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

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 - ONCE-TWICE trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29980

Enrollment

210

Registered

2006-09-12

Start date

2006-08-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bowel cancer rectal cancer

Interventions

Arm A: 5 x 5 Gy preoperative pelvic radiotherapy (standard) Arm B: 12 x 2,5 Gy preoperative pelvic radiotherapy (experimental arm) Comment: On the basis of the most accepted radiobiological modelling

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
CTCAE v3.0 - anal incontinence Grade 2 or higher at one year post treatment (or at 18 months in case of late closure of a stoma).	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)