A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
This study has been completed.
Sponsor:
Trans-Tasman Radiation Oncology Group (TROG)
Collaborators:
Australasian Gastro-Intestinal Trials Group
Colorectal Surgical Society of Australasia (CSSA)
Royal Australasian College of Surgeons (RACS)
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00145769
First received: September 2, 2005
Last updated: August 7, 2013
Last verified: August 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of Rectum |
Drug: Short Course Adjuvent Chemotherapy Drug: Long Course Adjuvant Chemotherapy Radiation: Short Course Radiotherapy Radiation: Long Course Radiotherapy Drug: Concurrent Chemotherapy Procedure: Initial Surgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum |
Resource links provided by NLM:
Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):
Primary Outcome Measures:
- Local recurrence [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Survival [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: Interim analyses will occur annually. ] [ Designated as safety issue: Yes ]
- Abdominoperineal resection rate. This is defined as the proportion of all patients in any arm who undergo operation by abdominalperineal resection. [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ] [ Designated as safety issue: No ]
| Enrollment: | 326 |
| Study Start Date: | July 2001 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Short Course Radiotherapy
Short Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy
|
Drug: Short Course Adjuvent Chemotherapy
Post operative adjuvant chemotherapy: 5FU (425mg/m2) preceded by Folinic acid (20mg/m2) delivered over 5 days for 6 monthly cycles
Radiation: Short Course Radiotherapy
25 Gy in 5 fractions over 5 days.
Other Names:
|
|
Active Comparator: Long Course Radiotherapy
Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy
|
Drug: Long Course Adjuvant Chemotherapy
Post operative adjuvant 5FU (425mg/m2) preceded by folinic acid (20mg/m2) delivered over 5 days for 4 monthly cycles
Radiation: Long Course Radiotherapy
50.4 Gy delivered in 1.8 Gy fractions over 5 1/2 weeks.
Other Names:
Drug: Concurrent Chemotherapy
5FU 225mg/m2/day delivered IV over continous 7 day period for the duration of radiotherapy (5 1/2 weeks).
|
|
Active Comparator: 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.
|
Procedure: Initial Surgery
Surgery is to be performed according to the NHMRC Guidelines for the prevention, early detection and management of colorectal cancer: Elective surgery for 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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 Criteria:
- 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00145769
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145769
Locations
| Australia, Australian Capital Territory | |
| The Canberra Hospital | |
| Garran, Australian Capital Territory, Australia, 2605 | |
| Australia, New South Wales | |
| Macarthur Cancer Therapy Centre | |
| Campbelltown, New South Wales, Australia, 2560 | |
| Royal Prince Alfred Hospital | |
| Camperdown, New South Wales, Australia, 2050 | |
| Liverpool Hospital | |
| Liverpool, New South Wales, Australia, 1871 | |
| Newcastle Mater Misericordiae Hospital | |
| Newcastle, New South Wales, Australia, 2310 | |
| Nepean Cancer Care Centre | |
| Penrith, New South Wales, Australia, 2751 | |
| Prince of Wales Hospital | |
| Randwick, New South Wales, Australia, 2031 | |
| Royal North Shore Hospital | |
| Sydney, New South Wales, Australia, 2069 | |
| Riverina Cancer Care Centre | |
| Wagga Wagga, New South Wales, Australia, 2650 | |
| Westmead Hospital | |
| Wentworthville, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Mater Private Hospital | |
| Brisbane, Queensland, Australia | |
| Royal Brisbane Hospital | |
| Herston, Queensland, Australia, 4029 | |
| Mater QRI | |
| South Brisbane, Queensland, Australia, 4101 | |
| North Queensland Oncology Service | |
| Townsville, Queensland, Australia, 4810 | |
| East Coast Cancer Centre | |
| Tugun, Queensland, Australia, 4224 | |
| Princess Alexandra Hospital | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Australia, South Australia | |
| Royal Adelaide Hospital | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Tasmania | |
| Launceston General Hospital | |
| Launceston, Tasmania, Australia, 7250 | |
| Australia, Victoria | |
| Peter MacCallum Cancer Centre | |
| Bendigo, Victoria, Australia | |
| Box Hill Hospital | |
| Box Hill, Victoria, Australia | |
| Monash Medical Centre | |
| East Bentleigh, Victoria, Australia, 3165 | |
| Peter MacCallum Cancer Centre | |
| East Melbourne, Victoria, Australia, 3002 | |
| St Vincents Melbourne | |
| Fitzroy, Victoria, Australia | |
| Western Hospital | |
| Footscray, Victoria, Australia | |
| Frankston Hospital | |
| Frankston, Victoria, Australia | |
| Andrew Love Cancer Centre, Geelong Hospital | |
| Geelong, Victoria, Australia, 3220 | |
| Peter MacCallum Cancer Centre | |
| Melbourne, Victoria, Australia, 3002 | |
| Alfred Hospital | |
| Prahran, Victoria, Australia, 3181 | |
| Murray Valley Private Hospital | |
| Wodonga, Victoria, Australia, 3690 | |
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital | |
| Nedlands, Western Australia, Australia, 6009 | |
| Royal Perth Hospital | |
| Perth, Western Australia, Australia, 6000 | |
| New Zealand | |
| Auckland Hospital | |
| Auckland, New Zealand, 1001 | |
| Waikato Hospital | |
| Hamilton, New Zealand, 3200 | |
| Wellington Hospital | |
| Wellington, New Zealand, 7902 | |
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Australasian Gastro-Intestinal Trials Group
Colorectal Surgical Society of Australasia (CSSA)
Royal Australasian College of Surgeons (RACS)
Investigators
| Study Chair: | Sam Ngan, FRANZCR | Peter MacCallum Cancer Centre, Australia |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Trans-Tasman Radiation Oncology Group (TROG) |
| ClinicalTrials.gov Identifier: | NCT00145769 History of Changes |
| Other Study ID Numbers: | TROG 01.04, NHMRC 209123 |
| Study First Received: | September 2, 2005 |
| Last Updated: | August 7, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
|
rectal cancer radiotherapy chemotherapy chemoradiation adjuvant therapy |
Additional relevant MeSH terms:
|
Adenocarcinoma Rectal Neoplasms Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases |
ClinicalTrials.gov processed this record on February 26, 2015