Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-09-22
First Post:
2021-05-12
Brief Title:
Outcome of Neoadjuvant Chemotherapy for Obstructive Colon Cancer
Sponsor:
The Catholic University of Korea
Organization:
The Catholic University of Korea
Study Overview
Official Title:
Oncologic oUTcomes of Neoadjuvant Chemotherapy for obSTructive Colon cAncer After steNt Decompression OUTSTAND Trial Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study patients with obstructive colon cancer will be divided into two groups in the control group curative surgery will be performed within 2 weeks after successful SEMS placement and in the experimental group 3 cycles of neoadjuvant chemotherapy will be administered into patients who undergo successful SEMS placement and then curative surgery will be performed after neoadjuvnat chemotherapy After the surgery adjuvant chemotherapy will be administered and total perioperative chemotherapy will be administered with 12 cycles The primary end points is overall survival also the short-term perioperative outcomes and long-term oncological outcomes will be compared between the control and experimental group Random allocation will be carried out with the consent of patients and their guardians after successful SEMS placement and 204 patients will be distributed between the two groups by 11
Detailed Description:
It is known that approximately 30-40 of colorectal cancer require emergency surgery Of these the colonic obstruction accounts for 80 of situations requiring emergency treatment and colon perforation appears in 20 In patients with colorectal cancer patients who require emergency surgery there are higher postoperative complication rates mortality rates and ostomy formation rate than those who do not In aspect of oncologic outcomes long-term survival also appears to be worse in patients undergoing emergency surgery Despite recent active screening for colorectal cancer some studies have reported that the proportion of colorectal cancer obstruction and perforation requiring emergency surgery still occur as before However research on treatments to reduce postoperative complications and to increase long-term survival for patients with symptomatic colorectal cancer requiring emergency surgery remains inadequate
Emergency surgery cannot be avoided when colorectal perforation occurs due to colorectal cancer Obstructive colorectal cancer has also traditionally been performed in emergency surgery with colorectal resection and ostomy composition However with the development of endoscopic equipment and technology endoscopic stent self-expandable metallic stent SEMS insertion has been feasible for patients with obstructive colon cancer and many researches about a bridge to surgery which means a surgery after adequate decompression and bowel lavage using SEMS placement have been reported that a bridge to surgery can reduce postoperative complications stoma formation and postoperative mortality in selective cases Currently such studies recommend the use of SEMS to improve short-term postoperative outcomes However in aspect of long-term oncological outcomes the results have not yet been established
In this study patients with obstructive colon cancer will be divided into two groups in the control group curative surgery will be performed within 2 weeks after successful SEMS placement and in the experimental group 3 cycles of neoadjuvant chemotherapy will be administered into patients who undergo successful SEMS placement and then curative surgery will be performed after neoadjuvnat chemotherapy After the surgery adjuvant chemotherapy will be administered and total perioperative chemotherapy will be administered with 12 cycles The primary end points is overall survival also the short-term perioperative outcomes and long-term oncological outcomes will be compared between the control and experimental group Random allocation will be carried out with the consent of patients and their guardians after successful SEMS placement and 204 patients will be distributed between the two groups by 11 Through this study we would like to identify that neoadjuvant chemotherapy followed by curative resection after successful SEMS placement for obstructive colon cancer can bring the improvement of short-term perioperative outcome and long-term oncological outcome
Emergency surgery cannot be avoided when colorectal perforation occurs due to colorectal cancer Obstructive colorectal cancer has also traditionally been performed in emergency surgery with colorectal resection and ostomy composition However with the development of endoscopic equipment and technology endoscopic stent self-expandable metallic stent SEMS insertion has been feasible for patients with obstructive colon cancer and many researches about a bridge to surgery which means a surgery after adequate decompression and bowel lavage using SEMS placement have been reported that a bridge to surgery can reduce postoperative complications stoma formation and postoperative mortality in selective cases Currently such studies recommend the use of SEMS to improve short-term postoperative outcomes However in aspect of long-term oncological outcomes the results have not yet been established
In this study patients with obstructive colon cancer will be divided into two groups in the control group curative surgery will be performed within 2 weeks after successful SEMS placement and in the experimental group 3 cycles of neoadjuvant chemotherapy will be administered into patients who undergo successful SEMS placement and then curative surgery will be performed after neoadjuvnat chemotherapy After the surgery adjuvant chemotherapy will be administered and total perioperative chemotherapy will be administered with 12 cycles The primary end points is overall survival also the short-term perioperative outcomes and long-term oncological outcomes will be compared between the control and experimental group Random allocation will be carried out with the consent of patients and their guardians after successful SEMS placement and 204 patients will be distributed between the two groups by 11 Through this study we would like to identify that neoadjuvant chemotherapy followed by curative resection after successful SEMS placement for obstructive colon cancer can bring the improvement of short-term perioperative outcome and long-term oncological outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None