Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer
PAL-ANGI
A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer
1 other identifier
interventional
88
1 country
4
Brief Summary
The scope of the trial is to assess the free progression rate at 2 months for each group of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 cancer
Started Sep 2009
Shorter than P25 for phase_2 cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2007
CompletedStudy Start
First participant enrolled
September 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2011
CompletedMarch 16, 2026
March 1, 2026
1.3 years
January 9, 2007
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival rate at 2 months
2 months
Secondary Outcomes (5)
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
Study Arms (2)
CYCLOPHOSPHAMIDE
EXPERIMENTALMEGESTROL
ACTIVE COMPARATORInterventions
50 mg x 2 /day , per os, nonstop until disease progression or toxicity or patient decision
320 mg/day, per os, 2 pills of 160 mg one time, nonstop until disease progression or toxicity or patient decision
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Centre Oscar Lambret
Lille, 59020, France
Hopital Saint Vincent
Lille, 59020, France
Centre Hospitalier Regional - Dermatology
Lille, 59035, France
Centre Hospitalier Regional - Oncology
Lille, 59035, France
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
PENEL Nicolas, MD
Centre Oscar Lambret
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2007
First Posted
January 11, 2007
Study Start
September 25, 2009
Primary Completion
January 19, 2011
Study Completion
January 19, 2011
Last Updated
March 16, 2026
Record last verified: 2026-03