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mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

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ClinicalTrials.gov Identifier: NCT04084496
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Yuhong Li, Sun Yat-sen University

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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 : September 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 24 months ]
    From the date of first drug administration until the date of death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ℃.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084496


Contacts
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Contact: Miaozhen Qiu 13760612003 ext 13760612003 qiumzh@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Yu-hong Li, MD, Ph D       liyh@sysucc.org.cn   
Principal Investigator: Yu-hong Li, MD, Ph D         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yuhong Li Sun Yat-sen University

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Responsible Party: Yuhong Li, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04084496     History of Changes
Other Study ID Numbers: mFOLFIRINOX_PC
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Yuhong Li, Sun Yat-sen University:
pancreatic cancer
adjuvant chemotherapy
FOLFIRINOX
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases