Assessment of New Radiation Oncology Technologies and Treatments

NCT01379872 | Completed

• 1 other identifier: TRP.11A
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Prostate Cancer (Post Prostatectomy); Anal Cancer; Nasopharyngeal Cancer; Intermediate Risk Prostate Cancer

Keywords

Prostate; Head and Neck; Anal

Outcome Measures

Primary Outcomes (4)

• Comparison of dosimetry between treatment plans prepared using IMRT/IGRT vs 3DCRT/Non IGRT as a surrogate for effectiveness and safety.

  Measured By: 1. Tumour control estimated from surrogate physical dose endpoints with each of the new technologies as compared with standard therapy. 2. The likelihood of acute or long term damage to organ/tissue and resultant likelihood of impairment of function or QoL estimated from surrogate physical dose endpoints with each of the new technologies as compared with standard therapy.

  6 Months

• Obtain Data on the impact of disease and treatment on QoL

  Measured by 1. QALYs gained, and cost-per-QALY gained 2. The likely cost increases or savings resulting from differences in acute or long term toxicity.

  6 months

• Compare the resource usage associated with the planning and delivery of the new technologies compared to the conventional standard approaches

  1. The differences in time and resources required for preparation, planning, quality assurance (QA) checking and treatment for each of the new technologies as compared with standard therapy. 2. The likely cost increases or savings associated with differences in time and resources involved in the management of patients with each of the new technologies as compared with standard therapy.

  6 months

• Synthesise the data obtained for objectives 1-3 together with information from previous studies and expert opinion to estimate the safety, clinical efficacy and cost-effectiveness of new technologies compared to conventional standards

  1\. QALYs gained, and cost-per-QALY gained

  6 months

Study Arms (4)

Study Protocol A - IMRT Post Prostatectomy

* 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

Other: Non-Interventional Study

Study Protocol B - IMRT Anal Cancer

* Retrospective Patient Datasets * Prospective Participants (dosimetric evaluation and toxicity/QoL study)

Other: Non-Interventional Study

Study Protocol C - IMRT Nasopharynx

* Retrospective Patient Datasets * Prospective Participants (dosimetric evaluation and toxicity/QoL study) * Post-Treatment Prospective Participants (toxicity/QoL and cost study)

Other: Non-Interventional Study

Study Protocol D - IGRT Intact Prostate

Patients with prostate cancer \- A sample of 30 patients from at least 10 centres that are to be treated for intermediate risk prostate cancer will be enrolled. The sample will be selected to comprise at least 10 patients that will undergo non-IGRT, 10 that will undergo IGRT with fiducials and planar imaging, and 10 that will undergo IGRT with volumetric imaging.

Interventions

Non-Interventional Study OTHER

This is a non-interventional study

Study Protocol A - IMRT Post Prostatectomy; Study Protocol B - IMRT Anal Cancer; Study Protocol C - IMRT Nasopharynx

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study Protocol A - IMRT Post Prostatectomy: Patients with prostate cancer (post prostatectomy) Study Protocol B - IMRT Anal Cancer: Patients with anal cancer Study Protocol C - IMRT Nasopharynx: Patients with nasopharynx cancer Study Protocol D - IGRT Intact Prostate: Patients with prostate cancer

You may qualify if:

• 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
• years or older

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Trans Tasman Radiation Oncology Group: lead

Study Sites (15)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 1871, Australia

Location

Calvary Mater Newcastle

Newcastle, New South Wales, 2298, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Illawarra Cancer Care Centre

Wollongong, New South Wales, 2500, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Radiation Oncology Queensland - Toowoomba

Toowoomba, Queensland, Australia

Location

Adelaide Radiotherapy Centre

Adelaide, South Australia, Australia

Location

WP Holman Clinic - Royal Hobart

Hobart, Tasmania, 7000, Australia

Location

WP Holman Clinic - Launceston

Launceston, Tasmania, 7250, Australia

Location

Andrew Love Cancer Care Centre, Geelong Hospital

Geelong, Victoria, 3220, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 8006, Australia

Location

Alfred Hospital

Prahran, Victoria, 3181, Australia

Location

Related Links

• Click here for more information about this study on the TROG official website

MeSH Terms

Conditions

Prostatic Neoplasms; Anus Neoplasms; Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Bryan Burmeister

  Trans Tasman Radiation Oncology Group

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 23, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 13, 2013

Record last verified: 2011-06

Locations

AU (15)