prior therapy PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Hematopoietic: WBC more than 3,000 ANC more than 1,500 Platelets more than 100,000 Hepatic/Renal: Alkaline phosphatase, aminotransferase, sodium, and LDH normal or no more than 1 of them abnormal Creatinine or urea normal Creatinine clearance or GFR more than 65 mL/min Other: No clinical evidence of infection No prior or concurrent malignancy that interferes with protocol treatments or comparisons No other condition that contraindicates treatment Willing and able to complete quality-of-life questionnaires Hospital Anxiety and Depression Scale, Rotterdam Symptom Checklist, and EORTC questionnaires completed prior to randomization PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Medical Research Council Clinical Trials Unit
London, United KingdomOuvrir Medical Research Council Clinical Trials Unit dans Google Maps