|
Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer Clinical research trials and Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer. Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer  Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer
Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer
For Condition: stage 1 rectal cancer,stage 3 rectal cancer,stage 2 rectal cancer
Status: Recruiting
Sponsor(s): NMRC International Colorectal Cancer Trials Group ,
Synopsis: 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: Randomizedphase III trial to compare the effectiveness of two types of surgery in treating patients who have rectal cancer.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HeahMin, Study Chair, National Cancer Centre - Singapore
Minimally Invasive and Endoscopic Surgery Centre *Recruiting*
Happy Valley, ,
Hong Kong
Recruiting Samuel Kwok 852-2835-8698
National Cancer Centre - Singapore *Recruiting*
Singapore, , 169608
Singapore
Recruiting Francis Seow-Choen 65-6321-4677
Pamela Youde Nethersole Eastern Hospital *Recruiting*
Hong Kong, ,
China
Recruiting Michael Li 852-2595-6389
Additional Information:
Study ID Numbers: CDR0000068354; EU-99019,NMRC-ICR01
Study Start Date:
Record last reviewed: January 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007930
Other Stage 3 Rectal Cancer Studies:
1. Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
2. Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
3. Lymph Node Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I, Stage II, or Stage III Colorectal Cancer
4. Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer
5. Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
Related Studies:
Other stage 3 rectal cancer Clinical Trials
Other Clinical Trials
Other Happy Valley Clinical Trials
Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer
|
|
|
|
|
|
|
|
