- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04084496
mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients
March 1, 2024 updated by: Yuhong Li, Sun Yat-sen University
A Phase II Study With mFOLFIRINOX as Adjuvent Chemotherapy for Resectable Pancreas Carcinoma
Although FOLFIRINOX regimen was recently presented to be effective as adjuvant chemotherapy for resectable pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating resectable pancreatic cancer patients in China.
Since for many tumors, different races may show different responses to the same regimen, we design this open phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as adjuvant chemotherapy for resectable pancreatic cancer in China.
Study Overview
Detailed Description
This is a phase II study. Patients with resectable pancreatic carcinoma will receive adjuvant chemotherapy of FOLFIRINOX for 6 months.
Primary endpoint is the disease free survival. Secondary endpoints are overall survival, safety and quality of life.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Miaozhen Qiu
- Phone Number: 13760612003 13760612003
- Email: qiumzh@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-Sen University Cancer Center
-
Contact:
- Yu-hong Li, MD, Ph D
- Email: liyh@sysucc.org.cn
-
Principal Investigator:
- Yu-hong Li, MD, Ph D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the pancreas without distant metastases.
- Receive radical resection of pancreatic cancer
- No prior cytostatic chemotherapy
- Female and male patients > 18 and <=79 years using contraception
- ECOG ≤ 1
- Patient has adequate bone marrow and organ function
- Absolute Neutrophil Count (ANC) ≥ 2.0 x 109/L Platelets ≥ 90 x 109/L Hemoglobin ≥ 90 g/L
- Patient has adequate liver function AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis) Serum bilirubin ≤ 1.2 x ULN Creatinine ≤ 1.25 times ULN
- Good compliance
- Written informed consent
Exclusion Criteria:
- Pregnant or lactating women
- Distant metastasis.
- Patients with severe gastrointestinal hemorrhage which need frequent blood transfusions.
- Refuse to take appropriate contraceptive measures (including male patients).
- Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil.
- Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases.
- Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ).
- Psychiatric illness that would prevent the patient from giving informed consent.
- Patient is concurrently using other antineoplastic agent
- Patient has used investigational antineoplastic agent within 4 weeks prior to entry.
- Known HIV-positivity.
- No history of chronic diarrhea, nausea or vomit.
- No ≥ grade 2 sensory peripheral neuropathy.
- A history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina.
- Infectious disease or inflammation with body temperature ≥ 38 ℃.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FOLFIRINOX
Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
|
Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease free survival
Time Frame: up to 24 months
|
From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first
|
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: up to 24 months
|
From the date of first drug administration until the date of death
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yuhong Li, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
September 6, 2019
First Submitted That Met QC Criteria
September 9, 2019
First Posted (Actual)
September 10, 2019
Study Record Updates
Last Update Posted (Estimated)
March 4, 2024
Last Update Submitted That Met QC Criteria
March 1, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- mFOLFIRINOX_PC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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