Status:
COMPLETED
A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
Australasian Gastro-Intestinal Trials Group
Colorectal Surgical Society of Australasia (CSSA)
Conditions:
Adenocarcinoma of Rectum
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multi-centre randomised trial comparing long course (LC) preoperative chemoradiation with short course (SC) preoperative radiotherapy for patients with localised T3 rectal cancer.
Detailed Description
Objective: * The objective is, in patients with T3 clinically resectable carcinoma of the rectum, to demonstrate that the local recurrence rate in patients treated with a long course (LC) of pre-oper...
Eligibility Criteria
Inclusion
- All of the following must apply:
- Pathologically documented and clinically resectable adenocarcinoma of the rectum.
- The patient must be considered by the surgeon to be suitable for a curative resection.
- The patient must be considered by the radiation oncologist to have no contraindication to pre-operative radiotherapy.
- Clinical T3 stage tumour on endorectal ultrasound or MRI. When endorectal ultrasound cannot be performed satisfactorily due to a technical reason, such as stenosis or proximity of the tumour, and MRI is not available, infiltration of perirectal fat on CT scan is also acceptable.
- Tumour with lower border within 12 cm from anal verge on rigid sigmoidoscopy.
- ECOG performance status 0, 1 or 2.
- Adequate bone marrow function with neutrophil count at least 1.5 x 109/L and platelet count at least 100 x 109/L.
- Adequate liver function with bilirubin and alanine aminotransferase (ALT) \<= 1.5 times the upper limit of normal.
- Adequate renal function with serum creatinine \<= 1.5 times the upper limit of normal.
- Accessibility for treatment and follow-up.
- Written informed consent.
Exclusion
- None of the following must apply:
- Evidence of distant metastases.
- Recurrent rectal cancer.
- Unstable cardiac disease or clinically significant active infection.
- Other cancer in the last 5 years except treated non-melanoma skin cancer or carcinoma in situ of the cervix.
- Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures.
- Contraindication to insertion of a suitable indwelling venous catheter e.g. implantable central venous device (infuse-a-port), Hickman catheter or peripherally inserted central catheter.
- Prior pelvic or abdominal radiotherapy.
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT00145769
Start Date
July 1 2001
End Date
May 1 2011
Last Update
August 9 2013
Active Locations (34)
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1
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
2
Macarthur Cancer Therapy Centre
Campbelltown, New South Wales, Australia, 2560
3
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
4
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871