Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

The ANROTAT study is divided into four tumour site specific studies. A decision analytic model will be constructed for each disease area/technology to estimate the safety, clinical efficacy and cost effectiveness of the new technology compared to conventional standard treatment approach. This will incorporate information from previous studies and data from a series of component studies including a dosimetric evaluation, a QoL evaluation, and an evaluation of the cost of treatment planning and delivery. The development and refinement of these models is an integral component of the planned research program. The overall protocol details the data collection activities that have been identified as feasible and useful for informing the development of a series of decision analytic models to evaluate IMRT and IGRT for the four specified cancers.

These activities involve the collection of dosimetry data, quality of life (QoL) and toxicity data, and health care resource usage data in a series of component studies. These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of the decision analytic models.

Data will be collected from at least 10 treatment centres for each of the site specific studies. Data will be transcribed onto CRFs from source data forms. The CRFs will be sent to TROG Cancer Research on a secure fax line.

Participant's treatment plans will be securely uploaded to the TROG Central Quality Management System (CQMS) for plan review.

The data to be collected, number of participants and tasks for participants is outlined below for each of the site specific studies. WBRC has been invited to participate in Studies A and B only, however, ethics approval is sought for the entire ANROTAT protocol so our centre has approval and the option to participate in all components of ANROTAT where required.

Study Protocol A IMRT versus 3DCRT in Post Prostatectomy:

The post prostatectomy study methodology applies the ANROTAT framework and includes a series of component studies including a dosimetric evaluation, a QoL/toxicity evaluation, and an evaluation of the cost of treatment planning and delivery. This involves the collection of data from approximately 30 patients. Data collection includes eligibility, adverse events/toxicity, QoL, patient costs, and dosimetry parameters (contouring, planning, quality assurance, treatment data). These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of a decision analytic model.

Centres will be asked to provide two retrospective and one prospective patient but this will have to be varied according to the availability of retrospective patients at each participating centre. Each centre will be provided with details of case selection.

Data collected directly from patients will include QoL and toxicity data as well as costs incurred by the patient as a result of their treatment.

Study Protocol B IMRT versus 3DCRT in Anal Cancer:

The anal canal study methodology applies the ANROTAT framework and includes a series of component studies including a dosimetric evaluation, a QoL/toxicity evaluation, and healthcare resource usage. This involves the collection of data from 30 patients. Data collection includes eligibility, adverse events/toxicity, QoL, patient costs, and dosimetry parameters (contouring, planning, quality assurance, treatment data). These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of a decision analytic model.

Participating centres will be asked to provide data on the contouring and planning of a CT data set that will be sent to each of the participating centres. Following this, each participating centre will plan 3 retrospective patient cases each. In addition to this, data will be collected from 10 prospective anal cancer patients who will be asked to complete QoL and patient cost questionnaires.

Study Protocol C IMRT versus 3DCRT in NPC:

The nasopharynx study methodology applies the ANROTAT framework and includes a series of component studies including a dosimetric evaluation, a QoL/toxicity evaluation, and healthcare resource usage. This involves the collection of data from 30 patients for the dosimetry component and 150 patients for the QoL component.

Data collection includes eligibility, adverse events/toxicity, QoL, patient costs, and dosimetry parameters (contouring, planning, quality assurance, treatment data). These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of a decision analytic model.

Participating centres will be asked to provide data on the contouring of a CT data set that will be sent to each of the participating centres. Following this, the dosimetry component will require centres to recruit as many prospective patients as possible to collect the above mentioned data. Due to the short time frame, if 30 prospective patients cannot be recruited in the time frame, this will be supplemented with retrospective cases. In addition to this, data will be collected from 150 nasopharynx patients who will be asked to complete QoL and patient cost questionnaires.

Study Protocol D IGRT versus non IGRT in Intermediate Risk Prostate Cancer:

The IGRT study methodology applies the ANROTAT framework and includes a series of component studies including a dosimetric evaluation, a QoL/toxicity evaluation, and healthcare resource usage. This involves the collection of data from 30 prospective patients.

Data collection includes eligibility, adverse events/toxicity, QoL, patient costs, and dosimetry parameters. These data will be used in conjunction with evidence from the existing literature and expert opinion to inform the construction of a decision analytic model.

Data collected directly from patients will include QoL and toxicity data as well as costs incurred by the patient as a result of their treatment. ;


Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT01379872
Study type Observational
Source Trans-Tasman Radiation Oncology Group (TROG)
Contact
Status Completed
Phase N/A
Start date June 2011
Completion date June 2012

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05060471 - PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced SCCA Patients Phase 2
Active, not recruiting NCT02135419 - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions Phase 3
Completed NCT05518201 - Evaluate the Safety and Immunogenicity of a 9-valent HPV Vaccine in Chinese Healthy Male Aged 9-45 Year-old Phase 1
Withdrawn NCT02857608 - A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus Phase 2
Active, not recruiting NCT02546973 - Quality of Life in Patients With Anal Cancer
Terminated NCT00903396 - Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer Phase 2
Terminated NCT00896467 - Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy N/A
Completed NCT00550589 - Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus Phase 2
Completed NCT00324415 - Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer Phase 2
Terminated NCT00568425 - QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT
Terminated NCT00267787 - Molecular Genetic and Pathological Studies of Anal Tumors
Completed NCT00066430 - Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Phase 1
Completed NCT04083053 - High-Resolution Anoscopy Perceived Discomfort Study N/A
Completed NCT03506529 - Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT
Recruiting NCT05835947 - Anal Cancer Risk In Women
Not yet recruiting NCT03947775 - HPV-SAVE_Merck_Sub-Study for Preventing Recurrence of HSIL Phase 2
Recruiting NCT04857528 - Detecting HPV DNA in Anal and Cervical Cancers
Recruiting NCT04907643 - Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes N/A
Recruiting NCT04708470 - A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers Phase 1/Phase 2
Active, not recruiting NCT01937780 - Anal Cancer Radiotherapy Study