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)

December 5, 2012 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • Division of Colorectal Surgery, Department of Surgery , National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oncologic Results
Time Frame: Every 6 months
Every 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional recovery of patients
Time Frame: every 6 months
every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: Jin-Tung Liang, PhD, Division of Colorectal Surgery, Department of Surgery , National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 15, 2008

First Submitted That Met QC Criteria

January 25, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 941007
  • NSC96-2314-B-002-146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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