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Concomitant Radio-chemotherapy in the Elderly (RACCOSA)

This study is currently recruiting participants.
Verified February 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: February 27, 2013
Last verified: February 2013
History of Changes

December 9, 2009
February 27, 2013
January 2010
January 2014   (final data collection date for primary outcome measure)
Acute toxicity [ Time Frame: during treatment and during the 4 weeks following the end of treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01029678 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Concomitant Radio-chemotherapy in the Elderly
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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • 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
Experimental: experimental
Interventions:
  • Drug: Cisplatin IV
  • Drug: Vinorelbine
  • Radiation: Radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
59
January 2015
January 2014   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
Contact: Chrystèle LOCHER, MD 01 64 35 38 56 ch-locher@ch-meaux.fr
France
 
NCT01029678
I08011
Yes
University Hospital, Limoges
University Hospital, Limoges
Pierre Fabre Laboratories
Study Chair: Chrystèle LOCHER, MD CH Meaux
University Hospital, Limoges
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP