Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2010-01-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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experimental
Cisplatin IV
Cisplatin IV 30 mg/m2/ (Day 1, Day 8, Day 15, Day 22, Day 29, Day 36)
Vinorelbine
Vinorelbine per os 30 mg/m2/(day1, day8, day15, day22, day29, day36
Radiotherapy
66Gy, 33 fractions, 6 week
Interventions
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Cisplatin IV
Cisplatin IV 30 mg/m2/ (Day 1, Day 8, Day 15, Day 22, Day 29, Day 36)
Vinorelbine
Vinorelbine per os 30 mg/m2/(day1, day8, day15, day22, day29, day36
Radiotherapy
66Gy, 33 fractions, 6 week
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
ALL
No
Sponsors
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Pierre Fabre Laboratories
INDUSTRY
University Hospital, Limoges
OTHER
Responsible Party
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Principal Investigators
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Chrystèle LOCHER, MD
Role: STUDY_CHAIR
CH Meaux
Locations
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CHU Brest
Brest, , France
Centre Hospitalier GAP
Gap, , France
Département de Pathologie Respiratoire du CHU de Limoges
Limoges, , France
CH de Meaux
Meaux, , France
CHU Reims
Reims, , France
Countries
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Other Identifiers
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I08011
Identifier Type: -
Identifier Source: org_study_id
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