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
Contact information
Prof Peter M Schlag
Scientific
Scientific
Department of Surgery and Surgical Oncology
Charité-Universitätsmedizin Berlin
Campus Berlin-Buch
Lindenberger Weg 80
Berlin
D-13125
Germany
| pmschlag@charite.de |
Study information
| Study design | Randomised controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 15/01/2004 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 760 patients (380 group one, 380 group two) |
| 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
D-13125
Germany
Sponsor information
Berlin Cancer Society (Berliner Krebsgesellschaft e.V.) (Germany)
Research organisation
Research organisation
Kaiserin-Friedrich-Haus
Robert-Koch-Platz 7
Berlin
D-10115
Germany
| Phone | +49 (0)30 283 24 00 |
|---|---|
| info@berliner-krebsgesellschaft.de | |
| Website | http://www.berlinerkrebsgesellschaft.de |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
04/01/2021: Publication reference added.
