A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
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ClinicalTrials.gov Identifier: NCT00145769 |
Recruitment Status :
Completed
First Posted : September 5, 2005
Last Update Posted : August 9, 2013
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Condition or disease | Intervention/treatment | Phase |
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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 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 326 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum |
Study Start Date : | July 2001 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | May 2011 |
Arm | Intervention/treatment |
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Active Comparator: Short Course Radiotherapy
Short Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy
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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:
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Active Comparator: Long Course Radiotherapy
Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy
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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.
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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 |
- Local recurrence [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ]
- Survival [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ]
- Toxicity [ Time Frame: 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. [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ]
- 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) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145769

Study Chair: | Sam Ngan, FRANZCR | Peter MacCallum Cancer Centre, Australia |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Trans Tasman Radiation Oncology Group |
ClinicalTrials.gov Identifier: | NCT00145769 |
Other Study ID Numbers: |
TROG 01.04 NHMRC 209123 ( Other Grant/Funding Number: National Health Medical and Research Council ) |
First Posted: | September 5, 2005 Key Record Dates |
Last Update Posted: | August 9, 2013 |
Last Verified: | August 2013 |
rectal cancer radiotherapy chemotherapy chemoradiation adjuvant therapy |
Adenocarcinoma Rectal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Colorectal Neoplasms Intestinal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |