Breast Cancer, Prostate Cancer
Conditions
Keywords
Radiotherapy, Late side effects, Predictive assay
Brief summary
The primary objective of this study is to evaluate the prediction of late toxicity by the radiation induced CD8 T-lymphocyte apoptosis
Detailed description
The two cancer sites concerned by this trial are intermediate risk prostate cancer treated with conformational radiotherapy with or without intensity modulation, and breast cancer patients treated with adjuvant radiotherapy after breast conservative surgery for patients aged under 60 years of age. The identification of 5% of patients at risk of severe toxicity should allow to deliver high dose radiotherapy among 95% of patients with a lower risk of severe late complications.
Interventions
None listed
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 Conservative surgery * Non metastatic, M0 * negative surgical margins * T1, T2; negative sentinel lymph node N0, N1 or N2. * Signs and symptoms according to NCI/CTC v3.0 \< grade 2 * Patient aged over 18 years and less than 60 or more than 60 with an indication for boost irradiation. * Patient affiliated with social security * Written informed consent, dated and signed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late complications | 2 years |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORDavid Azria
CRLC Val d'Aurelle
Outcome results
None listed