Introducing the Intergroup 0116 protocol of adjuvant chemo-radiotherapy in gastric cancer into clinical practice

The results of techniques from a well-conducted clinical trial are often difficult to reproduce when implemented in community oncology practice. The U.S. Intergroup 0116 protocol of adjuvant chemo-radiotherapy in gastric cancer presented in mid-2000 produced a survival advantage over surgery alone. The current study aims to determine the adherence with protocol design and delivery of radiation therapy (radiotherapy) in the initial 20 patients managed with the Intergroup 0116 protocol at The National University Hospital, Singapore.

A formal quality assurance audit was performed on clinical features, radiotherapy treatment charts and simulation films of the first 20 patients treated with the Intergroup 0116 protocol from July 2000 to September 2001. Specific details were audited for their consistency with described protocol in domains of eligibility criteria, radiotherapy prescription, target volume coverage and adherence to dose-limiting normal tissue tolerances. Compliance and toxicity with the protocol was assessed by audit of delivered radiotherapy dose, treatment interruptions, inpatient admissions and weight loss during radiotherapy.

The 20 audited patients were appropriately selected on the basis of eligibility criteria of Intergroup 0116 protocol. There was only one minor variation of radiotherapy target volume coverage resulting from marginal coverage of the porta hepatis region. Adherence to the protocol was satisfactory, with 19 patients completing the radiotherapy protocol as planned and only one major variation in treatment delivery resulting from gastrointestinal toxicity. One major and one minor variation in normal tissue-dose constraints occurred on the heart and spinal cord, respectively. Compliance with treatment delivery was good, with only one patient failing to complete the prescribed radiotherapy dose owing to toxicity, although seven patients required treatment interruption.

This audit showed good compliance with radiotherapy design and delivery. A formal medical quality assurance audit may provide a useful tool to assess complex new protocols introduced into routine departmental practice.