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)

This study is currently recruiting participants.
Verified December 2012 by National Taiwan University Hospital
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00601549
First received: January 15, 2008
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Procedure: Laparoscopic surgery
Procedure: Traditional open surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Oncologic Results [ Time Frame: Every 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Functional recovery of patients [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: January 2000
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients with low rectal cancer after CCRT undergoing laparoscopic surgery
Procedure: Laparoscopic surgery
Laparoscopic surgery
Active Comparator: 2
Patients with low rectal cancer after CCRT undergoing traditional open surgery
Procedure: Traditional open surgery
Open surgery

Detailed Description:

With the progress of medical technology, the minimally invasive laparoscopic colorectal surgery is currently enthusiastically performed in the medical center all over the world. Because preoperative CCRT can induce fibrosis of pelvic tissues, most colorectal surgeons have been hesistant to apply the laparoscopic approach to the resection of irradiated rectal cancer. However, based on our preliminary experience(Liang et al. Dis Colon Rectum Sep,2005), we found that if rectal cancers were resected by laparoscopic approach, the advantages include better visualization of anatomical structures such as paired hypogastric nerves, presacral fascia, lateral ligament, seminal vesicles and middle hemorrhoidal artery, as compared to traditional open method. Moreover, the conduction of laparoscopic double-stapling technique or pull-through procedure was not jeopardized by CCRT even when the pelvis is narrow in male patient. That is, with the current surgical technique, we feel that laparoscopic procedure is feasible and safe for inrradiated rectal cancers. Because the application of this technique in the resection of rectal cancer after CCRT is not reported before and has academic importance, it is mandatory for us to conduct this randomized prospective study. Remarkably, some objective surgical stress-related factors including CD4+/CD8+, ESR, CRP, and IL-6 (both in serum and intra-peritoneal surgical wounds), and the presence of cancer cells in either laparoscopic and open group of patients were analyzed and compared. Moreover, the translational research regarding the expression of genes and their prognostic significance before and after chemoradiation therapy have been scarce. In this project, we plan to explore the influence of chemo radiation therapy on the gene expression by microarray analysis according to the reproducible experiences developed by our colleagues in the research of gastric cancer (JCO 2005;23:7286-95). Initially, we will focus on the expression difference of the commonly mentioned genes related to the chemosensitivity of colorectal cancer, including mismatch repair genes, thymidylate synthetase, Dipyrimidine dehydrogenase (DPD), and epidermal growth factor receptor (EGFR), and then extend to the screening of the whole genome. Moreover, some recent reports indicated that the cell population harboring CD-133 were ther potential colorectal cancer stem cells. In this project, we will also explore the changes of histopathology and CD-133 cellular population in advanced rectal cancer after CCRT.

Because this is a randomized prospective clinical trial, it is uneasy to accrue enough patients. According to the statistical estimation, at least 558 patients should be recruited and randomized to either traditional open group and laparoscopic group to reach a statistical significance. Moreover, it has been reported that in order to represent the overall survival, the patients have to be followed up for at least 3 years after treatment. Therefore, it is necessary that this project should be further conducted for at least 3 years. Based on our preliminary results in the previous 2-year conduction of this project, we found that laparoscopic technique facilitated patients with rectal cancer after CCRT less surgical invasiveness, faster postoperative recovery, similar extent of dissection and the number of harvested lymph nodes, and did not increase of tumor dissemination during surgical manipulation, as compared with traditional open surgery. This encouraging results inspired us to complete this 3-year project, with a view to enhancing the academic reputation of Taiwan Colorectal Surgery and the quality of clinical management for patients with rectal cancer.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601549

Contacts
Contact: Jin-Tung Liang, PhD 886-2-23123456 ext 5683 jintung@ntu.edu.tw

Locations
Taiwan
Division of Colorectal Surgery, Department of Surgery , National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jin-Tung Liang, PhD    886-2-23123456 ext 5683    jintung@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Jin-Tung Liang, PhD Division of Colorectal Surgery, Department of Surgery , National Taiwan University Hospital
  More Information

Publications:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00601549     History of Changes
Other Study ID Numbers: 941007, NSC96-2314-B-002-146
Study First Received: January 15, 2008
Last Updated: December 5, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
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

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

ClinicalTrials.gov processed this record on April 16, 2014