Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer (PAL-ANGI)

March 12, 2026 updated by: Centre Oscar Lambret

A Phase II Randomized Study to Assess the Benefit of a Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative Cancer

The scope of the trial is to assess the free progression rate at 2 months for each group of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France, 59020
        • Hopital Saint Vincent
      • Lille, France, 59035
        • Centre Hospitalier Regional - Dermatology
      • Lille, France, 59035
        • Centre Hospitalier Regional - Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CYCLOPHOSPHAMIDE
Drug: CYCLOPHOSPHAMIDE
50 mg x 2 /day , per os, nonstop until disease progression or toxicity or patient decision
Active Comparator: MEGESTROL
Drug: MEGESTROL
320 mg/day, per os, 2 pills of 160 mg one time, nonstop until disease progression or toxicity or patient decision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival rate at 2 months
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival rate and objective response (RECIST) at 2, 4 and 6 months
Time Frame: After 2, 4 and 6 months of treatment
After 2, 4 and 6 months of treatment
Toxicity according to NCI scale v3.0
Time Frame: During study treatment
During study treatment
Biological markers
Time Frame: the 2 first months of treatment
the 2 first months of treatment
Overall survival
Time Frame: Until death of the patient or until study analysis
Until death of the patient or until study analysis
Median time between the beginning of treatment and hospitalization due to progression or toxicity
Time Frame: time of the study
time of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: PENEL Nicolas, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2009

Primary Completion (Actual)

January 19, 2011

Study Completion (Actual)

January 19, 2011

Study Registration Dates

First Submitted

January 9, 2007

First Submitted That Met QC Criteria

January 9, 2007

First Posted (Estimated)

January 11, 2007

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAL-ANGI-0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on CYCLOPHOSPHAMIDE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe