Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer

Rectal Cancer Clinical Trial

— CTS-179  

Official title:

A Comparison for Laparoscopically Assisted and Open Surgery for Advanced Rectal Cancer After Preoperative Chemoradiation- Randomized Prospective Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00470951
• Other study ID #: NCCCTS-06-179
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 7, 2007
• Last updated: August 16, 2012
• Start date: April 2006
• Est. completion date: August 2014

Study information

• Verified date: August 2012
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 340
• Est. completion date: August 2014
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• open rectal resection
open rectal resection
• laparoscopic rectal resection
laparoscopic assisted rectal resection

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunologic response		preop, postop 2hr, postop 1day, 5day	No
Primary	Disease free survival		3 years	Yes
Secondary	Anorectal function		1 year	No
Secondary	Overall survival		3 year, 5 year	Yes
Secondary	Quality of life		preop, postop 3mo, posop 1 yr, 3yr, 5yr	No