A randomised trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer

A randomised study in rectal cancer comparing sphincter preservation following preoperative short-course radiotherapy with immediate surgery or following preoperative conventionally fractionated chemoradiation and delayed surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38817884

Enrollment

316

Registered

2008-01-30

Start date

1999-04-01

Completion date

Unknown

Last updated

2022-11-28

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

Conditions

Rectal cancer Cancer Rectal cancer

Interventions

Patients are randomised to receive either: 1. Preoperative 5 x 5 Gy irradiation with total mesorectal excision (TME) performed within 7 days, or 2. Chemoradiation (50.4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Clinical stage T3 or cT4 resectable primary tumour 2. No evidence of sphincter involvement on digital rectal examination 3. Lower tumour margin accessible to digital rectal examination 4. No distant metastases 5. Aged 75 years or less, either sex 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. T4 fixed tumour 2. Previous irradiation 3. Second primary tumour

Design outcomes

Primary

Measure	Time frame
Anterior resection rate.	—

Secondary

Measure	Time frame
1. Long-term overall survival 2. Disease-free survival 3. Local control 4. Quality of life 5. Anorectal function 6. Distal bowel intramural spread 7. Local control in relation to distal bowel margin	—

Countries

Poland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026