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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00154752 |
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 | Intervention | Phase |
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Colorectal Cancer |
Procedure: CCRT, Pelvic lymphadenoectomy. |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial Comparing Concurrent Chemoradiation Versus Wide Pelvic Lymphadenectomy for Advanced Rectal Cancer |
Estimated Enrollment: | 200 |
Study Start Date: | January 1999 |
Estimated Study Completion Date: | June 2005 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jin-Tung Liang, M.D., Ph.D. | 886-2-23562068 | jintung@ha.mc.ntu.edu.tw |
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 |
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. |
Study ID Numbers: | 9100013841 |
Study First Received: | September 8, 2005 |
Last Updated: | November 21, 2005 |
ClinicalTrials.gov Identifier: | NCT00154752 History of Changes |
Health Authority: | Taiwan: Department of Health |
Rectal cancer, CCRT, Pelvic lymphadenoectomy. |
Rectal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases |
Rectal Neoplasm Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms |
Colonic Diseases Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |