Assesment of New Radiation Oncology Technologies and Treatments

Not Applicable

Completed

• Conditions: Anal Cancer; Nasopharyngeal Cancer; Cancer - Other cancer types; Cancer - Bowel - Anal; Intermediate Risk Prostate Cancer; Cancer - Prostate; Prostate Cancer (Post Prostatectomy)

• Registration Number: ACTRN12612000168853
• Lead Sponsor: Trans Tasman Radiation Oncology Group Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the dosimetry of treatment plans prepared using the new technologies against those prepared using the conventional standard approaches as a surrogate for effectiveness and safety[Prospective participants: Plans produced before comencement of treatment<br>Retrospective participants and datasets: Plans produced before comencement of treatment (reproduced after registration for the purpose of the study).<br>All radiotherapy plans are due for submission by mid February 2012.];Obtain data on the impact of disease and treatment on QoL[Propective participants: Baseline, during treatment (6 or 8 weeks) and post treatment (6weeks and/or 3 months) the exact timing depends on tumour type.<br>Retrospective participants: post treatment (more than or equal to 3 months post treatment)];Compare the resource usage associated with the planning and delivery of the new technologies compared to the conventional standard approaches[During data analysis]

Secondary Outcome Measures

Name	Time	Method
Synthesise the data obtained for objectives 1-3 together with information from previous studies and expert opinion into a decision analytic model to estimate the safety, clinical efficacy and cost-effectiveness of the new technologies compared to the conventional standards[During data analysis]