The Finnish Rectal Cancer Study
| 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
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
Scientific
Alkutie 81a
Helsinki
00660
Finland
| sinikka.salmenkyla@fimnet.fi |
Study information
| Study design | Randomized prospective multicenter trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A 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 objectives | Total 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) studied | Rectal cancer |
| Intervention | After 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 type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 5-fluorouracil, leucovorin |
| Primary outcome measure | 1. 5 year survival 2. 5 year local recurrence rate |
| Secondary outcome measures | Postoperative complications |
| Overall study start date | 01/01/1995 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 280 |
| Key inclusion criteria | 1. Aged 18 - 80 years 2. Clinical stage II-III primary rectal adenocarcinoma |
| Key exclusion criteria | 1. 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 enrolment | 01/01/1995 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- Finland
Study participating centre
00660
Finland
Sponsor information
Hospital/treatment centre
PL340
Helsinki
00290
Finland
| Website | http://www.hus.fi/ |
|---|---|
"ROR" |
https://ror.org/02e8hzf44 |
Funders
Funder type
Hospital/treatment centre
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 |
Editorial Notes
20/04/2017: Plain English summary added.
