A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum - Full Text View

Sponsors and Collaborators:	Trans-Tasman Radiation Oncology Group (TROG) Australasian Gastro-Intestinal Trials Group Colorectal Surgical Society of Australasia (CSSA) Royal Australasian College of Surgeons (RACS)
Information provided by:	Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:	NCT00145769

Purpose

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	Intervention	Phase
Adenocarcinoma of Rectum	Drug: 5-fluorouracil Drug: folinic acid Procedure: radiotherapy Procedure: surgery	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Liothyronine sodium Triiodothyronine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum

Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:

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:

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) ]

Enrollment:	325
Study Start Date:	July 2001
Estimated Study Completion Date:	June 2009

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145769

Locations

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

Sponsors and Collaborators

Trans-Tasman Radiation Oncology Group (TROG)

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

More Information

Click here for more information about this study on the TROG official website This link exits the ClinicalTrials.gov site

Publications:

Kapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van Krieken JH, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med. 2001 Aug 30;345(9):638-46. Summary for patients in: Can J Surg. 2003 Feb;46(1):54-6. Med J Aust. 2002 Nov 18;177(10):563-4.

Folkesson J, Birgisson H, Pahlman L, Cedermark B, Glimelius B, Gunnarsson U. Swedish Rectal Cancer Trial: long lasting benefits from radiotherapy on survival and local recurrence rate. J Clin Oncol. 2005 Aug 20;23(24):5644-50.

Ngan SY, Fisher R, Burmeister BH, Mackay J, Goldstein D, Kneebone A, Schache D, Joseph D, McKendrick J, Leong T, McClure B, Rischin D. Promising results of a cooperative group phase II trial of preoperative chemoradiation for locally advanced rectal cancer (TROG 9801). Dis Colon Rectum. 2005 Jul;48(7):1389-96.

Study ID Numbers:	TROG 01.04, NHMRC 209123
Study First Received:	September 2, 2005
Last Updated:	May 8, 2007
ClinicalTrials.gov Identifier:	NCT00145769
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):

rectal cancer
radiotherapy
chemotherapy
chemoradiation
adjuvant therapy

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Rectal neoplasm

Carcinoma
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Vitamins
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009