Condition category
Cancer
Date applied
23/02/2012
Date assigned
09/07/2012
Last edited
20/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.hus.fi/

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

Publication citations

Additional files

Editorial Notes

20/04/2017: Plain English summary added.