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

NCT00893035 | Completed DMC

• 1 other identifier: PHRC 2005 DA
• Study Type: observational
• Target: 885
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the prediction of late toxicity by the radiation induced CD8 T-lymphocyte apoptosis

Conditions

Breast Cancer; Prostate Cancer

Keywords

Radiotherapy; Late side effects; Predictive assay

Outcome Measures

Primary Outcomes (1)

• Late complications

  2 years

Study Arms (2)

Intermediate prognosis prostate cancer

Intermediate prognosis prostate cancer

Breast cancer

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients treated in a cancer center

You may qualify if:

• 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

You may not qualify if:

• 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
• Breast Conservative surgery
• Non metastatic, M0
• negative surgical margins
• T1, T2; negative sentinel lymph node N0, N1 or N2.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

CRLC Val d'Aurelle

Montpellier, 34000, France

Location

Related Publications (41)

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MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• David Azria

  CRLC Val d'Aurelle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 5, 2009
• Study Start: June 1, 2006
• Primary Completion: December 1, 2015
• Study Completion: October 29, 2019
• Last Updated: February 5, 2026

Record last verified: 2022-11

Locations

FR (1)