A randomised trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer
| ISRCTN | ISRCTN38817884 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38817884 |
| Secondary identifying numbers | 4 P05C 03917 |
- Submission date
- 14/01/2008
- Registration date
- 30/01/2008
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Krzysztof Bujko
Scientific
Scientific
Department of Radiotherapy
Maria Sklodowska-Curie Memorial Cancer Centre
Roentgena 5
Warsaw
02-781
Poland
| Phone | +48 (0)22 643 92 87 |
|---|---|
| bujko@coi.waw.pl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | 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 |
| Study objectives | Tumour shrinkage after conventional chemoradiation and delayed surgery increases anterior resection rate as compared to preoperative short-course radiotherapy with immediate surgery. |
| Ethics approval(s) | Ethics approval received from the Regional Ethics Committee at the Maria Sklodowska-Curie Memorial Cancer Centre in Warsaw (Poland) on the 18th January 1999 (ref: 3/99). All other centres have received full ethics approval before the first participant was recruited in that centre. |
| Health condition(s) or problem(s) studied | Rectal cancer |
| Intervention | 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 Gy) followed by TME 4 - 6 weeks later Living patients were followed up for a median of 48 months, range 31 - 69 months. |
| Intervention type | Other |
| Primary outcome measure | Anterior resection rate. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/1999 |
| Completion date | 28/02/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 316 |
| Total final enrolment | 316 |
| Key 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 |
| Key exclusion criteria | 1. T4 fixed tumour 2. Previous irradiation 3. Second primary tumour |
| Date of first enrolment | 01/04/1999 |
| Date of final enrolment | 28/02/2002 |
Locations
Countries of recruitment
- Poland
Study participating centre
Department of Radiotherapy
Warsaw
02-781
Poland
02-781
Poland
Sponsor information
Polish State Committee for Scientific Research (Poland)
Government
Government
Wspolna 1/3
Warsaw
02-529
Poland
| Phone | +48 (0)22 529 26 23 |
|---|---|
| sekretariat.bg@nauka.gov.pl | |
| Website | http://kbn.icm.edu.pl |
"ROR" |
https://ror.org/05pwfyy15 |
Funders
Funder type
Government
Polish State Committee for Scientific Research (Poland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/07/2004 | Yes | No | ||
| Other publications | 01/07/2005 | Yes | No | ||
| Other publications | 01/09/2005 | Yes | No | ||
| Other publications | 01/05/2006 | Yes | No | ||
| Other publications | 01/10/2006 | Yes | No | ||
| Other publications | 01/02/2007 | Yes | No | ||
| Other publications | 01/09/2007 | Yes | No |
Editorial Notes
14/11/2022: Total final enrolment added.
