Evaluation of an Apoptotic Test for Predicting Late Toxicities After Radiotherapy in Breast and Prostate Cancer Patients

NCT ID: NCT00893035

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 885 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2019-10-29

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.

Conditions

Breast Cancer; Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intermediate prognosis prostate cancer

Intermediate prognosis prostate cancer

No interventions assigned to this group

Breast cancer

conservative treatment and age\<60 Boost irradiation and age\>60

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Azria

Role: PRINCIPAL_INVESTIGATOR

CRLC Val d'Aurelle

Locations

CRLC Val d'Aurelle

Montpellier, , France

Countries

France

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Other Identifiers

PHRC 2005 DA

Identifier Type: -

Identifier Source: org_study_id