None listed
Conditions
Brief summary
The ANROTAT Radiation Oncology Register Pilot (ARORP) aims to assess the feasibility of using a practical system to collect accurate and complete treatment and outcome data for patients undergoing radiotherapy treatment for their cancer in the following indications: - Intermediate risk prostate cancer treated with IGRT or nonIGRT - Prostate Cancer Post Prostatectomy treated with IMRT or 3DCRT - Nasopharynx Cancer treated with IMRT or 3DCRT - Anal Cancer treated with IMRT or 3DCRT DESIGN There are two main design components to the ARORP: 1. An observational study in which data are entered into ARORP from a cohort of patients who received radiotherapy treatment for the indications described above 2. A crosssectional surveys of users of the ARORP at participating centres The opinions of ARORP users will be measured via an evaluation survey that asks for their rating (excellent, good, fair, or poor) of the system in terms of access, data entry, navigation, training, support, and overall ease of use. The proportion of users providing an overall rating of excellent or good will be calculated. Focus group discussions with ARORP users also will be performed at each centre to obtain qualitative feedback on the system (including such things as the burden on the staff collecting the data).
Interventions
The Department of Health and Ageing has asked the Trans Tasman Radiation Oncology Group (TROG) to develop and pilot a radiation oncology register as part of the ANROTAT (TRP 11.A) project (http://www.ANZCTR.org.au/ACTRN12612000168853.aspx).
The ARORP will include the development and testing of a set of data variables to capture demographics, diagnosis, staging, surgical treatments, quality of Life, follow-up and radiotherapy intervention related data. A cross sectional feedback survey of partic
The Department of Health and Ageing has asked the Trans Tasman Radiation Oncology Group (TROG) to develop and pilot a radiation oncology register as part of the ANROTAT (TRP 11.A) project (http://www.ANZCTR.org.au/ACTRN12612000168853.aspx). The ARORP will include the development and testing of a set of data variables to capture demographics, diagnosis, staging, surgical treatments, quality of Life, follow-up and radiotherapy intervention related data. A cross sectional feedback survey of participating centre staff authorised to enter data into the ARORP will be undertaken to assess the feasibility of the collection of the data items in routine practice as well as the web-based registration, the user manual and the register in general. Data will be collected in two groups of patients; 1. Prospective ANROTAT (TRP 11.A) study participants at or after the first follow-up visit 2. Patients who are attending for their annual follow-up appointment (including ANROTAT (TRP 11.A) retrospective patients and NON-ANROTAT patients). The data will be collected from the patients medical records, reports, RT plans and from QoL Questionniares. Patients are to be within 60months of completion of RT treament on registration, therefore the year range of the information collected will be from 2006-2012. The study population are patients who have undergone; - Image Guided Radiation Therapy (IGRT) or non-IGRT in patient with intermediate risk prostate cancer - Intensity Modulated Radiation Therapy (IMRT) or 3DCRT in patients with prostate cancer (post-proctectomy) - IMRT or 3DCRT in patients with nasophargeal cancer - IMRT or 3DRT in patients with anal cancer. This project will be open for registering patients from December 2011 to March 2012.
Sponsors
Trans Tasman Radiation Oncology Group
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed