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
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
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Berlin Cancer Society (Berliner Krebsgesellschaft e.V.) (Germany)
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
Basic results (scientific)
Publication list