mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04084496

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: Folfirinox	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study With mFOLFIRINOX as Adjuvent Chemotherapy for Resectable Pancreas Carcinoma

Actual Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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.	Drug: 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.

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.

Drug: Folfirinox

Outcome Measures

Primary Outcome Measures

Disease free survival [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

Secondary Outcome Measures

Overall survival [up to 24 months]
From the date of first drug administration until the date of death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 ℃.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Yuhong Li, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yuhong Li, Professor, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT04084496

Other Study ID Numbers:

mFOLFIRINOX_PC

First Posted:

Sep 10, 2019

Last Update Posted:

Sep 12, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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.:

Keywords provided by Yuhong Li, Professor, Sun Yat-sen University

pancreatic cancer

adjuvant chemotherapy

FOLFIRINOX

Additional relevant MeSH terms:

Pancreatic Neoplasms

Folfirinox

Study Results

No Results Posted as of Sep 12, 2019