Multicenter Prospective Evaluation of a Predictive Test of Late Toxicities After Radiotherapy by the Rate of Radiation Induced CD8 T-Lymphocyte Apoptosis: Application to Breast and Prostate Cancers.
Inclusion Criteria
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
Exclusion Criteria for breast cancer patients:
- Metastatic patients
- Bilateral breast cancer (concomitant or previous) except in situ
- T4 or N3 or treated by mastectomy
- Patients with chemotherapy or neoadjuvant hormonotherapy
- Patients with a previous other cancer within the last 5 years EXCEPT basocellular
carcinoma of the skin or in situ cancer of the uterus.
- Patients with another systemic disease (cardiovascular, renal, hepatic, pulmonary
embolism, etc.) non stabilised or generalised sclerodermia.
- Pregnant or breast feeding women
- 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