A Randomized Trial Comparing Concurrent Chemoradiation Versus Wide Pelvic Lymphadenectomy for Advanced Rectal Cancer
Sponsor study identifier
interventional
200
1 country
1
Study Start
January 1999
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
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January 1999
Date type not reportedThis date has not been verified as actual or estimated.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 8, 2005
Actual (reported)September 12, 2005
Actual (reported)oncologic results
functional results
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Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.
Taipei, 100, Taiwan
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.
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
January 1999
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
June 2005
Date type not reportedContact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Last Updated
November 22, 2005
Record last verified: 1999-01
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