Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.
- Conditions
- Non-small Cell Lung Cancer MetastaticNonsquamous Nonsmall Cell Neoplasm of Lung
- Interventions
- Registration Number
- NCT01705184
- Lead Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Brief Summary
At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression.
In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological.
The question is to know if this strategy is feasible in lung cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Non squamous non small cell lung cancer histologically or cytologically confirmed with no EGFR mutation.
- Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is asymptomatic.
- Measurable disease (recist criteria)
- Age ≥18 years
- PS0 or 1
- Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated cancer
- History of malignant tumour excepted cervical and basocellular cancer and cancer cured for at least 5 years.
- Tumor invaded the big vessels or the proximal visible in TDM.
- History of adjuvant or neoadjuvant chemotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BUCiL Pemetrexed Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --\> Sequence 2 Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control BUCiL Cisplatin Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --\> Sequence 2 Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control BUCiL Bevacizumab Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --\> Sequence 2 Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control
- Primary Outcome Measures
Name Time Method Feasibility After 3 cycles Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence
- Secondary Outcome Measures
Name Time Method Control rate after the 2nd sequence After 3 cycles Response rate after the 1st sequence After 3 cycles Overall survival 12 months Quality of life During Sequence 2 : at the beginning and after 3 cycles
Trial Locations
- Locations (12)
Caen - Centre François Baclesse
🇫🇷Caen, France
HCL - Lyon Sud (Pneumologie)
🇫🇷Pierre Bénite, France
CH du Mans
🇫🇷Le Mans, France
Hopital Tenon - Pneumologie
🇫🇷Paris, France
Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
🇫🇷Marseille, France
Avignon - Institut Sainte-Catherine
🇫🇷Avignon, France
Caen - CHU Côte de Nacre
🇫🇷Caen, France
Centre Hospitalier
🇫🇷Chauny, France
Mulhouse - CH
🇫🇷Mulhouse, France
Nantes - Centre René Gauducheau
🇫🇷Nantes, France
Rennes - CHU
🇫🇷Rennes, France
Strasbourg - NHC
🇫🇷Strasbourg, France