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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 1:1.
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 1:1. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Control group | Active Comparator | - The patients who are assigned into control group take a curative surgery within 2 weeks after successful SEMS placement. And then, after recovery period, adjuvant FOLFOX chemotherapy will be administered into them. Adjuvnat FOLFOX chemotherapy will be administered every 2week during 6 months (total 12 cycles). |
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| The Experimental group | Experimental | - The patients who are assigned into the experimental group take a neoadjuvant FOLFOX chemotherapy within 2 weeks after successful SEMS placement. After three cycles of FOLFOX, they will take a curative surgery. And then, after recovery period, adjuvant FOLFOX chemotherapy will be administered into them. Adjuvnat FOLFOX chemotherapy will be administered every 2week during about 4 months (total 9 cycles). The perioperative FOLFOX chemotherapy in the experimetal group will be totally 12 cycles during 6months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant chemotherapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival | 3-year overall survival after curative surgery | 3 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complication rate | postoperative ileus, reoperation rate, wound infection, .. | within 30 days after surgery |
| stoma formation rate | stoma formation rate withing 30 days after surgery |
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Inclusion Criteria:
iv. Colon cancer located beween distal T colon and Rectosigmoid junction colon which is defined as a tumor above 15cm from anal verge.
v. Colonocopic fiding: tumor involving whole circumference of the lumen, impossible to pass endoscope through the tumor vi. SEMS placement vii. no colonic injury and successful decompression of the colon with in 48 hours after SEMS placement.
viii. ECOG performance 0-2 ix. ASA ≤ 3 x. Appropriate function of the vital organ (acceptable liver enzyme and BUN/Cr) xi. Appropriate function of hematopoietic system (platelet ≥100,000ul, neutrophil ≥2,000ul) xii. If the patient is female in fertile period, urine hCG test is negative and she has no plan of pregnancy with 6 months after the termiation of whole treatment.
xiii. If the patient is male in fertile period, he agrees with contraception during treatment period and 6 months after the termination of whole treatment.
Exclusion Criteria:
xiv. Inappropriate function of vital organ (impaired renal function, elevated liver enzyme, and so on ) xv. Inappropriate function of hematopoietic system (platelet <100,000ul, neutrophil < 2,000ul) xvi. Genetic problem such as galactose intolerance, Lapp lactase deficiency, or glucose-galatose malabsorption)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bong-Hyeon Kye, MD., Ph.D | Contact | 82-10-32826382 | ggbong@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Bong-Hyeon Kye, MD.PhD. | The Catholic University of Korea | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32528099 | Result | Kye BH, Kim JH, Kim HJ, Lee YS, Lee IK, Kang WK, Cho HM, Ahn CH, Oh ST. The optimal time interval between the placement of self-expandable metallic stent and elective surgery in patients with obstructive colon cancer. Sci Rep. 2020 Jun 11;10(1):9502. doi: 10.1038/s41598-020-66508-6. | |
| 39901122 | Derived | Kye BH, Kim JH, Kim HJ, Lee YS, Lee IK, Kang WK, Cho HM, Park JK, Ahn CH, Lee JI, Oh ST, Choi BJ. Oncologic oUTcomes of neoadjuvant chemotherapy for obSTructive colon cAncer after steNt decompression (OUTSTAND trial); A study protocol of multicenter non-inferiority randomized controlled trial. BMC Cancer. 2025 Feb 3;25(1):194. doi: 10.1186/s12885-025-13588-0. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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The Control group
The Experimental group
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| Adjuvant chemotherapy | Drug | After the surgery, adjuvant chemotherapy will be administered, and total perioperative chemotherapy will be administered with 12 cycles. |
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| Curative resection | Procedure | After successful SEMS placement, curate resection will be performed for all enrolled patients regardless of neoadjuvant chemotherapy. |
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| within 30 days after surgery |
| pathologic result | TNM stage, lymphovascular invasion, silent perforation.... | within 30 days after surgery |
| recurrence rate | recurrent rate after curative surgery within postoperative 3 years | 3 years after surgery |
| disease-free survival | disease-free survival after curative surgery within postoperative 3 years | 3 years after surgery |
| circulating tumor DNA | to analyze the serial patterns of ctDNA in each step of treatments including stent placement, neoadjuvant therapy, surgery, and adjuvant therapy | 1year after surgery |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |