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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893035
• Other study ID #: PHRC 2005 DA
• Status: Completed
• Start date: June 2006
• Est. completion date: October 29, 2019

Study information

• Verified date: November 2022
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 885
• Est. completion date: October 29, 2019
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
France	CRLC Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late complications		2 years