ISRCTN ISRCTN27293422
DOI https://doi.org/10.1186/ISRCTN27293422
Secondary identifying numbers N/A
Submission date
23/02/2012
Registration date
09/07/2012
Last edited
20/04/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Rectal cancer (cancer of the rectum) affects the lower part of the large bowel that connects to the anus. Total mesorectal excision (TME) is a common procedure used in the treatment of rectal cancer in which a significant length of the bowel around the cancer is removed. The introduction of TME surgery has reduced local relapses (where the cancer comes back) but recurrence still remains a clinical problem. Preoperative radiotherapy (before surgery) to shrink the cancer has an effect but a survival benefit has been seen in only one study. These studies were conducted in the era of conventional surgery. The aim of this study is to find out whether preoperative short-term radiotherapy can reduce local recurrence with TME surgery and whether postoperative adjuvant chemotherapy (after surgery) would lead to improved survival rates.

Who can participate?
Patients aged 18-80 with rectal cancer

What does the study involve?
Participants randomly allocated to be treated with either TME surgery only or radiotherapy followed by TME surgery in 1 week or less. Radiotherapy is given on 5 consecutive days. Postoperative chemotherapy consists of six cycles and begins 4-6 weeks after surgery. All participants are followed up for at least five years after surgery to assess survival and recurrence rates.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Helsinki University Hospital (Finland)

When is the study starting and how long is it expected to run for?
January 1995 to June 2011

Who is funding the study?
Helsinki University Hospital (Finland)

Who is the main contact?
Mrs Sinikka Salmenkylä
sinikka.salmenkyla@fimnet.fi

Contact information

Mrs Sinikka Salmenkylä
Scientific

Alkutie 81a
Helsinki
00660
Finland

Email sinikka.salmenkyla@fimnet.fi

Study information

Study designRandomized prospective multicenter trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA prospective randomized multicenter trial to compare the results of combined short-term preoperative radiotherapy, postoperative 5-FU based chemotherapy and total mesorectal excision with total mesorectal excision alone in the treatment of resectable rectal cancer
Study objectivesTotal mesorectal excision (TME) and short term preoperative radiotherapy together with postoperative chemotherapy leads to better 5 year survival and lower local recurrence rate than TME alone.
Ethics approval(s)Ethics board of Helsinki University Hospital, 20/12/1994
Health condition(s) or problem(s) studiedRectal cancer
InterventionAfter informed consent had been received patients were randomized at the Finnish Cancer Registry. The randomization process was a true one, no blocks were used. The randomization was done between surgery only and 5x5Gy radiotherapy followed by surgery in one week or less. Radiotherapy was given from 3-4 fields on 5 consecutive days.

Postoperative chemotherapy consisted of bolus 5-fluorouracil (5-FU) treatment in the beginning of the study and intravenous infusion towards the end of the study. Chemotherapy consisted of six cycles and was begun 4-6 weeks after surgery. All patients were followed up at least five years after surgery.

Radiotherapy: 25 gy (5x5Gy), 4 fields, 5 cm craniocaudal margins, 3 cm anteroposterior and lateral margins. Time interval between radiotherapy and surgery not more than 7 days.

Surgery: Total mesorectal excision with mobilisation of splenic flexure. Choice between anterior resection or abdominoperineal excision in low tumours made at the operation. Diversion recommended.

Chemotherapy: 3-10 weeks after surgery at 350mg/m2 5-FU intravenous bolus on 5 consecutive days + 20mg/m2 leucovorin immeadiately before 5-FU. Six cycles, interval 3-4 weeks.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)5-fluorouracil, leucovorin
Primary outcome measure1. 5 year survival
2. 5 year local recurrence rate
Secondary outcome measuresPostoperative complications
Overall study start date01/01/1995
Completion date30/06/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants280
Key inclusion criteria1. Aged 18 - 80 years
2. Clinical stage II-III primary rectal adenocarcinoma
Key exclusion criteria1. Obstructive tumours
2. Tumours invading adjacent organs
3. Patients with a diagnosis of another cancer less than five years previously, with ulcerative colitis
4. Crohn´s disease
5. Familial polyposis
6. Hereditary nonpolypotic colorectal carcinoma
Date of first enrolment01/01/1995
Date of final enrolment30/06/2011

Locations

Countries of recruitment

  • Finland

Study participating centre

Alkutie 81a
Helsinki
00660
Finland

Sponsor information

Helsinki University Hospital (Finland)
Hospital/treatment centre

PL340
Helsinki
00290
Finland

Website http://www.hus.fi/
ROR logo "ROR" https://ror.org/02e8hzf44

Funders

Funder type

Hospital/treatment centre

Helsinki University Hospital (Finland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

20/04/2017: Plain English summary added.