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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Centre Val d'Aurelle - Paul Lamarque
Sponsor:
Information provided by (Responsible Party):
Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier:
NCT00893035
First received: May 4, 2009
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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


Condition
Breast Cancer
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Centre Val d'Aurelle - Paul Lamarque:

Primary Outcome Measures:
  • Late complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 862
Study Start Date: June 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Intermediate prognosis prostate cancer
Intermediate prognosis prostate cancer
Breast cancer
conservative treatment and age<60 Boost irradiation and age>60

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients treated in a cancer center

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893035

Locations
France
CRLC Val d'Aurelle Recruiting
Montpellier, France, 34000
Contact: David Azria, Professor       david.azria@valdorel.fnclcc.fr   
Principal Investigator: David Azria, Professor         
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Investigators
Principal Investigator: David Azria CRLC Val d'Aurelle
  More Information

No publications provided

Responsible Party: Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier: NCT00893035     History of Changes
Other Study ID Numbers: PHRC 2005 DA
Study First Received: May 4, 2009
Last Updated: February 6, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Val d'Aurelle - Paul Lamarque:
Radiotherapy
Late side effects
Predictive assay

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 22, 2014