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

ISRCTN ISRCTN56463377
DOI https://doi.org/10.1186/ISRCTN56463377
EudraCT/CTIS number 2004-001606-27
Secondary identifying numbers N/A
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

Study website

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

Study designRandomised controlled multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titlePre-operative short-course radiotherapy versus neoadjuvant radiochemotherapy in locally advanced rectal cancer (uT2N+, uT3N-/+)
Study acronymBRCT (Berlin Rectal Cancer Trial)
Study objectivesStandard 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) studiedRectal cancer
InterventionGroup 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)5-fluorouracil (5-FU)
Primary outcome measureLocal recurrence, median follow up five years
Secondary outcome measures1. 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 study start date15/01/2004
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants760 patients (380 group one, 380 group two)
Key inclusion criteria1. 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 criteria1. 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 patient’s ability to give informed consent
Date of first enrolment15/01/2004
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Austria
  • Germany

Study participating centre

Department of Surgery and Surgical Oncology
Berlin
D-13125
Germany

Sponsor information

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

Kaiserin-Friedrich-Haus
Robert-Koch-Platz 7
Berlin
D-10115
Germany

Phone +49 (0)30 283 24 00
Email info@berliner-krebsgesellschaft.de
Website http://www.berlinerkrebsgesellschaft.de
ROR logo "ROR" https://ror.org/020yxp837

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

Editorial Notes

04/01/2021: Publication reference added.