ACTRN12612000168853已完成未知
The assessment of New Radiation Oncology Technologies and treatments (ANROTAT) in Post Prostatectomy, Anal Cancal, Nasopharynx and Intact Prostate (TRP11.A)
Trans Tasman Radiation Oncology Group Ltd0 个研究点目标入组 120 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
- 120
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
- •All protocols:
- •- Patient has provided written informed consent
- •- Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires
- •Protocol A (Post Prostatectomy):
- •- Prior Radical Prostatectomy 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
- •- ECOG performance status 0 – 1
- •- Patients participating in the Toxicity and QoL evaluation QoL data must be scheduled to undergo RT or must have completed RT within the previous 12 months
- •Protocol B (Anal Canal):
- •- Histological confirmation of squamous cell carcinoma or basaloid carcinoma within the past 6 weeks
- •- T2-4N0, TanyN2 (ipsilateral groin nodes) and TanyN3 (bilateral groin nodes)
- •- Intention to elective irradiate all pelvic nodal groups up to L5-S1 interspace (including mesorectal, presacral, internal iliac, external iliac, ischiorectal fossa, obturator and inguinal groups)
- •- Planned for radical chemoradiation
- •Protocol C (Nasopharynx):
- •- Histologically confirmed carcinoma of the nasopharynx, types WHO1-111, Stage I-IVB within the past 6 weeks
- •- Adequate staging of local disease and exclusion of distant metastatic disease within the past 6 weeks.
- •- Disease must be considered potentially curable by chemoradiation
- •- Patients must be medically fit for cisplatin chemotherapy according to local practice
- •- Performance status ECOG 0, 1 or 2.
- •- Patients participating in the cross sectional study of QoL must have completed radiation therapy treatment within 18-30 months prior to the date of informed consent (or 60 months in selected sites)
- •Protocol D (Intact Prostate):
- •- Histological diagnosis of carcinoma of the prostate less than or equal to 6 months of entry 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)
排除标准
- •Protocol A (Post Prostatectomy):
- •- Previous pelvic RT or surgery ie previous rectal or bladder resection
- •- Concurrent or previous 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
- •- Evidence of nodal or distant metastases
- •- Clinical or imaging evidence of local recurrence
- •- Planned adjuvant RT to cover pelvic lymph nodes
- •- PSA greater than 1.0 ng/ml
- •- Co-morbidities that would interfere with the completion of treatment
- •- Concurrent cytotoxic medication
- •- Hip prosthesis
- •Protocol B (Anal Canal):
- •- Evidence of metastatic disease
- •- Prior pelvic RT/ surgery (e.g. vaginal hysterectomy)
- •- Presence of hip prosthesis
- •- Acquired immunodeficiency syndrome (AIDS). HIV patients without AIDS eligible.
- •- Previous pelvic cancers
- •Protocol C (Nasopharynx):
- •- Previous head and neck RT or major surgery
- •- Prior chemotherapy less than or equal to 6 months from study entry
- •Protocol D (Intact Prostate):
- •- Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection.
- •- Previous pelvic RT or surgery (eg abdomino-perineal resection)
- •- Hip prosthesis
- •- Inflammatory bowel disease
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