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mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

Primary Purpose

Pancreatic Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Folfirinox

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, adjuvant chemotherapy, FOLFIRINOX

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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 ℃.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FOLFIRINOX

Arm Description

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.

Outcomes

Primary Outcome Measures

Disease free survival

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

From the date of first drug administration until the date of death

Full Information

NCT ID

NCT04084496

First Posted

September 6, 2019

Last Updated

February 14, 2023

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04084496

Brief Title

mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

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.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

pancreatic cancer, adjuvant chemotherapy, FOLFIRINOX

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FOLFIRINOX

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Folfirinox

Intervention Description

Primary Outcome Measure Information:

Title

Disease free survival

Description

From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first

Time Frame

up to 24 months

Secondary Outcome Measure Information:

Title

Overall survival

Description

From the date of first drug administration until the date of death

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 ℃.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Miaozhen Qiu

Phone

13760612003

Ext

13760612003

qiumzh@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuhong Li

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yu-hong Li, MD, Ph D

liyh@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Yu-hong Li, MD, Ph D

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

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