This trial is active, not recruiting.

Condition non small cell lung cancer
Treatments cisplatin iv, vinorelbine, radiotherapy
Phase phase 2
Sponsor University Hospital, Limoges
Collaborator Pierre Fabre Laboratories
Start date January 2010
End date January 2015
Trial size 59 participants
Trial identifier NCT01029678, I08011


The purpose of this study is to evaluate the safety of non small cell lung cancer (NSCLC) treatment with cisplatin and oral vinorelbine administered weekly associated with concomitant radiotherapy in elderly patients.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
cisplatin iv
Cisplatin IV 30 mg/m2/ (Day 1, Day 8, Day 15, Day 22, Day 29, Day 36)
Vinorelbine per os 30 mg/m2/(day1, day8, day15, day22, day29, day36
66Gy, 33 fractions, 6 week

Primary Outcomes

Acute toxicity
time frame: during treatment and during the 4 weeks following the end of treatment

Secondary Outcomes

Late toxicity
time frame: 6 months after the end of the treatment
Overall response rate
time frame: 4 weeks after treatment

Eligibility Criteria

Male or female participants at least 70 years old.

Inclusion Criteria: - Age ≥ 70 years - Independent patients (based on the score of geriatric frailty: IADL = 0, ADL = 0, no geriatric syndrome, low comorbidity (comorbidity index of Charlson to 3 or 4), depression score 0-1) - Performance Status (ECOG) ≤ 1 - Weight loss <10% of usual weight in the last 3 months - Life expectancy greater than 12 weeks - Hematologic function: neutrophils> 1.5 x 10**9 / l, hemoglobin> 9.5 g / dl, platelets > 100 x 10**9 / l) - Renal function: creatinine clearance ≥ 50 ml / min calculated by the formula of MDRD - Normal liver function: bilirubin < Limit of Normal (ULN), SGOT and / or SGPT <2.5 x UNL - Respiratory Function: FEV ≥ 40% predicted, PaO2 ≥ 60 mm Hg, KCO ≥ 60% predicted - Patient affiliated to a social security regimen or beneficiary of such regimen - Informed consent signed The disease - Pathological anatomy: CBP non-small cell (squamous cell carcinoma, adenocarcinoma, large cell carcinoma, undifferentiated carcinoma) histologically or cytologically proven - Stage IIIAN2 considered inoperable stage IIIB - Presence of at least one measurable target - Delay at least three weeks between surgery and initiation of treatment - No prior treatment with chemotherapy or radiotherapy for lung cancer Exclusion Criteria: - Age < 70 years - Performance Status (ECOG) ≥ 2 - Hematologic function: neutrophils <1.5 x 10**9 / l, hemoglobin <9.5 g / dl, platelets <100 x 10**9 / l) - Renal function: creatinine clearance <50 ml / min calculated by the formula of MDRD - Hepatic: bilirubin> Upper Limit of Normal (ULN), SGOT and / or SGPT> 2.5 x ULN - Respiratory Function: FEV <40% predicted, KCO <60% predicted, PaO2 <60 mmHg - Peripheral neuropathy grade> 1 - Unstable cardiac pathology requiring treatment (heart failure, angor of effort, arrhythmia) or previous myocardial infarction older than 12 months - Deafness not paired or deafness requiring major achievement of an audiogram-cons may indicate taking cisplatin - Neurological or psychiatric disorders prohibiting the understanding of the test - Previous history of cancer except basal cell cancer, carcinoma in situ of the cervix treated or any other cancer treated with surgery alone or radiotherapy alone extra-thoracic recurrence-free 5 years - Significant malabsorption syndrome or disease affecting the functioning of the gastrointestinal tract The disease - Pathological anatomy: Bronchioloalveolar carcinoma, neuroendocrine carcinoma, small cell carcinoma - Metastatic disease - Pleural drain - Carcinomatous lymphangitis - Operable Cancer - Previously treated for lung cancer disease: radiotherapy, chemotherapy, hormonal therapy, endobronchial suctioning older less than eight days

Additional Information

Official title Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by University Hospital, Limoges.