Clinical trial · Observational
Assessment of New Radiation Oncology Technologies and Treatments
The Assessment of New Radiation Oncology Technologies and Treatments (ANROTAT) TROG Research Project TRP11.A
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Trans Tasman Radiation Oncology Group (TROG) has been commissioned by the Department of Health and Ageing to undertake a project to assess new Radiation Oncology Technology and Treatments. This project is being undertaken in response to a recognised need for the Medicare Benefits Schedule to support appropriate new radiation oncology technologies and treatments as they become available, to ensure optimal patient care. The first phase of the project required TROG to develop a Generic Research Framework (the Framework) capable of collecting and generating information to substantiate the safety, clinical efficacy and cost effectiveness of new technologies and treatments. The second (and current) phase of the project requires that the Framework be piloted to assess the safety, clinical efficacy and cost effectiveness of Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT) in four tumour site specific regions: A. Post Prostatectomy(IMRT) B. Anal Cancer (IMRT) C. Nasopharynx (IMRT) D. Intermediate Risk Prostate Cancer (IGRT) The aims of the site specific components of the ANROTAT protocol are as follows: Protocol A. Develop an approach for applying the Framework to evaluate the safety, clinical efficacy and cost-effectiveness of IMRT compared to 3DCRT in patients with prostate cancer (PP). Protocol B. Develop an approach for applying the Framework to evaluate the safety, clinical efficacy and cost-effectiveness of IMRT compared to 3DCRT in AC. Protocol C. Develop an approach for applying the Framework to evaluate the safety, clinical efficacy and cost-effectiveness of IMRT compared to 3DCRT in NPC. Protocol D. Develop an approach for applying the Framework to evaluate the safety, clinical efficacy and cost-effectiveness of IGRT compared to non-IGRT in patients with intermediate risk prostate cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Intermediate Risk Prostate Cancer | — | UNRESOLVED | — |
| Nasopharyngeal Cancer | Malignant Nasopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer (Post Prostatectomy) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Study Protocol A - IMRT Post Prostatectomy
- description
- * Prospective TROG 08.03 (RAVES) Participants * Prospective Participants (NOT participating in TROG 08.03 (RAVES)) * Retrospective TROG 08.03 (RAVES) Participants * Participating in dosimetric evaluation and toxicity/QoL study * Participating in dosimetric evaluation only
- interventionNames
- Other: Non-Interventional Study
- label
- Study Protocol B - IMRT Anal Cancer
- description
- * Retrospective Patient Datasets * Prospective Participants (dosimetric evaluation and toxicity/QoL study)
- interventionNames
- Other: Non-Interventional Study
- label
- Study Protocol C - IMRT Nasopharynx
- description
- * Retrospective Patient Datasets * Prospective Participants (dosimetric evaluation and toxicity/QoL study) * Post-Treatment Prospective Participants (toxicity/QoL and cost study)
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Study Protocol A: IMRT versus 3DCRT in Post-Prostatectomy Inclusion Criteria All of the following must apply: * Patient has provided written informed consent * 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 ≤ 1.0 ng/ml following RP * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 * Sufficient knowledge of English and adequate cognitive function to be able to complete the QoL and other questionnaires * 18 years or older Exclusion Criteria None of the following must apply: * 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 \>1.0 ng/ml * Co-morbidities that would interfere with the completion of treatment * Concurrent cytotoxic medication * Hip prosthesis Study Protocol B: IMRT versus 3DCRT in Anal Cancer Inclusion Criteria All of the following must apply: * Informed consent for prospective patients (QoL component) * 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 * 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. Exclusion Criteria None of the following must apply: * 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 Study Protocol C: IMRT versus 3DCRT in Nasopharynx Inclusion Criteria All of the following must apply: * Informed consent for prospective patients (QoL component) * Age \>18 years * 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 * 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). * Disease must be considered potentially curable by chemoradiation * Patients must be medically fit for cisplatin chemotherapy according to local practice (adequate renal, cardiac function, no significant neurological co-morbidities) * Performance status ECOG 0, 1 or 2. Exclusion Criteria * Previous head and neck RT or major surgery * Prior chemotherapy \< 6 months from study entry Study Protocol C: IGRT versus non-IGRT in Intact Prostate Inclusion Criteria * Patient has provided written informed consent * 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 \< 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 ≤ 6, PSA 10.1-20.0 ng/ml; T2b-c, Gleason ≤6, PSA ≤ 20.0 ng/ml; T1-2, Gleason 7, PSA ≤ 20.0 ng/ ml) Exclusion Criteria * 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 * Previous or current use of AD
References
Publications (0)
Data not yet available