A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
- Conditions
- Adenocarcinoma of Rectum
- Interventions
- Drug: Short Course Adjuvent ChemotherapyDrug: Long Course Adjuvant ChemotherapyProcedure: Initial SurgeryRadiation: Short Course RadiotherapyRadiation: Long Course RadiotherapyDrug: Concurrent Chemotherapy
- Registration Number
- NCT00145769
- Lead Sponsor
- Trans Tasman Radiation Oncology Group
- 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-operative radiotherapy with continuous infusion 5-FU is lower than that in patients treated with a short course (SC) of pre-operative radiotherapy with early surgery
Eligibility Criteria:
* The main eligibility criteria are that the patient has clinically resectable adenocarcinoma of the rectum, a clinical stage T3 tumour whose lower border is within 12 cm of the anal verge, and no evidence of distant metastases.
Endpoints:
* Primary endpoint is local recurrence.
* Secondary endpoints are overall survival, toxicity, abdminoperineal resection rate, quality of life.
Treatment arms:
* SC arm: Radiotherapy (RT) 25 Gy in 5 fr in 1 week to be followed by surgery within 1 week and 6 cycles of postoperative chemotherapy 5FU/Folinic acid.
* LC arm: RT 50.4 Gy in 28 fr in 5½weeks with 5FU 225 mg/m2/day throughout the course of RT, to be followed by surgery 4-6 weeks after completion of RT. 4 cycles of adjuvant 5FU/Folinic acid will be given.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 326
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Short Course Radiotherapy Short Course Adjuvent Chemotherapy Short Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy Short Course Radiotherapy Short Course Radiotherapy Short Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy Long Course Radiotherapy Long Course Adjuvant Chemotherapy Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy Long Course Radiotherapy Long Course Radiotherapy Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy Long Course Radiotherapy Concurrent Chemotherapy Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy Surgery Initial Surgery Patients will receive initial surgery followed by post-operative management according to the NHMRC Guidelines for the prevention, early detection and management of colorectal cancer: Adjuvant therapy for rectal cancer.
- Primary Outcome Measures
Name Time Method Local recurrence Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)
- Secondary Outcome Measures
Name Time Method Survival Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) Toxicity Interim analyses will occur annually. Abdominoperineal resection rate. This is defined as the proportion of all patients in any arm who undergo operation by abdominalperineal resection. Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) Quality of life Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)
Trial Locations
- Locations (32)
Macarthur Cancer Therapy Centre
🇦🇺Campbelltown, New South Wales, Australia
Royal North Shore Hospital
🇦🇺Sydney, New South Wales, Australia
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Royal Brisbane Hospital
🇦🇺Herston, Queensland, Australia
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Newcastle Mater Misericordiae Hospital
🇦🇺Newcastle, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
East Coast Cancer Centre
🇦🇺Tugun, Queensland, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Alfred Hospital
🇦🇺Prahran, Victoria, Australia
The Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Nepean Cancer Care Centre
🇦🇺Penrith, New South Wales, Australia
Riverina Cancer Care Centre
🇦🇺Wagga Wagga, New South Wales, Australia
Mater Private Hospital
🇦🇺Brisbane, Queensland, Australia
Westmead Hospital
🇦🇺Wentworthville, New South Wales, Australia
Launceston General Hospital
🇦🇺Launceston, Tasmania, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Auckland Hospital
🇳🇿Auckland, New Zealand
Monash Medical Centre
🇦🇺East Bentleigh, Victoria, Australia
Wellington Hospital
🇳🇿Wellington, New Zealand
Mater QRI
🇦🇺South Brisbane, Queensland, Australia
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
Waikato Hospital
🇳🇿Hamilton, New Zealand
St Vincents Melbourne
🇦🇺Fitzroy, Victoria, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Andrew Love Cancer Centre, Geelong Hospital
🇦🇺Geelong, Victoria, Australia
Murray Valley Private Hospital
🇦🇺Wodonga, Victoria, Australia
North Queensland Oncology Service
🇦🇺Townsville, Queensland, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Western Hospital
🇦🇺Footscray, Victoria, Australia