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| Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer |
| Link to the ClinicalTrials.gov record | Information obtained from ClinicalTrials.gov on February 23, 2012 |
| Title of trial/grant title | Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer |
| Current status of trial | Active, not recruiting |
| Sponsors and collaborators | National Cancer Center, Korea |
| Information provided by | National Cancer Center, Korea |
| ClinicalTrials.gov identifier | NCT00470951 |
| 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(s) | Rectal Cancer |
| Intervention(s) | Procedure: open rectal resection Procedure: Laproscopic rectal resection |
| Phase | Phase III |
| Study type and 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 |
| Further study details | 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, Hyo Seong Choi, Seok-Byung Lim, Sung Bum Kang 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 estimated 3yr-DFS:75%, survival difference: 10% power = 0.90, significance level=0.05, 10% expected loss of F/U 304 + 30 = 334 -> 340 2. Disease free survival Kaplan-Meier method Log-rank test 3. QOL and anorectal function Mean and 95% confidence interval 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 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 Long-term outcomes Primary end point Disease free survival (3 years after surgery) Secondary end points Time to recurrence Overall survival Port-site and wound site recurrence Metastasis 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) |
| Primary outcome | disease free survival 3 years Yes |
| Secondary outcome | quality of life and anorectal function 1 year No |
| Study start | April 2006 |
| Minimum age | 18 Years |
| Maximum age | 80 Years |
| Gender | Both |
| Eligibility 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 |
| Study chairs or principal investigators | Jae Hwan Oh, M.D., ph.D., Principal Investigator, National Cancer Center, Korea |
| Locations | Gyeonggi, Korea, Republic of National Cancer Center, Korea Goyang Gyeonggi 410-769 |
| Study ID numbers | NCCCTS-06-179 |
| Last updated | March 29, 2010 |
| Record first received | May 7, 2007 |
| ClinicalTrials.gov identifier | NCT00470951 |
| Download date | Information obtained from ClinicalTrials.gov on February 23, 2012 |
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