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

August 7, 2013 updated by: Trans Tasman Radiation Oncology Group
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

326

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Macarthur Cancer Therapy Centre
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Liverpool, New South Wales, Australia, 1871
        • Liverpool Hospital
      • Newcastle, New South Wales, Australia, 2310
        • Newcastle Mater Misericordiae Hospital
      • Penrith, New South Wales, Australia, 2751
        • Nepean Cancer Care Centre
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Sydney, New South Wales, Australia, 2069
        • Royal North Shore Hospital
      • Wagga Wagga, New South Wales, Australia, 2650
        • Riverina Cancer Care Centre
      • Wentworthville, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia
        • Mater Private Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater QRI
      • Townsville, Queensland, Australia, 4810
        • North Queensland Oncology Service
      • Tugun, Queensland, Australia, 4224
        • East Coast Cancer Centre
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Launceston General Hospital
    • Victoria
      • Bendigo, Victoria, Australia
        • Peter MacCallum Cancer Centre
      • Box Hill, Victoria, Australia
        • Box Hill Hospital
      • East Bentleigh, Victoria, Australia, 3165
        • Monash Medical Centre
      • East Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Centre
      • Fitzroy, Victoria, Australia
        • St Vincents Melbourne
      • Footscray, Victoria, Australia
        • Western Hospital
      • Frankston, Victoria, Australia
        • Frankston Hospital
      • Geelong, Victoria, Australia, 3220
        • Andrew Love Cancer Centre, Geelong Hospital
      • Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Centre
      • Prahran, Victoria, Australia, 3181
        • Alfred Hospital
      • Wodonga, Victoria, Australia, 3690
        • Murray Valley Private Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • New Zealand
      • Auckland, New Zealand, 1001
        • Auckland Hospital
      • Hamilton, New Zealand, 3200
        • Waikato Hospital
      • Wellington, New Zealand, 7902
        • Wellington Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)
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.
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)
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)
Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trans Tasman Radiation Oncology Group

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (ESTIMATE)

September 5, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2013

Last Update Submitted That Met QC Criteria

August 7, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TROG 01.04
  • NHMRC 209123 (OTHER_GRANT: National Health Medical and Research Council)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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