Concomitant Radio-chemotherapy in the Elderly

Non Small Cell Lung Cancer Clinical Trial

— RACCOSA  

Official title:

Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029678
• Other study ID #: I08011
• Status: Completed
• Phase: Phase 2
• Start date: January 2010
• Est. completion date: June 2016

Study information

• Verified date: January 2018
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• 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

Radiation:
• Radiotherapy
66Gy, 33 fractions, 6 week

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Pierre Fabre Laboratories

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicity		during treatment and during the 4 weeks following the end of treatment
Secondary	Late toxicity		6 months after the end of the treatment
Secondary	Overall response rate		4 weeks after treatment