Assessment of New Radiation Oncology Technologies and Treatments (ANROTAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT01379872
First received: June 8, 2011
Last updated: February 12, 2013
Last verified: June 2011
  Purpose

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.


Condition Intervention
Prostate Cancer (Post Prostatectomy)
Anal Cancer
Nasopharyngeal Cancer
Intermediate Risk Prostate Cancer
Other: Non-Interventional Study

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: The Assessment of New Radiation Oncology Technologies and Treatments (ANROTAT) TROG Research Project TRP11.A

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • Comparison of dosimetry between treatment plans prepared using IMRT/IGRT vs 3DCRT/Non IGRT as a surrogate for effectiveness and safety. [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

    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.

  • Obtain Data on the impact of disease and treatment on QoL [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.

  • Compare the resource usage associated with the planning and delivery of the new technologies compared to the conventional standard approaches [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    1. QALYs gained, and cost-per-QALY gained


Enrollment: 138
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
This is a non-interventional study
Study Protocol B - IMRT Anal Cancer
  • Retrospective Patient Datasets
  • Prospective Participants (dosimetric evaluation and toxicity/QoL study)
Other: Non-Interventional Study
This is a 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
This is a 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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01379872

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Illawarra Cancer Care Centre
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Radiation Oncology Queensland - Toowoomba
Toowoomba, Queensland, Australia
Australia, South Australia
Adelaide Radiotherapy Centre
Adelaide, South Australia, Australia
Australia, Tasmania
WP Holman Clinic - Royal Hobart
Hobart, Tasmania, Australia, 7000
WP Holman Clinic - Launceston
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, Australia, 3220
Austin Health
Heidelberg, Victoria, Australia, 3084
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 8006
Alfred Hospital
Prahran, Victoria, Australia, 3181
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Investigators
Study Chair: Bryan Burmeister Trans-Tasman Radiation Oncology Group (TROG)
  More Information

Additional Information:
No publications provided

Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT01379872     History of Changes
Other Study ID Numbers: TRP.11A
Study First Received: June 8, 2011
Last Updated: February 12, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Prostate
Head and Neck
Anal

Additional relevant MeSH terms:
Anus Neoplasms
Prostatic Neoplasms
Nasopharyngeal Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 01, 2014