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TROG 08.03 (RAVES)

Overview

Title: Radiotherapy - Adjuvant Versus Early Salvage. A Phase III Multi-centre Randomised Trial Comparing Adjuvant Radiotherapy (RT) With Early Salvage RT in Patients With Positive Margins or Extraprostatic Disease Following Radical Prostatectomy.

Primary sponsor: Trans Tasman Radiation Oncology Group (TROG)
Collaborating groups: Urological Society of Australia & New Zealand (USANZ); Australian & New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP); Psycho-Oncology Co-operative Research Group (PoCoG)

Final Accrual: 333

Expected closed to follow-up date: December 2021

Trial chair/s:
Dr Maria Pearse, Auckland Hospital, NZ
Email: MariaP@adhb.govt.nz

Trial contact:
Ms Carol Fraser-Browne
Auckland Regional Cancer and Blood Service, Private Bag 92024, Auckland, New Zealand 1142
Phone: +64 9 307 4949 ext 25197
Email: CarolFB@adhb.govt.nz

Clinical trial registration:
ANZCTR: NCT00860652
www.clinicaltrials.gov: NCT00860652


Trial documentation

Protocol
Case Reports Forms
Certificate of Currency
SAE Form


Quality Assurance

In the RAVES trial, the quality assurance programme will allow us to confirm that participants have understood the technical guidelines within the protocol and implemented them correctly and that the dose prescription is delivered with appropriate documentation.

The programme consists of two parts:

  1. Each clinician that will be entering patients into the trial will be required to participate in a dry run contouring exercise before recruiting the first patient (credentialing).

  2. For all registered patients, treatment planning data will be submitted in electronic format.

The following documents can be used to assist in completing both parts of the Quality Assurance Programme

Summary for Radiation Therapists
Section 8 of the RAVES Protocol
Guidelines for Contouring
IMRT Credentialing Requirements
 

The data from the quality assurance programme will be analysed separately from the main trial. You will be notified of any major discrepancies

Credentialing

Facility Questionnaire
Benchmarking Instructions
Benchmarking CT Data Set - Patient A
Benchmarking Data Submission Form

Patient Case Review

QA Checklist - Eligibility
QA Checklist - RT Planning
QA Checklist - RT Treatment


Interim results

Please refer to the TROG Publications page 

Publications:
Sundaresan P, Turner S, Kneebone A, Pearse M, Butow P. Evaluating the utility of a patient decision aid for potential participants of a prostate cancer trial (RAVES-TROG 08.03). Radiother Oncol. 2011; 101 (3): 521-524.

Pearse M, Fraser-Browne CL, Davis ID, Duchesne GM, Fisher R, Frydenberg M, Haworth A, Jose C, Joseph DJ, Lim T, Matthews J, Millar J, Sidhom M, Spry N, Tang C, Turner S, Williams SG, Wiltshire K, Woo HH, Kneebone A. A Phase III trial to investigate the timing of radiotherapy for prostate cancer with high-risk features: background and rationale of the RAVES trial (Radiotherapy – Adjuvant Versus Early Salvage).  British Journal of Urology International.  2014; 113 (S2): 7-12.

Sundaresan P, Turner S, Kneebone A, Pearse M, Fraser-Browne C, Woo HH.  Do screening trial recruitment logs accurately reflect the eligibility criteria of a given clinical trial? Early Lessons from the 08.03 RAVES Trial. Clinical Oncology.  2014; 26(6): 348-352.

Presentations:

  • Sproston C, Willis D, Thompson A, Kneebone A, Pearse M, Wiltshire K, Haworth A. Rants on RAVES (Radiotherapy Adjuvant Versus Early Salvage): The challenge to meet dose constraints. J Medical Imaging and Radiation Oncology Vol 53, Supplement 1, Oral abstracts O22 – Scientific Paper/oral. RANZCR/AIR/FRO/ACPSEM Combined Scientific Meeting, October 2009.
  • Haworth A, Wiltshire KL, Kneebone A, Sproston C, Willis AD, Thompson A, Sidhom M, Tang C, Williams S and Pearse M. Importance of bench marking exercises in new trial protocols – the TROG 08.03 experience. European Society for Therapeutic Radiology and Oncology (ESTRO) Annual Scientific meeting. Barcelona September 2010.
  • Woo H. TROG 08.03: RAVES (Radiotherapy Adjuvant Versus Early Salvage). 12th Australasian Prostate Cancer Conference, Melbourne August 2011.
  • Pearse M, Kneebone A, Duchesne G, Fisher R, Fraser-Browne C, Frydenberg M, Haworth A, Jose C, Joseph J, Lim T, Matthews J, Millar J, Sidhom M, Spry N, Tang C, Turner S, Williams S, Wiltshire K, Woo H, Davis I. What is optimal timing of post prostatectomy radiotherapy? Is adjuvant radiotherapy equivalent to early salvage radiotherapy? The "RAVES" phase III randomized clinical trial. J Clin Oncol. 2012; 30 (15 suppl): TPS4690.

Substudies

RAVES DA (TROG 0803 substudy)

Our values are collaboration, quality and care.


Latest News

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