Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors (NCT00875004) | Clinical Trial Compass
TerminatedNot Applicable
Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors
Stopped: After two years of trial initiation, only 27 out of 300 patients were included. During this period, the international recommendations for the use of COOL were modified.
France27 participantsStarted 2007-12-07
Plain-language summary
RATIONALE: Epoetin beta may cause the body to make more red blood cells and may prevent or reduce side effects in patients undergoing chemotherapy for solid tumors.
PURPOSE: This clinical trial is studying how well epoetin beta works in patients undergoing chemotherapy for solid tumors.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria :
* Age \> 18 years
* Hemoglobin levels between \[ \> 9g/dl - \< 11 g/dl \] .
* Patient requiring erythropoietine beta treatment for a foreseeable duration of at least 8 weeks under the same chemotherapy protocol.
* Patient with cancer undergoing chemotherapy
* Patient without EPO within 6 months prior to current chemotherapy.
* WHO 2 performance status (Appendix 1).
* Patient information and signature of informed consent or legal representative
Exclusion criteria :
* Hemoglobin \< 9 g/dl or \> 11 g/dl
* Patient with cancer not treated with chemotherapy (targeted therapy, hormone therapy, etc…)
* Patient with cancer treated with concomitant radiation chemotherapy.
* Co-treated with Epo beta and scheduled transfusion prior to inclusion.
* Hypersensitivity to the active substance or one of the NeoRecormon excipients®
* Poorly controlled high blood pressure
* Pregnant woman, likely to be pregnant or breastfeeding,
* Persons deprived of liberty or under guardianship,
* Unable to undergo medical follow-up for geographic, social or psychological reasons.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment failure (changes in hemoglobin levels)
Timeframe: From date of randomization until the week 8
Trial details
NCT IDNCT00875004
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle