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Concomitant Radio-chemotherapy in the Elderly (RACCOSA)

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ClinicalTrials.gov Identifier: NCT01029678
Recruitment Status : Unknown
Verified March 2015 by University Hospital, Limoges.
Recruitment status was:  Active, not recruiting
First Posted : December 10, 2009
Last Update Posted : March 10, 2015
Sponsor:
Collaborator:
Pierre Fabre Laboratories
Information provided by (Responsible Party):
University Hospital, Limoges

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Actual Primary Completion Date : January 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Acute toxicity [ Time Frame: during treatment and during the 4 weeks following the end of treatment ]

Secondary Outcome Measures :
  1. Late toxicity [ Time Frame: 6 months after the end of the treatment ]
  2. Overall response rate [ Time Frame: 4 weeks after treatment ]


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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029678


Locations
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, France
Sponsors and Collaborators
University Hospital, Limoges
Pierre Fabre Laboratories
Investigators
Study Chair: Chrystèle LOCHER, MD CH Meaux

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01029678     History of Changes
Other Study ID Numbers: I08011
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015

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

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