Concomitant Radio-chemotherapy in the Elderly (RACCOSA)
This study is currently recruiting participants.
Verified February 2013 by University Hospital, Limoges
Sponsor:
University Hospital, Limoges
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
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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: | January 2015 |
| Estimated Primary Completion Date: | January 2014 (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
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: | February 27, 2013 |
| 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 Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 17, 2013