A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Trans-Tasman Radiation Oncology Group (TROG).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
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:
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00145769
First received: September 2, 2005
Last updated: September 29, 2009
Last verified: September 2009
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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: SC Adjuvent Chemotherapy Drug: LC Adjuvant Chemotherapy Radiation: SC Radiotherapy Radiation: LC 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 |
| Estimated Study Completion Date: | December 2010 |
| 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: SC Adjuvent Chemotherapy
Post operative adjuvant chemotherapy: 5FU (425mg/m2) preceded by Folinic acid (20mg/m2) delivered over 5 days for 6 monthly cycles
Radiation: SC 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: LC Adjuvant Chemotherapy
Post operative adjuvant 5FU (425mg/m2) preceded by folinic acid (20mg/m2) delivered over 5 days for 4 monthly cycles
Radiation: LC 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
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: | Associate Professor Sam Ngan, 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: | September 29, 2009 |
| 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 Adenocarcinoma, Mucinous Rectal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013