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

ISRCTN	ISRCTN56463377
DOI	https://doi.org/10.1186/ISRCTN56463377
Clinical Trials Information System (CTIS)	2004-001606-27
Protocol serial number	N/A
Sponsor	Berlin Cancer Society (Berliner Krebsgesellschaft e.V.) (Germany)
Funder	Berlin Cancer Society (Berliner Krebsgesellschaft e.V.) (Germany)

Submission date: 25/05/2007
Registration date: 02/07/2007
Last edited: 04/01/2021

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

Not provided at time of registration

Contact information

Prof Peter M Schlag
Scientific

Department of Surgery and Surgical Oncology
Charité-Universitätsmedizin Berlin
Campus Berlin-Buch
Lindenberger Weg 80
Berlin
D-13125
Germany

Email	pmschlag@charite.de

Study information

Primary study design	Interventional
Study design	Randomised controlled multicentre trial
Secondary study design	Randomised controlled trial
Scientific title	Pre-operative short-course radiotherapy versus neoadjuvant radiochemotherapy in locally advanced rectal cancer (uT2N+, uT3N-/+)
Study acronym	BRCT (Berlin Rectal Cancer Trial)
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	5-fluorouracil (5-FU)
Primary outcome measure(s)	Local recurrence, median follow up five years
Key secondary outcome measure(s)	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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	760
Key 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)
Key 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
Date of first enrolment	15/01/2004
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Austria
Germany

Study participating centre

Department of Surgery and Surgical Oncology

Berlin
D-13125
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	06/02/2009	04/01/2021	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/01/2021: Publication reference added.