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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

Tracking Information
First Submitted Date  ICMJE September 2, 2005
First Posted Date  ICMJE September 5, 2005
Last Update Posted Date August 9, 2013
Study Start Date  ICMJE July 2001
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2007)
Local recurrence [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
- Local recurrence
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2007)
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2005)
  • - Survival
  • - Toxicity
  • - Abdominoperineal resection rate
  • - Quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
Official Title  ICMJE A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenocarcinoma of Rectum
Intervention  ICMJE
  • 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
  • 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: Short Course Radiotherapy
    25 Gy in 5 fractions over 5 days.
    Other Names:
    • Radiation
    • RT
    • Short Course
  • 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).
  • 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
Study Arms  ICMJE
  • Active Comparator: Short Course Radiotherapy
    Short Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy
    Interventions:
    • Drug: Short Course Adjuvent Chemotherapy
    • Radiation: Short Course Radiotherapy
  • Active Comparator: Long Course Radiotherapy
    Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy
    Interventions:
    • Drug: Long Course Adjuvant Chemotherapy
    • Radiation: Long Course Radiotherapy
    • Drug: Concurrent Chemotherapy
  • 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.
    Intervention: Procedure: Initial Surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2009)
326
Original Enrollment  ICMJE
 (submitted: September 2, 2005)
325
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00145769
Other Study ID Numbers  ICMJE TROG 01.04
NHMRC 209123 ( Other Grant/Funding Number: National Health Medical and Research Council )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Trans Tasman Radiation Oncology Group
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Trans Tasman Radiation Oncology Group
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Australasian Gastro-Intestinal Trials Group
  • Colorectal Surgical Society of Australasia (CSSA)
  • Royal Australasian College of Surgeons (RACS)
Investigators  ICMJE
Study Chair: Sam Ngan, FRANZCR Peter MacCallum Cancer Centre, Australia
PRS Account Trans Tasman Radiation Oncology Group
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP