Preoperative short-term radiotherapy for primary resectable rectal cancer: Accelerated once daily (5x5Gy) versus accelerated hyperfractionated twice daily (12x2,5Gy b.i.d.) (ONCE-TWICE trial) A phase II single-blinded multi-institutional randomised study

Phase 2

• Conditions: bowel cancer; rectal cancer; 10017991

• Registration Number: NL-OMON29980
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 210

Inclusion Criteria

- Primary resectable rectal cancer. All patients with primary resectable rectal cancer are eligible for the study, regardless whether a low anterior resection with primary anastomosis or an abdominoperineal resection is planned.
- Histologically proven adenocarcinoma
- No distant metastases
- No prior radiotherapy to the pelvis or abdomen
- Age >18 years
- WHO performance score 0-2
- Patients at reproductive age must agree to practice an effective contraceptive method
- Written informed consent

Exclusion Criteria

- Non-resectable rectal cancer (or resectability uncertain)
- Histology other than adenocarcinoma
- Distant metastases
- Pregnancy or lactation
- Psychological, familial, sociological or geographical reasons hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>CTCAE v3.0 - anal incontinence Grade 2 or higher at one year post treatment (or<br /><br>at 18 months in case of late closure of a stoma).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> All at one year post treatment (or at 18 months in case of late closure of a<br /><br>stoma) and also three and five years post treatment:<br /><br>1. MSKCC Bowel Function Instrument<br /><br>2. Local control<br /><br>3. Disease free survival<br /><br>4. Overall survival<br /><br>5. Quality of life (assessed by the EORTC QLQ-C30)</p><br>