Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer (CTS-179)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00470951
Recruitment Status : Unknown
Verified August 2012 by Seung Yong Jeong, National Cancer Center, Korea.
Recruitment status was:  Active, not recruiting
First Posted : May 8, 2007
Last Update Posted : August 17, 2012
Information provided by (Responsible Party):
Seung Yong Jeong, National Cancer Center, Korea

Brief Summary:
The investigators designed the randomized prospective trial of comparing open and laparoscopic resection in locally advanced rectal cancer after preoperative chemoradiation in order to determine the oncologic and functional efficacy of laparoscopic rectal resection.

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: open rectal resection Procedure: laparoscopic rectal resection Phase 3

Detailed Description:
  1. Title: A comparison for laparoscopically assisted and open surgery for advanced rectal cancer after preoperative chemoradiation - randomized prospective trial
  2. Principal investigator: Jae Hwan Oh Co-investigator: Seung Yong Jeong, Sung Bum Kang, Hyo Seong Choi, Seok-Byung Lim
  3. Purpose of the study: To compare efficacy of laparoscopic and open resection for locally advanced rectal cancer after preoperative chemoradiation
  4. Specific aims

    1. comparison of oncologic outcomes
    2. comparison of quality of life
    3. comparison of anorectal function
  5. Materials Rectal cancer <9cm from anal verge, measured by rigid sigmoidoscopy histologically proven adenocarcinoma locally advanced (T3), determined by CT, transrectal ultrasonography, MRI without any contraindication for general anesthesia,operation and chemoradiation Completion of preoperative chemoradiation
  6. Statistics

    1. Sample size calculation for non-inferiority trial: 340
    2. Disease free survival: Log-rank test,Cox regression analysis
    3. QOL and anorectal function: Repeated measured ANCOVA
  7. Methods

    1. operation time of operation : 6-8 weeks after end of preoperative chemoradiation surgical technique standard total mesorectal excision and high ligation of inferior mesenteric vessels
    2. preoperative chemoradiation chemotherapy: 2 cycles of 5-FU (400 mg/m2/day) + LV (20 mg/m2/day) IV bolus, for 3 days in 1st & 5th wks of RT or Capecitabine 825 mg/m2 p.o. bid during RT RT:45 Gy/ 25 fractions to the pelvis, 5.4 Gy/ 3 fractions boost to the primary tumor over 5.5 wks
    3. postoperative chemotherapy 4 cycles of 5-FU (400 mg/m2/day) + LV (20 mg/m2/day) IV bolus, for 5 days, 4 wks interval
    4. oncologic outcomes

      1. Short-term outcomes Surgical length of incision op time blood loss intraoperative complications conversion rate Pathological resection margins (proximal, distal, circumferential) number of harvested lymph nodes length of resected bowel tumor regression grade (Dworak's grading) TNM staging Perioperative recovery duration of use of parenteral narcotics initiation of peristalsis initiation of oral intake duration of hospital stay 30-day postoperative mortality morbidity
      2. Long-term outcomes Primary end point Disease free survival (3 years after surgery) Secondary end points Overall survival Local recurrence Distant metastasis Port-site and wound site recurrence
    5. Quality of life Urinary function Duration of urinary catheterization Residual urine volume at discharge International Prostate Symptom Score (IPSS) Male sexual function International Index of Erectile Function (IIEF) Female sexual function Female Sexual Function Index (FSFI) QOL assessment EORTC QLQ C30 EORTC QLQ CR38
    6. Anorectal function Anorectal manometry Maximum Resting Pressure Maximum Squeezing Pressure High Pressure Zone Sphincter Length Sensory Threshold Rectal Capacity Rectal Compliance Rectoanal Inhibitory Reflex Fecal Incontinence Severity Index (FISI)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison for Laparoscopically Assisted and Open Surgery for Advanced Rectal Cancer After Preoperative Chemoradiation- Randomized Prospective Trial
Study Start Date : April 2006
Actual Primary Completion Date : August 2012
Estimated Study Completion Date : August 2014

Arm Intervention/treatment
Active Comparator: open rectal resection
conventional open resection
Procedure: open rectal resection
open rectal resection
Active Comparator: laparoscopic rectal resection
laparoscopic rectal resection
Procedure: laparoscopic rectal resection
laparoscopic assisted rectal resection

Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Anorectal function [ Time Frame: 1 year ]
  2. Overall survival [ Time Frame: 3 year, 5 year ]
  3. Quality of life [ Time Frame: preop, postop 3mo, posop 1 yr, 3yr, 5yr ]

Other Outcome Measures:
  1. Immunologic response [ Time Frame: preop, postop 2hr, postop 1day, 5day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mid to low rectal cancer (within 9cm from AV, measured by RS)
  • Histologically proven adenocarcinoma
  • Locally advanced (T3, determined by CT, MRI and TRUS)
  • Completion of preoperative chemoradiation
  • Age: 18-80
  • Hb ≥ 10g/dl, WBC≥ 3,000/mm3, Plt≥ 100,000/mm3
  • Cr ≤ 1.5 mg/dl
  • Adequate cardiopulmonary function
  • Informed consent from patient or patient's relative

Exclusion Criteria:

  • Metastasis in liver, lung, brain, bone, paraaortic LN, subclavicular LN, inguinal LN
  • Second primary malignancy (except CIS of the cervix or adequately treated skin cancer or prior malignancy treated more than 5 years ago without recurrence)
  • Cardiopulmonary dysfunction
  • Active, uncontrolled infection
  • Active, uncontrolled psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00470951

Korea, Republic of
National Cancer Center, Korea
Goyang, Gyeonggi, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Principal Investigator: Jae Hwan Oh, M.D., ph.D. National Cancer Center, Korea

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Seung Yong Jeong, Professor, National Cancer Center, Korea Identifier: NCT00470951     History of Changes
Other Study ID Numbers: NCCCTS-06-179
First Posted: May 8, 2007    Key Record Dates
Last Update Posted: August 17, 2012
Last Verified: August 2012

Keywords provided by Seung Yong Jeong, National Cancer Center, Korea:
rectal cancer
laparoscopic assisted resection
open resection
preoperative chemoradiation
randomized trial

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases