Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer
- Registration Number
- NCT00420563
- Lead Sponsor
- Centre Oscar Lambret
- Brief Summary
The scope of the trial is to assess the free progression rate at 2 months for each group of patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
- Age > or = 18
- PS-WHO < or = 1
- Histologically proven cancer
- No other therapeutic proposal
- Treatment can be orally taken
- Radiologic proof of evolutive character of the disease
- Effective contraception
Exclusion Criteria
- Hypercalcemia ( Ca > 2.65 mmol/l)
- Breast cancer
- Thrombosis or pulmonary embolism
- Dysphagia, malabsorption
- Polynuclear neutrophil leukocytes < 1000/mm3
- Treatment with Tegretol
- Active and uncontrolled infection
- Evolutive psychiatric disease
- Pregnant or lactating woman
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE - MEGESTROL MEGESTROL -
- Primary Outcome Measures
Name Time Method Progression free survival rate at 2 months 2 months
- Secondary Outcome Measures
Name Time Method Progression free survival rate and objective response (RECIST) at 2, 4 and 6 months After 2, 4 and 6 months of treatment Toxicity according to NCI scale v3.0 During study treatment Biological markers the 2 first months of treatment Overall survival Until death of the patient or until study analysis Median time between the beginning of treatment and hospitalization due to progression or toxicity time of the study
Trial Locations
- Locations (4)
Centre Hospitalier Regional - Dermatology
🇫🇷Lille, France
Centre Oscar Lambret
🇫🇷Lille, France
Hopital Saint Vincent
🇫🇷Lille, France
Centre Hospitalier Regional - Oncology
🇫🇷Lille, France