Concurrent Chemoradiation Versus Wide Pelvic Lymphadenectomy for Advanced Rectal Cancer

NCT00154752 | Unknown Phase 3

• 1 other identifier: 9100013841
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Rectal cancer, CCRT, Pelvic lymphadenoectomy.

Outcome Measures

Primary Outcomes (1)

• oncologic results

Secondary Outcomes (1)

• functional results

Interventions

CCRT, Pelvic lymphadenoectomy. PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Tung Liang, M.D., Ph.D.

CONTACT

886-2-23562068; jintung@ha.mc.ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 1999
• Study Completion: June 1, 2005
• Last Updated: November 22, 2005

Record last verified: 1999-01

Locations

TW (1)