Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer: CHHIP

 

Randomised Phase III multi-centre study supported by CTAAC, with quality assurance from the Department of Health and NCRN.

 

 

Objectives of the Study:

  1. To test the hypothesis that hypofractionated radiotherapy schedules for localised prostate cancer will improve the therapeutic ratio by either:

- Improving tumour control, or

- Reducing normal tissue side effects.

  1. To limit acute and late gastro-intestinal and urological toxicity.
  2. To evaluate different PSA related endpoints for local failure and distant metastases.
  3. To extend the database of patients treated to escalated doses with dose volume histograms (DVHs) of normal tissues at risk and to relate these to common toxicity endpoints.
  4. To develop a model to estimate normal tissue complication probability (NTCPs) of rectum and bladder for hypofractionated as well as conventional dose escalated radiotherapy schedules.

 

 

Forward or inverse 3D planning will be undertaken using standard beam arrangements to achieve the required dose distributions in a single treatment 'phase'.

 

 

 

 

 

      CHHIP Trial Randomisation arms

 

 

 

Participating Centres  (Phase II)

 

 

 

CHHIP QA Requirements

 

The diagram below summarises the QA steps for the CHHIP trial.

 

 

Details of the QA exercises are provided in the following document :

Overview of CHHIP Phase III QA requirements and are summarised below.

Questionnaires

 

Outlining exercise

To be performed using an interactive tool developed by the Institute for Cancer Research once software development has been completed.

 

Planning Exercise

Two CHHIP cases (one low risk, one moderate risk) must be planned and returned electronically to the QA Centre for analysis.

Instructions for planning exercise

Instructions for completing CHHIP physics plan assessment form

CHHIP physics plan assessment form (PDF)

CHHIP physics plan assessment form (Excel)

 

Process document

A process document template has been created.

 

Case reviews

The case reviews will include a review of the structure outlines and an assessment of the plan. The first 2 patients will be reviewed, and if these are both in the same risk group then the next patient from the other risk group will be reviewed in addition.

Case review instructions

Clinical data for case reviews

 

Site visits

An audit visit will be performed within 6 months of the first patient starting treatment at a centre and will include point dose measurements and field fluence verification using film.

CHHIP audit visit instructions

CHHIP audit visit measurement form

 

 

Contact details for QA Centre

 

Olivia Naismith (CHHIP QA Physicist)

Department of Physics

Royal Marsden NHS Foundation Trust,

Fulham Road,

London  SW3 6JJ

 

Clinical Outlining for CHHIP

 

For Phase III of the trial the urethral bulb will be outlined and dose-volume information provided for each patient on the CHHIP Physics plan assessment form. This follows evidence from the RT01 trial on dose-volume effects on the bulb:

SA Mangar et al. Evaluating the relationship between erectile dysfunction and dose received by the penile bulb: Using data from a randomised controlled trial of conformal radiotherapy in prostate cancer (MRC RT01, ISRCTN47772397). Rad Oncol, 80(3), 2006, pp 355-362.

 

Some examples of how to outline the urethral bulb are provided here:

Example 1

Example 2

Example 3

Example 4

 

 

The purpose of the case reviews and the outlining instructions in the CHHIP Trial Protocol is to ensure consistency in clinical outlines between all centres participating in the trial. Some common issues arising in the outlining for CHHIP are illustrated in the following slides:

Outlining issues from CHHIP case reviews