Status:
UNKNOWN
Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 o...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00470951
Start Date
April 1 2006
End Date
August 1 2014
Last Update
August 17 2012
Active Locations (1)
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1
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea, 410-769