Concurrent Chemoradiation Versus Wide Pelvic Lymphadenectomy for Advanced Rectal Cancer
Recruitment status was Recruiting
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Purpose
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 |
|---|---|---|
|
Colorectal Cancer |
Procedure: CCRT, Pelvic lymphadenoectomy. |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial Comparing Concurrent Chemoradiation Versus Wide Pelvic Lymphadenectomy for Advanced Rectal Cancer |
- oncologic results
- functional results
| Estimated Enrollment: | 200 |
| Study Start Date: | January 1999 |
| Estimated Study Completion Date: | June 2005 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00154752 History of Changes |
| Other Study ID Numbers: | 9100013841 |
| Study First Received: | September 8, 2005 |
| Last Updated: | November 21, 2005 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Rectal cancer, CCRT, Pelvic lymphadenoectomy. |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Colonic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013