Concomitant Radio-chemotherapy in the Elderly (RACCOSA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University Hospital, Limoges
Sponsor:
Collaborator:
Pierre Fabre Laboratories
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01029678
First received: December 9, 2009
Last updated: July 14, 2014
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Cisplatin IV
Drug: Vinorelbine
Radiation: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Acute toxicity [ Time Frame: during treatment and during the 4 weeks following the end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Late toxicity [ Time Frame: 6 months after the end of the treatment ] [ Designated as safety issue: Yes ]
  • Overall response rate [ Time Frame: 4 weeks after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 59
Study Start Date: January 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029678

Contacts
Contact: Chrystèle LOCHER, MD 01 64 35 38 56 ch-locher@ch-meaux.fr

Locations
France
CHU Brest Recruiting
Brest, France
Contact: G. ROBINET, MD         
Principal Investigator: G ROBINET, MD         
Centre Hospitalier GAP Recruiting
GAP, France
Principal Investigator: P. THOMAS, MD         
Département de Pathologie Respiratoire du CHU de Limoges Recruiting
Limoges, France
Principal Investigator: Aain VERGNENEGRE, MD         
CH de Meaux Recruiting
Meaux, France
Principal Investigator: Chrystèle LOCHER, MD         
CHU Reims Recruiting
Reims, France
Contact: F LEBARGY, MD         
Principal Investigator: F LEBARGY, MD         
Sponsors and Collaborators
University Hospital, Limoges
Pierre Fabre Laboratories
Investigators
Study Chair: Chrystèle LOCHER, MD CH Meaux
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01029678     History of Changes
Other Study ID Numbers: I08011
Study First Received: December 9, 2009
Last Updated: July 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
Locally advanced lung cancer
Elderly patients
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 16, 2014