A Randomized Controlled Clinical Trial Comparing Oncological Results and Functional Recovery Between Laparoscopic and Open Method for the Treatment of Advanced Rectal Cancer After Concurrent Chemoradiation Therapy (CCRT)

NCT00601549 | Unknown Phase 3 DMC

• 2 other identifiers: 941007NSC96-2314-B-002-146
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This is a three-year research project. The major aims of this study are to:(1) compare the functional recovery and oncologic results in patients with advance rectal cancer treated by either traditional open or laparoscopic methods by randomized prospective clinical trials;(2) investigate the presence of tumor cells in the peripheral blood of patients undergoing either laparoscopic or open surgery; (3) searching for the clinicopathologic features of advanced rectal cancer after CCRT; (4) conduct the translational research regarding the difference of gene expression and its prognostic significance in advanced rectal cancer before and after chemoradiation therapy by micro-array analysis methods; (5) exploration of the potential stem cells of colorectal cancer using CD-133 cell surface marker.

Conditions

Rectal Cancer

Keywords

Rectal cancer; CCRT; Laparoscopic Surgery; rectal cancer can be resected by curative and elective surgery; rectal adenocarcinoma below peritoneal reflection; American Society of Anesthesiology（ASA） classⅠ to Ⅲ lesions

Outcome Measures

Primary Outcomes (1)

• Oncologic Results

  Every 6 months

Secondary Outcomes (1)

• Functional recovery of patients

  every 6 months

Study Arms (2)

1

EXPERIMENTAL

Patients with low rectal cancer after CCRT undergoing laparoscopic surgery

Procedure: Laparoscopic surgery

2

ACTIVE COMPARATOR

Patients with low rectal cancer after CCRT undergoing traditional open surgery

Procedure: Traditional open surgery

Interventions

Laparoscopic surgery PROCEDURE

Laparoscopic surgery

1

Traditional open surgery PROCEDURE

Open surgery

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rectal cancer can be resected by curative and elective surgery.
• Rectal adenocarcinoma below peritoneal reflection
• American Society of Anesthesiology（ASA） classⅠ to Ⅲ lesions

You may not qualify if:

• Cancer located at upper rectum （above peritoneal reflection）
• Distant metastasis
• Adjacent organ invasion
• Intestinal obstruction
• Past colonic surgery
• Body mass index（BMI）\>35 kg/m2
• Patients who can not complete the whole treatment protocol of concurrent chemoradiation therapy.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Division of Colorectal Surgery, Department of Surgery , National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

Related Publications (1)

• Liang JT, Huang KC, Lai HS, Lee PH, Jeng YM. Oncologic results of laparoscopic versus conventional open surgery for stage II or III left-sided colon cancers: a randomized controlled trial. Ann Surg Oncol. 2007 Jan;14(1):109-17. doi: 10.1245/s10434-006-9135-4. Epub 2006 Oct 25.

  PMID: 17066227 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jin-Tung Liang, PhD

  Division of Colorectal Surgery, Department of Surgery , National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Tung Liang, PhD

CONTACT

886-2-23123456; jintung@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 28, 2008
• Study Start: January 1, 2000
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

TW (1)