Condition category
Cancer
Date applied
14/01/2008
Date assigned
30/01/2008
Last edited
30/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Krzysztof Bujko

ORCID ID

Contact details

Department of Radiotherapy
Maria Sklodowska-Curie Memorial Cancer Centre
Roentgena 5
Warsaw
02-781
Poland
+48 (0)22 643 92 87
bujko@coi.waw.pl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4 P05C 03917

Study information

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

Acronym

Study hypothesis

Tumour shrinkage after conventional chemoradiation and delayed surgery increases anterior resection rate as compared to preoperative short-course radiotherapy with immediate surgery.

Ethics approval

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/1999

Overall trial end date

28/02/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

316

Participant exclusion criteria

1. T4 fixed tumour
2. Previous irradiation
3. Second primary tumour

Recruitment start date

01/04/1999

Recruitment end date

28/02/2002

Locations

Countries of recruitment

Poland

Trial participating centre

Department of Radiotherapy
Warsaw
02-781
Poland

Sponsor information

Organisation

Polish State Committee for Scientific Research (Poland)

Sponsor details

Wspolna 1/3
Warsaw
02-529
Poland
+48 (0)22 529 26 23
sekretariat.bg@nauka.gov.pl

Sponsor type

Government

Website

http://kbn.icm.edu.pl

Funders

Funder type

Government

Funder name

Polish State Committee for Scientific Research (Poland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/15236870
2. http://www.ncbi.nlm.nih.gov/pubmed/15932569
3. http://www.ncbi.nlm.nih.gov/pubmed/16273666
4. http://www.ncbi.nlm.nih.gov/pubmed/16530338
5. http://www.ncbi.nlm.nih.gov/pubmed/16983741
6. http://www.ncbi.nlm.nih.gov/pubmed/17118570
7. http://www.ncbi.nlm.nih.gov/pubmed/17692977

Publication citations

  1. Bujko K, Nowacki MP, Nasierowska-Guttmejer A, Michalski W, Bebenek M, Pudełko M, Kryj M, Oledzki J, Szmeja J, Słuszniak J, Serkies K, Kładny J, Pamucka M, Kukołowicz P, Sphincter preservation following preoperative radiotherapy for rectal cancer: report of a randomised trial comparing short-term radiotherapy vs. conventionally fractionated radiochemotherapy., Radiother Oncol, 2004, 72, 1, 15-24, doi: 10.1016/j.radonc.2003.12.006.

  2. Bujko K, Nowacki MP, Kepka L, Oledzki J, Bebenek M, Kryj M, , Postoperative complications in patients irradiated pre-operatively for rectal cancer: report of a randomised trial comparing short-term radiotherapy vs chemoradiation., Colorectal Dis, 2005, 7, 4, 410-416, doi: 10.1111/j.1463-1318.2005.00796.x.

  3. Bujko K, Nowacki MP, Nasierowska-Guttmejer A, Kepka L, Winkler-Spytkowska B, Suwiński R, Oledzki J, Stryczyńska G, Wieczorek A, Serkies K, Rogowska D, Tokar P, , Prediction of mesorectal nodal metastases after chemoradiation for rectal cancer: results of a randomised trial: implication for subsequent local excision., Radiother Oncol, 2005, 76, 3, 234-240.

  4. Chmielik E, Bujko K, Nasierowska-Guttmejer A, Nowacki MP, Kepka L, Sopylo R, Wojnar A, Majewski P, Sygut J, Karmolinski A, Huzarski T, Wandzel P, Distal intramural spread of rectal cancer after preoperative radiotherapy: the results of a multicenter randomized clinical study., Int. J. Radiat. Oncol. Biol. Phys., 2006, 65, 1, 182-188, doi: 10.1016/j.ijrobp.2005.11.039.

  5. Bujko K, Nowacki MP, Nasierowska-Guttmejer A, Michalski W, Bebenek M, Kryj M, Long-term results of a randomized trial comparing preoperative short-course radiotherapy with preoperative conventionally fractionated chemoradiation for rectal cancer., Br J Surg, 2006, 93, 10, 1215-1223, doi: 10.1002/bjs.5506.

  6. Bujko K, Michalski W, Kepka L, Nowacki MP, Nasierowska-Guttmejer A, Tokar P, Dymecki D, Pawlak M, Lesniak T, Richter P, Wojnar A, Chmielik E, , Association between pathologic response in metastatic lymph nodes after preoperative chemoradiotherapy and risk of distant metastases in rectal cancer: An analysis of outcomes in a randomized trial., Int. J. Radiat. Oncol. Biol. Phys., 2007, 67, 2, 369-377, doi: 10.1016/j.ijrobp.2006.08.065.

  7. Pietrzak L, Bujko K, Nowacki MP, Kepka L, Oledzki J, Rutkowski A, Szmeja J, Kladny J, Dymecki D, Wieczorek A, Pawlak M, Lesniak T, Kowalska T, Richter P, , Quality of life, anorectal and sexual functions after preoperative radiotherapy for rectal cancer: report of a randomised trial., Radiother Oncol, 2007, 84, 3, 217-225, doi: 10.1016/j.radonc.2007.07.007.

Additional files

Editorial Notes