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

NCT00145769 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2013-08-09

No results posted yet for this study

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.

Conditions

  • Adenocarcinoma of Rectum

Interventions

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.

RADIATION

Long Course Radiotherapy

50.4 Gy delivered in 1.8 Gy fractions over 5 1/2 weeks.

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

Sponsors & Collaborators

  • Australasian Gastro-Intestinal Trials Group

    collaborator NETWORK

  • Colorectal Surgical Society of Australasia (CSSA)

    collaborator UNKNOWN

  • Royal Australasian College of Surgeons (RACS)

    collaborator UNKNOWN

  • Trans Tasman Radiation Oncology Group

    lead OTHER

Principal Investigators

  • Sam Ngan, FRANZCR · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2009-06-30
Completion
2011-05-31

Countries

  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00145769 on ClinicalTrials.gov