Clinical trial NCT04084496: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
adjuvant chemotherapy
FOLFIRINOX
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 ℃.

Primary outcomes:
measure: Disease free survival
timeFrame: up to 24 months
Secondary outcomes:
measure: Overall survival
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yuhong Li
role: PRINCIPAL_INVESTIGATOR
References: