NCT00007930

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P50-P75 for phase_3 colorectal-cancer

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

August 26, 2013

Status Verified

December 1, 2006

First QC Date

January 6, 2001

Last Update Submit

August 23, 2013

Conditions

Colorectal Cancer

Keywords

stage I rectal cancerstage II rectal cancerstage III rectal cancer

Outcome Measures

Primary Outcomes (1)

  • Local recurrence at 3 years

Secondary Outcomes (1)

  • Disease-free and overall survival at 5 years

Interventions

conventional surgeryPROCEDURE
laparoscopic surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Hong Kong Sanatorium & Hospital

Hong Kong, China

RECRUITING

Pamela Youde Nethersole Eastern Hospital

Hong Kong, China

RECRUITING

National Cancer Centre - Singapore

Singapore, 169608, Singapore

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsRectal Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Heah Sieu Min, MD

    National Cancer Centre, Singapore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

August 1, 1999

Last Updated

August 26, 2013

Record last verified: 2006-12

Locations

SG(1)CN(2)