Concomitant Radio-chemotherapy in the Elderly

NCT01029678 | Completed Phase 2 DMC

• 1 other identifier: I08011
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Non Small Cell Lung Cancer

Keywords

Locally advanced lung cancer; Elderly patients; NSCLC

Outcome Measures

Primary Outcomes (1)

• Acute toxicity

  during treatment and during the 4 weeks following the end of treatment

Secondary Outcomes (2)

• Late toxicity

  6 months after the end of the treatment

• Overall response rate

  4 weeks after treatment

Study Arms (1)

experimental

EXPERIMENTAL

Drug: Cisplatin IV; Drug: Vinorelbine; Radiation: Radiotherapy

Interventions

Cisplatin IV DRUG

Cisplatin IV 30 mg/m2/ (Day 1, Day 8, Day 15, Day 22, Day 29, Day 36)

experimental

Vinorelbine DRUG

Vinorelbine per os 30 mg/m2/(day1, day8, day15, day22, day29, day36

experimental

Radiotherapy RADIATION

66Gy, 33 fractions, 6 week

experimental

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead
• Pierre Fabre Laboratories: collaborator

Study Sites (5)

CHU Brest

Brest, France

Location

Centre Hospitalier GAP

Gap, France

Location

Département de Pathologie Respiratoire du CHU de Limoges

Limoges, France

Location

CH de Meaux

Meaux, France

Location

CHU Reims

Reims, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Vinorelbine; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• Chrystèle LOCHER, MD

  CH Meaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 10, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2016
• Last Updated: May 3, 2018

Record last verified: 2018-01

Locations

FR (5)