- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04889820
Outcome of Neoadjuvant Chemotherapy for Obstructive Colon Cancer
Oncologic oUTcomes of Neoadjuvant Chemotherapy for obSTructive Colon cAncer After steNt Decompression (OUTSTAND Trial); Multicenter Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bong-Hyeon Kye, MD., Ph.D
- Phone Number: 82-10-32826382
- Email: ggbong@catholic.ac.kr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- i. Age : 20 years old or more and lesser than 75 years old ii. Agreement of this study iii. Clinical stage II or III colon cancer with colonic obstruction which is confirmed by pathologic review and imaging study.
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:
- i. any suspicious distant metastasis ii. any other primary malignant lesion iii. Clinical stage T1or T2 and N0 iv. the sign of perforation or severe ischemia requiring ememgency operation v. the complication related to SEMS placement (severe bleeding and perforation after SEMS placement) vi. ASA 4 or more vii. ECOG 3 or more viii. colonic obstruction by benign stricture ix. pregnant woman or woman who is breastfeeding x. the paitents who already enrolled into other study or are taking medicine related to any clinical trial xi. the patients who are taking sorivudine xii. the patients who are taking Tegafur/gimeracil/oteracil xiii. the patietns who have a medical history of hypersensitivity reaction to 5-FU, oxaliplatin, leucovorin,or any medication including platinum.
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: The Control group
- 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).
|
After the surgery, adjuvant chemotherapy will be administered, and total perioperative chemotherapy will be administered with 12 cycles.
Other Names:
After successful SEMS placement, curate resection will be performed for all enrolled patients regardless of neoadjuvant chemotherapy.
|
Experimental: The Experimental group
- 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.
|
After the surgery, adjuvant chemotherapy will be administered, and total perioperative chemotherapy will be administered with 12 cycles.
Other Names:
After successful SEMS placement, curate resection will be performed for all enrolled patients regardless of neoadjuvant chemotherapy.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-year overall survival
Time Frame: 3 years after surgery
|
3-year overall survival after curative surgery
|
3 years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative complication rate
Time Frame: within 30 days after surgery
|
postoperative ileus, reoperation rate, wound infection, ..
|
within 30 days after surgery
|
stoma formation rate
Time Frame: within 30 days after surgery
|
stoma formation rate withing 30 days after surgery
|
within 30 days after surgery
|
pathologic result
Time Frame: within 30 days after surgery
|
TNM stage, lymphovascular invasion, silent perforation....
|
within 30 days after surgery
|
recurrence rate
Time Frame: 3 years after surgery
|
recurrent rate after curative surgery within postoperative 3 years
|
3 years after surgery
|
disease-free survival
Time Frame: 3 years after surgery
|
disease-free survival after curative surgery within postoperative 3 years
|
3 years after surgery
|
circulating tumor DNA
Time Frame: 1year after surgery
|
to analyze the serial patterns of ctDNA in each step of treatments including stent placement, neoadjuvant therapy, surgery, and adjuvant therapy
|
1year after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bong-Hyeon Kye, MD.PhD., The Catholic University of Korea
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XC21MIDI0004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colon Cancer, Obstruction
-
Istanbul Medipol University HospitalRecruitingQuality of Life | Emergencies | Colon Cancer | Tumor ObstructionTurkey
-
Parma University HospitalFausto Catena; Gennaro PerroneRecruitingEmergencies | Diverticulitis | Colo-rectal Cancer | Intussusception | Colon Disease | Volvulus Colon | Foreign BodiesItaly
-
National Cancer Institute (NCI)NSABP Foundation IncCompletedColon Adenocarcinoma | Stage IIIA Colon Cancer AJCC v7 | Stage IIIB Colon Cancer AJCC v7 | Stage IIIC Colon Cancer AJCC v7 | Stage IIA Colon Cancer AJCC v7 | Stage IIB Colon Cancer AJCC v7 | Stage IIC Colon Cancer AJCC v7United States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
-
Gruppo Oncologico del Nord-OvestSeagen Inc.; Servier; Foundation MedicineRecruitingStage II Colon Cancer | Stage III Colon Cancer | HER2-positive Colon Cancer | RAS Wild-type Colon CancerItaly
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)CompletedFatigue | Depressive Symptoms | Stage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Psychosocial Effects of Cancer and Its Treatment | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon... and other conditionsUnited States
-
Hospital da Senhora da OliveiraCompletedColon Cancer | Colon Adenoma | Colon Polyp | Colon Rectal CancerPortugal
-
National Cancer Institute (NCI)CompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage I Colon Cancer | Stage... and other conditionsUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RecruitingStage III Colon Cancer AJCC v8 | Colon Adenocarcinoma | Microsatellite Stable Colon Carcinoma | Stage IIB Colon Cancer AJCC v8 | Stage IIC Colon Cancer AJCC v8United States
-
Howard S. Hochster, MDRecruitingStage IV Colon Cancer AJCC v8 | Stage IVA Colon Cancer AJCC v8 | Stage IVB Colon Cancer AJCC v8 | Stage IVC Colon Cancer AJCC v8 | Metastatic Colon CarcinomaUnited States
Clinical Trials on Adjuvant chemotherapy
-
Beijing Stomatological HospitalBeijing Friendship Hospital; Beijing Chao Yang Hospital; The First Affiliated... and other collaboratorsRecruitingQuality of Life | Postoperative Complications | Head and Neck NeoplasmsChina
-
Sun Yat-sen UniversityUnknown
-
Shanghai Zhongshan HospitalRecruitingSurgery | Resectable Pancreatic Cancer | Adjuvant ChemoradiotherapyChina
-
Zhejiang Cancer HospitalRecruitingGastric AdenocarcinomaChina
-
Tao OUYANGActive, not recruiting
-
Wuhan Union Hospital, ChinaWithdrawnColorectal Cancer | Liver Metastases | RadiotherapyChina
-
Dr Kundan Singh ChufalActive, not recruitingEsophageal NeoplasmAustralia, India
-
Saint Vincent's Hospital, KoreaCompleted
-
Royal Marsden NHS Foundation TrustUnknown
-
Tang-Du HospitalRecruitingCarcinoma, Non-Small-Cell Lung | Neoplasm, Residual | Circulating Tumor DNA | Next-Generation Sequencing | Chemotherapy, AdjuvantChina