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.

Institut du Cancer de Montpellier - Val d'Aurelle1 个研究点分布在 1 个国家目标入组 885 人2006年6月1日

适应症Breast Cancer Prostate Cancer

概览

阶段: 不适用
干预措施: Intermediate prognosis prostate cancer
疾病 / 适应症: Breast Cancer
发起方: Institut du Cancer de Montpellier - Val d'Aurelle
入组人数: 885
试验地点: 1
主要终点: Late complications
状态: 已完成
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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

详细描述

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.

注册库

clinicaltrials.gov

开始日期

2006年6月1日

结束日期

2019年10月29日

最后更新

2个月前

研究类型

Observational

性别

All

研究者

发起方

Institut du Cancer de Montpellier - Val d'Aurelle

责任方

Sponsor

入排标准

入选标准

•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

排除标准

•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)