A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer

A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer

The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.

Primary Outcome measures are 3-year locoregional control, progression-free and overall survival rates.

Secondary outcome measures are toxicities scores up to 3 months after surgery (acute) and greater than 3 months after surgery (late). Data collected at 3-6 month intervals for 30 months

Inclusion Criteria:

• locally advanced or recurrent rectal cancer
• suitable for radical surgery but at high risk of positive resection margins,
• no evidence of metastasis,
• age greater than 18 years,
• histologically confirmed adenocarcinoma,
• ECOG performance status <2.
• Informed consent

Exclusion Criteria:

• unresectable pelvic disease
• distant metastasis
• significant co-morbidities