Clinical trial NCT00893035: Evaluation of an Apoptotic Test for Predicting Late Toxicities After Radiotherapy in Breast and Prostate Cancer Patients
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Prostate Cancer
Keywords: Radiotherapy
Late side effects
Predictive assay
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2009-05-05
Enrollment: 885
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated in a cancer center

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.

Eligibility 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

Primary outcomes:
measure: Late complications
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CRLC Val d'Aurelle
Study officials:
affiliation: CRLC Val d'Aurelle
name: David Azria
role: PRINCIPAL_INVESTIGATOR
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