NCT00893035已完成不适用
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 人开始时间: 2006年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 885
- 试验地点
- 1
- 主要终点
- Late complications
研究概览
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Patient aged > 18 and < 80
- •Patient affiliated with social security
- •Written informed consent, dated and signed
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)
- •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 N
- •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
研究组 & 干预措施
Intermediate prognosis prostate cancer
Intermediate prognosis prostate cancer
Breast cancer
conservative treatment and age<60 Boost irradiation and age>60
结局指标
主要结局
Late complications
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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