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

Peter MacCallum Cancer Centre, Australia

Status and phase: Completed; Phase 2

Conditions: Malignant Rectal Neoplasm; Recurrent Tumor

Treatments: Radiation: intraoperative radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01493206

PMCC04/16

Details and patient eligibility

About

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

Full description

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

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

intraoperative radiotherapy

Experimental group

Treatment:

Radiation: intraoperative radiotherapy