Long-term Observational Study to Evaluate the DFS & OS of NCT06389552

Updated 06/14/2024

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number	NCT06389552
Other study ID #	IN_CTP_N01
Secondary ID
Status	Recruiting
Phase
First received
Last updated
Start date	September 25, 2023
Est. completion date	December 2027

Study information
Verified date	April 2024
Source	HK inno.N Corporation
Contact	Soyeon Ahn
Phone	82-2-6477-0252
Email	soyeon.ahn[@]inno-n.com
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial Summary

This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery.

Description:

This study is multi-center, prospective, long-term follow-up observational study.

Recruitment information / eligibility
Status	Recruiting
Enrollment	36
Est. completion date	December 2027
Est. primary completion date	December 2026
Accepts healthy volunteers	No
Gender	All
Age group	19 Years and older
Eligibility	Inclusion Criteria: - Age over 19 at the time of obtaining the informed consent form - Planning to FOLFIRINOX as adjuvant therapy after pancreatic cancer surgery - ECOG 0 or 1 - Scheduled to RO or R1 resection - Organ function capable of chemotherapy Exclusion Criteria: - FOLFIRINOX contraindications among the drug approval requirements - Palliative Therapy - Experienced toxic reactions or Hypersensitivity reactions of FOLFIRINOX

Study Design

Related Conditions & MeSH terms

Adjuvant Chemotherapy

Locations
Country	Name	City	State
Korea, Republic of	Seoul ST. Mary's Hospital	Seoul

Sponsors *(1)*
Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	Duration of survival before pancreatic cancer recurrence or death	Day 1 to Week 88
Secondary	Overall survival	Duration of overall survival	Day 1 to Week 88

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT05613465` - Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo	N/A
	Terminated	`NCT03702868` - Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer
	Recruiting	`NCT03748680` - IMPROVE Intervention Trial Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer	Phase 2
	Completed	`NCT03079427` - Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma	Phase 2
	Withdrawn	`NCT03228043` - Apatinib for Resectable Colorectal Cancer	N/A
	Recruiting	`NCT03468010` - A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pelvic or Para-aortic Node Involvement)	Phase 3
	Recruiting	`NCT03199989` - Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)	Phase 3
	Completed	`NCT03213444` - Impact of Adjuvant Chemotherapy in Patients With Colon Cancer	N/A
	Terminated	`NCT04070313` - A Phase II Study of S-1 Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer in Taiwan	Phase 2
	Recruiting	`NCT05735145` - Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer	Phase 3
	Terminated	`NCT02492477` - TOP-TRIAL Safety of Not Flushing Non-used PORT-A-CATH® in Cancer Patients	Phase 1
	Completed	`NCT02312284` - Observational Study on the Patients With Rectal Cancer	N/A
	Active, not recruiting	`NCT04564157` - New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy	Phase 3
	Recruiting	`NCT03448549` - SOX Versus XELOX as Adjuvant Chemotherapy for Stage III Colorectal Cancer Patients	Phase 3
	Not yet recruiting	`NCT01261962` - Modulation of Immune Response by Oral Zinc Supplementation in Chemotherapy for Colon Cancer	N/A
	Recruiting	`NCT01125020` - Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation	N/A
	Terminated	`NCT03858166` - Efficacy and Safety of PEG-rhG-CSF Secondary Prophylaxis vs. Therapeutic Administration in Patients With Ovarian Cancer	Phase 4
	Not yet recruiting	`NCT04303429` - Adjuvant Chemotherapy in High Risk Stage II Colon Cancer	Phase 3
	Recruiting	`NCT03748485` - Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis	N/A