Clinical trial NCT00007930: Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer
Official title: Randomized Trial of Wide Mesorectal Excision Versus Total Mesorectal Excision for Mid Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Surgery to remove the tumor may be an effective treatment for rectal cancer. It is not yet known whether one type of surgery is more effective than another for rectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two types of surgery in treating patients who have rectal cancer.

Detailed description: OBJECTIVES:

* 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.
* Compare the functional, physiological, and anatomical outcomes in these patients treated with these two surgical procedures.
* Compare disease-free survival and overall survival in these patients treated with these two surgical procedures.

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.

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

Eligibility 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

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Neoadjuvant or adjuvant chemoradiotherapy allowed

Endocrine therapy:

* Not specified

Radiotherapy:

* See Chemotherapy

Surgery:

* See Disease Characteristics

Primary outcomes:
measure: Local recurrence at 3 years
Secondary outcomes:
measure: Disease-free and overall survival at 5 years
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Hong Kong Sanatorium & Hospital
city: Hong Kong
country: China
facility: Pamela Youde Nethersole Eastern Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre - Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Heah Sieu Min, MD
role: STUDY_CHAIR
References: