{"registry": "ISRCTN", "registryId": "ISRCTN95053737", "source": "https://www.isrctn.com/ISRCTN95053737", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN95053737/format/default", "fetchedAt": "2026-10-07T17:00:19.132742Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "A prospective randomized study of adjuvant chemotherapy with navelbine and cisplatin in completely resected non small cell lung cancer", "scientificTitle": "", "acronym": "ANITA 01", "hypothesis": "Whether adjuvant chemotherapy improves survival of patients with non-small-cell lung cancer (NSCLC) is not known. We aimed to compare the effect of adjuvant vinorelbine plus cisplatin versus observation on survival in patients with completely resected NSCLC.", "primaryOutcome": "Primary endpoint is overall survival, one-sided test, alpha = 0.05, beta = 0.10, delta = 10%, anticipated two-year survival rate is 30%, benefit expected is an absolute improvement of 10% in the two-year survival rate.", "secondaryOutcome": "1. To determine disease-free survival\n2. To evaluate toxicity related to chemotherapy", "intervention": "\n\tChemotherapy with navelbine and cisplatin versus best supportive care.\n\tDrug\n\tNot Specified\n\tNavelbine, cisplatin\n      ", "condition": "\n\tNon small cell lung cancer\n\tCancer\n\tNon small cell lung cancer\n      ", "studyDesign": "Randomized, open, multicenter", "overallEndDate": "2000-12-29T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2011-08-31T00:00:00.000Z", "eligibility": {"inclusion": "1. Histologically proven primary non small cell lung cancer (NSCLC) (except bronchoalveolar carcinoma) stage I (T2N0 only), II, and IIIA according to the 1986 TNM classification\n2. Complete resection of the primary tumor (all margins free of disease)\n3. Age 18-75 years\n4. World Health Organization (WHO) performance status ≤2\n5. Adequate biological functions", "exclusion": "1. Patients with a history of concurrent malignancy (except adequately treated non-melanoma skin cancer or in situ cervical cancer)\n2. Previous treatment with adjuvant therapy", "ageRange": "Adult", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "1994-12-06T00:00:00.000Z", "recruitmentEnd": "2000-12-29T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "840", "totalFinalEnrolment": ""}, "countries": ["Argentina", "Austria", "Brazil", "Czech Republic", "France", "Greece", "Italy", "Lebanon", "Poland", "Portugal", "Slovakia", "South Africa", "Spain", "United States of America"], "locations": [{"name": "Chef du département d'Oncologie Médicale", "city": "St-Herblain Cedex", "state": "", "country": "France", "zip": "44805"}], "sponsors": [{"organisation": "Pierre Fabre Oncologie (France)", "sponsorType": "Research organisation", "rorId": "https://ror.org/04hdhz511"}], "funders": [{"name": "Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (france)"}]}, "studySha256": "3a800456be613697f5dd38e9ea0139c313aadea595eac2a6c6ca1821618e1c63"}