Pancreatic Cancer ResectablePhase 2NCT04224402
Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
A Phase 2 study testing mFOLFORINOX in people with Pancreatic Cancer Resectable, run by Yuhong Li at 1 site in China.
Trial summary
This prospective and open-label study evaluates the efficacy and safety of mFOLFIRINOX as postoperative chemotherapy in treating Chinese patients with pancreatic cancer after R0/R1 resection. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Pancreatic Cancer Resectable
- What is being tested?
- mFOLFORINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2020to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should be voluntary to the trial and provide with signed informed consent.
- Histologically confirmed diagnosis of pancreatic cancer
- Male or female, Age: 18-79 years old.
- No recurrence or metastasis was observed from a follow-up of 4 to 8 weeks by CT scan after radical surgery.
- the value of Carbohydrate Antigen19-9(CA19-9) < 180U/mL within 12 weeks after surgery.
- No previous chemotherapy
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- Eastern Cooperative Oncology Group(ECOG) performance status of 0-1
- normal function of organ system including the followings.
- No hematologic dysfunction(Platelets ≥90×10^9/L; Neutrophil ≥2×109/L;Hemoglobin ≥90g/L).
- Serum bilirubin ≤ 1.2 × upper limits of normal(ULN); aminotransferase ≤ 5 × ULN.
- Serum creatinine ≤ 1.25× ULN, or creatinine clearance rate(CCR) ≥60mL/min(calculated by Cockcroft-Gault formula).
- ECOG scored as 0-1.
- Life expectancy > 3 months.
Who cannot join
- Patient is concurrently using other antineoplastic agent.
- Known severe hypersensitivity to drugs in the regimen.
- Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in situ).
- Evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension.
- Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.
- Evidence of active infection or active epidemic disease.
- Psychiatric illness that would prevent the patient from giving informed consent
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Trial to Investigate the Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
This prospective and open-label study evaluates the efficacy and safety of mFOLFIRINOX as postoperative chemotherapy in treating Chinese patients with pancreatic cancer after R0/R1 resection.
Read the detailed description
The patients will be treated with systemic FOLFIRINOX chemotherapy of adjusted dosage.
- Conditions
- Pancreatic Cancer Resectable
- Being tested
- mFOLFORINOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFORINOXDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| mFOLFIRINOX | Other | 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 Receives: Drug: mFOLFORINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression Free Survival
defined as the period from the date of resection to tumor relapse caused by any reason
Measured: Up to 24 months
Secondary outcomes (1)
Overall Survival
the duration from enrollment to the patient's death (all causes)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start31 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer ResectableStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuhong Li, Sun Yat-sen University
- Investigators
- Yu-hong Li, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224402
- Sponsor's protocol ID
- FOLFIRINOX-PC-Adjuvant
- Status last verified
- Feb 2023
- First submitted
- 6 Dec 2019
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial to Investigate the Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
- ClinicalTrials.gov ID
- NCT04224402
- Acronym / sponsor ID
- FOLFIRINOX-PC-Adjuvant
- Conditions
- Pancreatic Cancer Resectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yuhong LiUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Jan 2020 (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.
This prospective and open-label study evaluates the efficacy and safety of mFOLFIRINOX as postoperative chemotherapy in treating Chinese patients with pancreatic cancer after R0/R1 resection.
Detailed description
The patients will be treated with systemic FOLFIRINOX chemotherapy of adjusted dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mFOLFIRINOX | Other | Drug: mFOLFORINOXPatients 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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients should be voluntary to the trial and provide with signed informed consent.
- Histologically confirmed diagnosis of pancreatic cancer
- Male or female, Age: 18-79 years old.
- No recurrence or metastasis was observed from a follow-up of 4 to 8 weeks by CT scan after radical surgery.
- the value of Carbohydrate Antigen19-9(CA19-9) < 180U/mL within 12 weeks after surgery.
Key exclusion criteria (8 listed)
- Patient is concurrently using other antineoplastic agent.
- Known severe hypersensitivity to drugs in the regimen.
- Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in situ).
- Evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension.
- Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.
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 |
|---|---|---|
| mFOLFORINOXPatients 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. | Drug | mFOLFIRINOX |
Primary outcome
Regression Free Survival
Time frame: Up to 24 months
defined as the period from the date of resection to tumor relapse caused by any reason
1 secondary outcome
Overall Survival
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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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. This study is not recruiting at the moment.
Yu-hong Li principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mFOLFORINOX in people with Pancreatic Cancer Resectable, run by Yuhong Li at 1 site in China.
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 13 inclusion and 8 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: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression Free Survival (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.