Colon Cancer, ObstructionNCT04889820
Outcome of Neoadjuvant Chemotherapy for Obstructive Colon Cancer
A study testing Neoadjuvant chemotherapy, Adjuvant chemotherapy and Curative resection in people with Colon Cancer, Obstruction, run by The Catholic University of Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Colon Cancer, Obstruction
- What is being tested?
- Neoadjuvant chemotherapy, Adjuvant chemotherapy and Curative resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Colon cancer located beween distal T colon and Rectosigmoid junction colon which is defined as a tumor above 15cm from anal verge.
- 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.
- 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.
- If the patient is male in fertile period, he agrees with contraception during treatment period and 6 months after the termination of whole treatment.
Who cannot join
- 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.
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Oncologic oUTcomes of Neoadjuvant Chemotherapy for obSTructive Colon cAncer After steNt Decompression (OUTSTAND Trial); Multicenter Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Colon Cancer, Obstruction
- Being tested
- Neoadjuvant chemotherapy, Adjuvant chemotherapy, Curative resection
- Medical subject headings
- Colonic Neoplasms, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapyDrug
Also called Curative surgery
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.
Adjuvant chemotherapyDrug
Also called curative surgery
After the surgery, adjuvant chemotherapy will be administered, and total perioperative chemotherapy will be administered with 12 cycles.
Curative resectionProcedure or surgery
After successful SEMS placement, curate resection will be performed for all enrolled patients regardless of neoadjuvant chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Adjuvant chemotherapy; Procedure: Curative resection |
| 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. Receives: Drug: Neoadjuvant chemotherapy; Drug: Adjuvant chemotherapy; Procedure: Curative resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival
3-year overall survival after curative surgery
Measured: 3 years after surgery
Secondary outcomes (6)
postoperative complication rate
postoperative ileus, reoperation rate, wound infection, ..
Measured: within 30 days after surgery
stoma formation rate
stoma formation rate withing 30 days after surgery
Measured: within 30 days after surgery
pathologic result
TNM stage, lymphovascular invasion, silent perforation....
Measured: within 30 days after surgery
recurrence rate
recurrent rate after curative surgery within postoperative 3 years
Measured: 3 years after surgery
disease-free survival
disease-free survival after curative surgery within postoperative 3 years
Measured: 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
Measured: 1year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon Cancer, ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. 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). 2. 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.
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kye Bong-Hyeon, The Catholic University of Korea
- Investigators
- Bong-Hyeon Kye, MD.PhD., Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889820
- Sponsor's protocol ID
- XC21MIDI0004
- Status last verified
- Sep 2021
- First submitted
- 12 May 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32528099Kye 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.
PubMed 39901122
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncologic oUTcomes of Neoadjuvant Chemotherapy for obSTructive Colon cAncer After steNt Decompression (OUTSTAND Trial); Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04889820
- Acronym / sponsor ID
- XC21MIDI0004
- Conditions
- Colon Cancer, Obstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. 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). 2. 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.
| Arm | Type | Receives |
|---|---|---|
| The Control group | Active comparator | Drug: Adjuvant chemotherapy, Procedure: Curative resection- 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). |
| The Experimental group | Experimental | Drug: Neoadjuvant chemotherapy, Drug: Adjuvant chemotherapy, Procedure: Curative resection- 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. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Colon cancer located beween distal T colon and Rectosigmoid junction colon which is defined as a tumor above 15cm from anal verge.
- 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.
- 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.
- If the patient is male in fertile period, he agrees with contraception during treatment period and 6 months after the termination of whole treatment.
Key exclusion criteria (2 listed)
- 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.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant chemotherapyAlso: Curative surgeryIn 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. | Drug | The Experimental group |
| Adjuvant chemotherapyAlso: curative surgeryAfter the surgery, adjuvant chemotherapy will be administered, and total perioperative chemotherapy will be administered with 12 cycles. | Drug | The Control group, The Experimental group |
| Curative resectionAfter successful SEMS placement, curate resection will be performed for all enrolled patients regardless of neoadjuvant chemotherapy. | Procedure or surgery | The Control group, The Experimental group |
Primary outcome
3-year overall survival
Time frame: 3 years after surgery
3-year overall survival after curative surgery
6 secondary outcomes
postoperative complication rate
Time frame: within 30 days after surgery
stoma formation rate
Time frame: within 30 days after surgery
pathologic result
Time frame: within 30 days after surgery
recurrence rate
Time frame: 3 years after surgery
disease-free survival
Time frame: 3 years after surgery
circulating tumor DNA
Time frame: 1year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Results publication: PubMed 32528099Kye 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.
- Derived from this study: PubMed 39901122Kye 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bong-Hyeon Kye, MD.PhD. principal investigator
The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
A study testing Neoadjuvant chemotherapy, Adjuvant chemotherapy and Curative resection in people with Colon Cancer, Obstruction, run by The Catholic University of Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bong-Hyeon Kye, MD., Ph.D (82-10-32826382, ggbong@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year overall survival (time frame: 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889820, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.