ISRCTN - ISRCTN56463377: Pre-operative short-course radiotherapy versus neoadjuvant radiochemotherapy in locally advanced rectal cancer (uT2N+, uT3N-/+)

Plain English Summary

Not provided at time of registration

Trial website

http://www.rrk-berlin.de/rrkweb/chirurgie/cco/forschung/forschungsschwerpunkte/Rektumstudie.pdf

Contact information

Type

Scientific

Primary contact

Prof Peter M Schlag

ORCID ID

Contact details

Department of Surgery and Surgical Oncology
Charité-Universitätsmedizin Berlin
Campus Berlin-Buch
Lindenberger Weg 80
Berlin
D-13125
Germany
-
pmschlag@charite.de

Additional identifiers

EudraCT number

2004-001606-27

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Pre-operative short-course radiotherapy versus neoadjuvant radiochemotherapy in locally advanced rectal cancer (uT2N+, uT3N-/+)

Acronym

BRCT (Berlin Rectal Cancer Trial)

Study hypothesis

Standard treatment for locally advanced cancer of the rectum is pre-operative short-course radiotherapy or combined neoadjuvant radiochemotherapy with 5-fluorouracil (5-FU) plus post-operative chemotherapy with 5-FU. Similar long-term survival, local control and late morbidity have been reported for both these methods in non-comparative studies. In addition to other ongoing comparative trials we include a larger number of patients for adequate power and we avoid the adjuvant treatment bias by mandatory adjuvant chemotherapy in both groups. It is our hypothesis that the rate of local recurrence after five years is 12% in pre-operative short-course radiotherapy and 7% in combined radiochemotherapy.

Ethics approval

Approved by the Ethics Committee of the Charité and the responsible authorities. Certified and recommended by the German Gancer Society ("Gütesiegel A") on the 29th September 2003 (ref: AA3/03/38; EudraCT-number: 2004-001606-27).

Study design

Randomised controlled multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Rectal cancer

Intervention

Group one: receiving pre-operative short-course radiotherapy (five times 5 Gy) followed by total mesorectal excision (TME) and adjuvant continous 5-FU infusion therapy for 12 weeks.
Group two: receiving neoadjuvant combined radiochemotherapy (50.4 Gy and continuous 5-FU) followed by TME and adjuvant continous 5-FU infusion therapy for 12 weeks.

Intervention type

Drug

Phase

Not Specified

Drug names

5-fluorouracil (5-FU)

Primary outcome measure

Local recurrence, median follow up five years

Secondary outcome measures

1. Overall survival, median follow up five years
2. Disease-free survival, median follow up five years
3. Complete resection rate (R0 resection): measured at the date of surgery of the last patient entered
4. Rate of sphincter saving resection: measured at the date of surgery of the last patient entered
5. Acute and late toxicity (radiation related side effects), median follow up five years
6. Quality of life including long term bowel function, median follow up five years

Overall trial start date

15/01/2004

Overall trial end date

31/12/2009

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Karnofsky Index 80% or better
3. Histological diagnosis of adeno- or mucinous carcinoma of rectum
4. Primary rectal cancer:
4.1. Maximum 12 cm above dentate line (upper limit)
4.2. Staged T2N+ or T3N0 or T3N+ (by endorectal ultrasound or computed tomography [CT]/magnetic resonance imaging [MRI] scan)
5. No evidence of metastatic disease as determined by chest X-ray and abdominal ultrasound (or CT-scan of chest and abdomen or other investigations such as positron emission tomography [PET] scan or biopsy if required)
6. Adequate bone marrow function with platelets more than 100 x 10^9/l and neutrophils more than 2.0 x 10^9/l
8. Creatinine clearance more than 50 ml/min
7. Serum bilirubin less than 2.0 x upper limit of institutional normal range (ULN)

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

760 patients (380 group one, 380 group two)

Participant exclusion criteria

1. Rectal cancer other than adeno- or mucinous carcinoma
2. Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
3. Patients with locally advanced inoperable disease, such as T4-tumour
4. Presence of metastatic disease or recurrent rectal tumour
5. Any previous chemotherapy or radiotherapy, and any investigational treatment for rectal cancer
6. Concurrent uncontrolled medical conditions
7. Pregnancy or breast feeding
8. Clinically significant (i.e., active) cardiac disease (e.g., congestive heart failure, symptomatic coronary artery) or myocardial infarction within the last six months
9. Stenotic tumour which can not be passed by the colonoscope and pre-operative need of diverting stoma
10. Evidence of hereditary colorectal cancer (hereditary non-polyposis colorectal cancer [HNPCC] and familial adenomatous polyposis [FAP])
11. Medical or psychiatric conditions that compromise the patients ability to give informed consent

Recruitment start date

15/01/2004

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Austria, Germany

Trial participating centre

Department of Surgery and Surgical Oncology
Berlin
D-13125
Germany

Sponsor information

Organisation

Berlin Cancer Society (Berliner Krebsgesellschaft e.V.) (Germany)

Sponsor details

Kaiserin-Friedrich-Haus
Robert-Koch-Platz 7
Berlin
D-10115
Germany
+49 (0)30 283 24 00
info@berliner-krebsgesellschaft.de