Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Sinikka Salmenkylä
ORCID ID
Contact details
Alkutie 81a
Helsinki
00660
Finland
-
sinikka.salmenkyla@fimnet.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Ethics board of Helsinki University Hospital, 20/12/1994
Study design
Randomized prospective multicenter trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
5-fluorouracil, leucovorin
Primary outcome measures
1. 5 year survival
2. 5 year local recurrence rate
Secondary outcome measures
Postoperative complications
Overall trial start date
01/01/1995
Overall trial end date
30/06/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 - 80 years
2. Clinical stage II-III primary rectal adenocarcinoma
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
280
Participant 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
Recruitment start date
01/01/1995
Recruitment end date
30/06/2011
Locations
Countries of recruitment
Finland
Trial participating centre
Alkutie 81a
Helsinki
00660
Finland
Sponsor information
Organisation
Helsinki University Hospital (Finland)
Sponsor details
PL340
Helsinki
00290
Finland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Helsinki University Hospital (Finland)
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