Evaluation of an Apoptotic Test for Predicting Late Toxicities After Radiotherapy in Breast and P… (NCT00893035) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of an Apoptotic Test for Predicting Late Toxicities After Radiotherapy in Breast and Prostate Cancer Patients
France885 participantsStarted 2006-06
Plain-language summary
The primary objective of this study is to evaluate the prediction of late toxicity by the radiation induced CD8 T-lymphocyte apoptosis
Who can participate
Age range
18 Years – 80 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 for prostate cancer patients:
* localised prostate cancer, histologically proven
* Absence of metastases (M0) : normal bone scintigraphy
* Absence of radiological lymph node invasion (N0).
* Clinical Stage : T ≥ T1c-T2a and \< T3b Or T1b or c with PSA ≤ 10 ng/ml . Or T1b or c with Gleason ≥ 6
* PSA \< 30 ng/ml.
* Signs and symptoms according to NCI/CTC v3.0 \< grade 2
* ECOG Performance status ≤ 1
* Absence of hip prothesis
* Absence de endopenian stent
* Patient aged \> 18 and \< 80
* Patient affiliated with social security
* Written informed consent, dated and signed
Exclusion Criteria for prostate cancer patients:
* Antecedents of invasive cancer (unless if treated more than 5 years ago without evolution) except basocellular carcinoma
* positive biopsy of seminal vesicle
* PSA ≥ 30 ng/ml for two successive dosages
* Previous pelvic irradiation
* Previous radical prostatectomy for cancer
* Patients with another systemic disease (cardiovascular, renal, hepatic, pulmonary embolism, etc.) non stabilised or generalised sclerodermitis.
* Patients known to be HIV seropositive (no specific test is necessary for defining eligibility)
* Known homozygote ATM (Ataxy telangiectasy) mutation
* Impossibility for a correct follow up (for social family or geographical reasons)
* Patients incapable of providing consent, protected majors, vulnerable persons
* Patients participating in other clinical trials
Inclusion Criteria for breast cancer patients:
* Breast Conser…
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
Late complications
Timeframe: 2 years
Trial details
NCT IDNCT00893035
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle