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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by National Cancer Center, Korea.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Seung Yong Jeong, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00470951
First received: May 7, 2007
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Rectal Cancer
Procedure: open rectal resection
Procedure: laparoscopic rectal resection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anorectal function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 year, 5 year ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: preop, postop 3mo, posop 1 yr, 3yr, 5yr ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Immunologic response [ Time Frame: preop, postop 2hr, postop 1day, 5day ] [ Designated as safety issue: No ]

Estimated Enrollment: 340
Study Start Date: April 2006
Estimated Study Completion Date: August 2014
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470951

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

No publications provided by National Cancer Center, Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seung Yong Jeong, Professor, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00470951     History of Changes
Other Study ID Numbers: NCCCTS-06-179
Study First Received: May 7, 2007
Last Updated: August 16, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by 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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014