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

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN56463377
• Date of registration: 02/07/2007
• Prospective Registration: No
• Primary sponsor: Berlin Cancer Society (Berliner Krebsgesellschaft e.V.) (Germany)
• Public title: Pre-operative short-course radiotherapy versus neoadjuvant radiochemotherapy in locally advanced rectal cancer (uT2N+, uT3N-/+)
• Date of first enrolment: 15/01/2004
• Target sample size: 760
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN56463377
• Study type: Interventional
• Study design: Randomised controlled multicentre trial (Treatment)

Countries of recruitment

Austria, Germany

Contacts

• Name: Peter M Schlag

Key inclusion & exclusion criteria

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)
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 patient?s ability to give informed consent

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Rectal cancer
Cancer
Colorectal cancer

Intervention(s)

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.

Primary Outcome(s)

Local recurrence, median follow up five years

Secondary Outcome(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

Secondary ID(s)

N/A

2004-001606-27

Source(s) of Monetary Support

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