EUCTR2006-002772-17-ES进行中（未招募）不适用
Radioterapia externa postoperatoria combinada con tratamiento hormonal adyuvante y concomitante frente a la radioterapia externa postoperatoria como tratamiento único en el carcinoma de próstata estadio pT3a-b R0-1 N0M0 / pT2R1 N0M0 y con puntuación de Gleason 5-10. Estudio fase III.(Post-operative external radiotherapy combined with concomitant and adjuvant hormonal treatment versus post-operative external radiotherapy alone in pathological stage pT3a-b R0-1 N0M0 / pT2R1 N0M0, Gleason score 5-10 prostatic carcinoma. A Phase III study)
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 600 人开始时间: 2009年12月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •-Pacientes con estadio clínico cT1-2-3 a N0 M0 con cáncer de próstata (UICC TNM 2002) comprobado después de un estadiaje que incluya exploración física, radiografía de tórax, gammagrafía ósea, TC o RM abdomino-pélvica.
- •-PSA preoperatorio < de multiplicar por 5 el límite superior normal
- •-Prostatectomía: todas las técnicas permitidas ( retropúbica, laparoscópica o perineal)
- •Tras la prostatectomía:
- •-Gleason 5-10
- •-Estadio pT2R1 (margen positivo quirúrgico con una sección tumoral como mínimo de 2 mm) o pT3a-b ( márgenes negativos o positivos)
- •-Ganglios negativos (pN0) por muestra ganglionar o por linfadenectomía. Un estado ganglionar desconocido (pNx) no está permitido a no ser que el paciente tenga un cT1 con PSA menor de 10 y Gleason menor de 7 con biopsias positivas en menos del 50%, con un total de biopsias de cómo mínimo 12.
- •-PSA pos-op no detectable en los tres primeros meses tras cirugía
- •-Edad < 80 años
- •-PS OMS 0-1
- •-Hemograma normal dentro de las dos semanas previas a la aleatorización: Hemoglobina > 110 g/l, leucocitos > 3x10?9/l, plaquetas > 100 x 10?9/l
- •-Consentimiento informado por escrito antes de la aleatorización
- •(?Patients with clinical stage cT1-2-3a N0M0 prostate cancer (UICC TNM 2002) assessed after a preoperative work-up including physical examination, chest X ray, bone scan, CT-scan or MRI of the entire pelvis and abdomen.
- •?Pre-operative PSA ≤ 5 x upper limit of normal range.
- •?Presenting after radical prostatectomy (all techniques allowed: retropubic, laparoscopic or perineal) with
- •?Gleason score 5-10.
- •?Pathologic stage pT2R1 (positive surgical margins with at least a tumor trans-section higher than 2 mm) or pT3a-b (irrespective of margin status).
- •?Negative lymph node (LN) status (pN0) by LN sampling or LN dissection. Unknown pathological LN status (pNx, i.e., omission of LN sampling or LN dissection) is not allowed except for patients classified as cT1c with baseline PSA < 10ng/ml and Gleason score < 7 and positive core biopsies < 50%, provided the total number of random biopsies is at least 12.
- •?Undetectable post-operative PSA (PSA is below the detection level of the laboratory) within 3 months of surgery.
- •?Age ≤ 80 years.
- •?WHO performance status 0-1.
- •?Normal organ functions as shown by all of the following (measured within 2 weeks prior to randomization): hemoglobin ≥ 110 g/l, WBC ≥3 x 109/l, platelet count ≥ 100 x 109/l.
- •?Before randomization, written informed consent must be given by the patient, according to ICH/GCP, and national/local regulations.)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-RT previa ò orquiectomía previa
- •-Quimioterapia previa en los últimos 5 años
- •-Tratamiento hormonal previo excepto neoadyuvante < 3 meses
- •-Otras neoplasias excepto carcinoma basocelular de la piel u otras sin evidencia de enfermedad en los últimos 5 años.
- •-Trastorno psico social, familiar, sicológico o geográfico que impidan cumplir bien el protocolo o el seguimiento.
- •(?Prior pelvic irradiation, prior bilateral orchiectomy.
- •?Prior chemotherapy within the 5 years prior to randomization.
- •?Prior hormonal treatment except neoadjuvant and lasting ≤3 months.
- •?Other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease free for at least 5 years.
- •?Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.)
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