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A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00145769
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : August 9, 2013
Sponsor:
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

Study Description
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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.

Condition or disease Intervention/treatment 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

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.
Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
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:
  • Radiation
  • RT
  • Short Course
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:
  • Radiation
  • RT
  • Long Course

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


Outcome Measures
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Primary Outcome Measures :
  1. Local recurrence [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ]
  2. Toxicity [ Time Frame: Interim analyses will occur annually. ]
  3. 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) ]
  4. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Trans Tasman Radiation Oncology Group
Australasian Gastro-Intestinal Trials Group
Colorectal Surgical Society of Australasia (CSSA)
Royal Australasian College of Surgeons (RACS)
Investigators
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Study Chair: Sam Ngan, FRANZCR Peter MacCallum Cancer Centre, Australia
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Trans Tasman Radiation Oncology Group:
rectal cancer
radiotherapy
chemotherapy
chemoradiation
adjuvant therapy
Additional relevant MeSH terms:
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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