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

Phase 3
18 Years
80 Years
Open (Enrolling)
Rectal Cancer

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Trial Information

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

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Disease free survival

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jae Hwan Oh, M.D., ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

April 2006

Completion Date:

August 2014

Related Keywords:

  • Rectal Cancer
  • rectal cancer
  • laparoscopic assisted resection
  • open resection
  • preoperative chemoradiation
  • randomized trial
  • Rectal Neoplasms