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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.


N/A
18 Years
80 Years
Open (Enrolling)
Both
Breast Cancer, Prostate Cancer

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Trial Information

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.


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.

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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Late complications

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

David Azria

Investigator Role:

Principal Investigator

Investigator Affiliation:

CRLC Val d'Aurelle

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

PHRC 2005 DA

NCT ID:

NCT00893035

Start Date:

June 2006

Completion Date:

December 2016

Related Keywords:

  • Breast Cancer
  • Prostate Cancer
  • Radiotherapy
  • Late side effects
  • Predictive assay
  • Breast Neoplasms
  • Prostatic Neoplasms

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