ACTRN12612000169842已完成未知
The assessment of New Radiation Oncology Technologies and treatments (ANROTAT) in Post Prostatectomy, Anal Cancal, Nasopharynx and Intact Prostate, Radiation Oncology Register Pilot (ARORP) TROG Research Project TRP11.B
Trans Tasman Radiation Oncology Group0 个研究点目标入组 90 人开始时间: 2012年2月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Post Prostatectomy;
- •- Patient has been provided with the Patient Information Sheet and has not opted-out of the ARORP.
- •- Prior RP for adenocarcinoma of the prostate.
- •- Histological confirmation of adenocarcinoma of the prostate with the Gleason score reported (RP specimen).
- •- Patients must have at least one of the following risk factors:
- •-Positive margins
- •-Extraprostatic extension (EPE) with or without seminal vesicle involvement (pT3a or pT3b)
- •- PSA nadir less than or equal to 1.0 ng/ml following RP
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0 – 1 prior to the course of RT that defines eligibility for the ARORP
- •- Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires
- •- 18 years or older
- •- Have received IMRT or 3DCRT RT Treatment
- •Anal Cancer;
- •- Patient has been provided with the Patient Information Sheet and has not opted-out of the ARORP.
- •- Age 18-80 years of age
- •- Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires
- •- Histological confirmation of squamous cell carcinoma or basaloid carcinoma prior to the course of RT that defines eligibility for the ARORP
- •- T2-4N0, TanyN2 (ipsilateral groin nodes) and TanyN3 (bilateral groin nodes).
- •- Have received IMRT or 3DCRT RT Treatment
- •Nasopharynx;
- •- Patient has been provided with the Patient Information Sheet and has not opted-out of the ARORP.
- •- Age 18 years or older
- •- Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires
- •- Histologically confirmed carcinoma of the nasopharynx, types WHO1-111, Stage I-IVB prior to the course of RT that defines eligibility for the ARORP
- •- Adequate staging of local disease (MRI of primary must be performed, imaging of neck nodes with CT with contrast and/or PET-CT) and exclusion of distant metastatic disease (to be confirmed by either whole body PET-CT or a chest CT, and upper abdominal CT or ultrasound scan for patients with abnormal liver function tests or a bone scan or FDG-PET for patients with bone pain) prior to the course of RT that defines eligibility for the ARORP
- •- Disease must have been considered potentially curable by chemoradiation prior to the course of RT that defines eligibility for the ARORP
- •- Performance status ECOG 0, 1 or 2 prior to the course of RT that defines eligibility for the ARORP
- •- Have received IMRT or 3DCRT RT Treatment
- •Intact Prostate;
- •- Patient has been provided with the Patient Information Sheet and has not opted-out of the ARORP.
- •- Aged 18 years or older
- •- Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires
- •- Histological diagnosis of carcinoma of the prostate less than or equal to 6 months prior to the course of RT that defines eligibility for the ARORP without evidence of metastatic disease to the lymph nodes, bone or lung
- •- Intermediate risk prostate cancer (that is, T1-2a, Gleason score less than or equal to 6, PSA 10.1-20.0 ng/ml; T2b-c, Gleason less than or equal to 6, PSA less than or equal to 20.0 ng/ml; T1-2, Gleason 7, PSA less than or equal to 20.0 ng/ ml)
- •- Have received IMRT or 3DCRT RT Treatment
排除标准
- •Post Prostatectomy;
- •- Previous pelvic RT or surgery ie previous rectal or bladder resection prior to the course of RT that defines eligibility for the ARORP
- •- Concurrent malignancy within 5 years prior to registration (except non-melanomatous skin cancer)
- •- Androgen deprivation (AD) prior to or following RP as this will affect QoL
- •- Hip prosthesis prior to the course of RT that defines eligibility for the ARORP
- •Anal Cancer;
- •- Pelvic RT/ surgery (e.g. vaginal hysterectomy) prior to the course of RT that defines eligibility for the ARORP
- •- Presence of hip prosthesis prior to the course of RT that defines eligibility for the ARORP
- •- Acquired immunodeficiency syndrome (AIDS). HIV patients without AIDS eligible.
- •- Previous pelvic cancers prior to the course of RT that defines eligibility for the ARORP
- •Nasopharynx;
- •- Previous head and neck RT or major surgery prior to the course of RT that defines eligibility for the ARORP
- •- Chemotherapy less than or equal to 6 months from study entry prior to the course of RT that defines eligibility for the ARORP
- •Intact Prostate;
- •- Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection prior to the course of RT that defines eligibility for the ARORP
- •- Previous pelvic RT or surgery (eg abdomino-perineal resection) prior to the course of RT that defines eligibility for the ARORP
- •- Hip prosthesis prior to the course of RT that defines eligibility for the ARORP
- •- Inflammatory bowel disease prior to the course of RT that defines eligibility for the ARORP
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