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Concurrent Chemoradiation Versus Wide Pelvic Lymphadenectomy for Advanced Rectal Cancer

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ClinicalTrials.gov Identifier: NCT00154752
Recruitment Status : Unknown
Verified January 1999 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : November 22, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
Based on the neurophysiology, it is well known that sympathetic nerves control the ejaculatory function and bladder neck closure. In contrast, the parasympathetic nerves control penile erection and bladder wall contraction. Because of the difference in cultural background of the patients and training background of the physicians between Western and Oriental Countries, the Western people did not believe in the efficacy of wide pelvic lymphadenectomy. In the Oriental countries, due to the shortage of standardized facilities, treatment protocol, and manpower, the concurrent preoperative chemoradiation therapy (CCRT) of American style is currently not widely accepted. Therefore, the advantage and disadvantage of these two treatment modalities for advanced rectal cancers need be further clarified. In this project, we plan to randomly assign the patients into two groups: (1) concurrent preoperative chemoradiation therapy (CCRT) + conventional surgery group; (2) wide pelvic lymphadenectomy group. Thereafter, we plan to evaluate: (1) the anorectal function by anorectal manometry and colonic transit time using radioopaque markers; (2) the micturition function using urodynamic study; (3) the penile erection by RigiScan; and (4) the ejaculatory function by clinical interview of the patients. Moreover, the various clinicopathologic factors, including the depth of tumor invasion and the status of lymph node invasion, were recorded in detail according to the guidelines recommended by the Japanese Society of Coloproctology. Furthermore, we will evaluate the oncological results for these patients.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: CCRT, Pelvic lymphadenoectomy. Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Concurrent Chemoradiation Versus Wide Pelvic Lymphadenectomy for Advanced Rectal Cancer
Study Start Date : January 1999
Study Completion Date : June 2005



Primary Outcome Measures :
  1. oncologic results

Secondary Outcome Measures :
  1. functional results


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Primary rectal adenocarcinoma below the peritoneal reflection 2. Tumor with suspected lateral nodes involvement and/or T4 lesion 3. ASA class Ⅰto Ⅲ patients 4. The life expectancy was greater than 12 weeks 5. Age of the patients between 18 and 75 years

Exclusion Criteria:

  • 1. Emergency operation 2. Primary tumors with distant metastasis or peritoneal carcinomatosis 3. Primary tumors located at other anatomical sites

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154752


Contacts
Contact: Jin-Tung Liang, M.D., Ph.D. 886-2-23562068 jintung@ha.mc.ntu.edu.tw

Locations
Taiwan
Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C. Recruiting
Taipei, Taiwan, 100
Contact: Jin-Tung Liang, M.D., Ph.D.    886-2-23562068    jintung@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jin-Tung Liang, M.D., Ph.D. Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.

ClinicalTrials.gov Identifier: NCT00154752     History of Changes
Other Study ID Numbers: 9100013841
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 22, 2005
Last Verified: January 1999

Keywords provided by National Taiwan University Hospital:
Rectal cancer, CCRT, Pelvic lymphadenoectomy.

Additional relevant MeSH terms:
Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases