Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 and over	Other	NMRC-ICR01 EU-99019, NCT00007930

Objectives

1. Compare local and distant recurrences in patients with mid-rectal cancer treated with wide mesorectal surgical excision with straight colorectal anastomosis versus total mesorectal surgical excision with colonic J pouch coloanal anastomosis.
2. Compare the functional, physiological, and anatomical outcomes in these patients treated with these two surgical procedures.
3. Compare disease-free survival and overall survival in these patients treated with these two surgical procedures.

Entry Criteria

Disease Characteristics:

• Clinical diagnosis of rectal cancer by colonoscopy or barium enema
  • Distal margin of tumor arises within 9-15 cm from the anal verge as measured by rigid sigmoidoscopy



• No synchronous multiple adenocarcinomas



• Candidate for low anterior surgical resection by laparoscopy or conventional open method



• No evidence of gross metastatic disease



• No evidence of peritoneal or pelvic metastases

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Neoadjuvant or adjuvant chemoradiotherapy allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• See Chemotherapy

Surgery:

• See Disease Characteristics

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• At least 6 months

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other malignancy within the past 5 years

Expected Enrollment

A minimum of 800 patients (400 per arm) will be accrued for this study.

Outcomes

Local recurrence at 3 years

Disease-free and overall survival at 5 years

Outline

This is a randomized, multicenter study. Patients are stratified according to treatment center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo surgical resection with a wide mesorectal excision followed by a straight colorectal anastomosis.



• Arm II: Patients undergo surgical resection with a total mesorectal excision followed by a colonic J pouch coloanal anastomosis. Patients then receive a temporary ileostomy which is closed 6 weeks later.

Patients are followed at 6 weeks, every 4-6 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

NMRC International Colorectal Cancer Trials Group

Heah Sieu Min, MD, Protocol chair		Ph: 65-6526-5247

China
	Hong Kong
	Pamela Youde Nethersole Eastern Hospital
		Michael K.W. Li, FRCS, FHKAM	Ph:  852-2595-6389
			Email: mkwli@ha.org.hk
Hong Kong
	Happy Valley
	Hong Kong Sanatorium & Hospital
		Samuel Kwok, MD	Ph:  852-2899-2217
			Email: samuelpykwok@gmail.com
Republic of Singapore
	Singapore
	National Cancer Centre - Singapore
		Heah Sieu Min, MD	Ph:  65-6526-5247

Registry Information
Official Title		Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer
Trial Start Date		1999-08-01
Registered in ClinicalTrials.gov		NCT00007930
Date Submitted to PDQ		2000-10-25
Information Last Verified		2006-12-01

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