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

PHASE3CompletedINTERVENTIONAL
Enrollment

326

Participants

Timeline

Start Date

July 31, 2001

Primary Completion Date

June 30, 2009

Study Completion Date

May 31, 2011

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

Trial Locations (34)

1001

Auckland Hospital, Auckland

1871

Liverpool Hospital, Liverpool

2031

Prince of Wales Hospital, Randwick

2050

Royal Prince Alfred Hospital, Camperdown

2069

Royal North Shore Hospital, Sydney

2145

Westmead Hospital, Wentworthville

2310

Newcastle Mater Misericordiae Hospital, Newcastle

2560

Macarthur Cancer Therapy Centre, Campbelltown

2605

The Canberra Hospital, Garran

2650

Riverina Cancer Care Centre, Wagga Wagga

2751

Nepean Cancer Care Centre, Penrith

3002

Peter MacCallum Cancer Centre, East Melbourne

Peter MacCallum Cancer Centre, Melbourne

3165

Monash Medical Centre, East Bentleigh

3181

Alfred Hospital, Prahran

3200

Waikato Hospital, Hamilton

3220

Andrew Love Cancer Centre, Geelong Hospital, Geelong

3690

Murray Valley Private Hospital, Wodonga

4029

Royal Brisbane Hospital, Herston

4101

Mater QRI, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

4224

East Coast Cancer Centre, Tugun

4810

North Queensland Oncology Service, Townsville

5000

Royal Adelaide Hospital, Adelaide

6000

Royal Perth Hospital, Perth

6009

Sir Charles Gairdner Hospital, Nedlands

7250

Launceston General Hospital, Launceston

7902

Wellington Hospital, Wellington

Unknown

Mater Private Hospital, Brisbane

Peter MacCallum Cancer Centre, Bendigo

Box Hill Hospital, Box Hill

St Vincents Melbourne, Fitzroy

Western Hospital, Footscray

Frankston Hospital, Frankston

All Listed Sponsors
collaborator

Australasian Gastro-Intestinal Trials Group

NETWORK

collaborator

Colorectal Surgical Society of Australasia (CSSA)

UNKNOWN

collaborator

Royal Australasian College of Surgeons (RACS)

UNKNOWN

lead

Trans Tasman Radiation Oncology Group

OTHER

NCT00145769 - A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum | Biotech Hunter | Biotech Hunter