Concomitant Radio-chemotherapy in the Elderly (RACCOSA)

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

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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Cisplatin IV; Drug: Vinorelbine; Radiation: Radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Brest, France
    • CHU Brest
  • GAP, France
    • Centre Hospitalier GAP
  • Limoges, France
    • Département de Pathologie Respiratoire du CHU de Limoges
  • Meaux, France
    • CH de Meaux
  • Reims, France
    • Chu Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental	Drug: Cisplatin IV; Cisplatin IV 30 mg/m2/ (Day 1, Day 8, Day 15, Day 22, Day 29, Day 36); Drug: Vinorelbine; Vinorelbine per os 30 mg/m2/(day1, day8, day15, day22, day29, day36; Radiation: Radiotherapy; 66Gy, 33 fractions, 6 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acute toxicity	during treatment and during the 4 weeks following the end of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Late toxicity	6 months after the end of the treatment
Overall response rate	4 weeks after treatment

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Collaborators: Pierre Fabre Laboratories
• Investigators: Study Chair: Chrystèle LOCHER, MD, CH Meaux

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 9, 2009
• First Submitted That Met QC Criteria: December 9, 2009
• First Posted (Estimate): December 10, 2009

Study Record Updates

• Last Update Posted (Actual): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: NSCLC; Elderly patients; Locally advanced lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Cisplatin; Vinorelbine
• Other Study ID Numbers: I08011