Quality assurance of the 22961 EORTC trial. A phase III study of the optimal combination of hormonal adjuvant treatment by LHRH analogue and radiation therapy for the management of locally advanced prostate cancer: the dummy run.

What Was Tested

This phase 3 clinical trial looks at Gonadotropin-Releasing Hormone.

The EORTC trial 22961, opened in 1997, was designed to investigate the optimal combination of hormonal adjuvant treatment by LHRH analogue and radiation therapy for the management of locally advanced prostate cancer.

A dummy run was established to assess centre compliance to the radiotherapy protocol.

Who Took Part

The age groups tagged for this paper are older adults, men only.

Medical and anatomical data obtained from 37 CT slices (5mm thickness) of an eligible patient were sent to 19 participating centres, which were asked to complete a questionnaire according to their practice and plan a theoretical radiotherapy treatment.

Centres which usually irradiate with small pelvic fields (N0 patients), were allowed to include the prostate, seminal vesicles and internal iliac lymph nodes plus a safety margin of 2 cm.

How the Study Was Run

For the Planning Target Volume 2 (PTV2), a safety margin of 1.5 to 2 cm should be around the prostate and seminal vesicles.

Checks included patient positioning, treatment simulation, target volume definition, treatment set-up and clinical controls during treatment.

What Was Measured

Topics PubMed links to this paper include Adenocarcinoma, Chemotherapy, Adjuvant, Combined Modality Therapy, Gonadotropin-Releasing Hormone, Prostatic Neoplasms, Quality Assurance, Health Care and Radiotherapy.

What This Means in Plain Language

This is a phase 3 clinical trial of Gonadotropin-Releasing Hormone.

The abstract goes on to report its results in about 10 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2004 (Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology), a journal based in Ireland.

More context: all human trials.