Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
NCT Number: NCT04224402
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.
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Notify Me18 year–79 year
All sexes
Interventional
Phase 2
Guangzhou, Guangdong, 510060, China
The patients will be treated with systemic FOLFIRINOX chemotherapy of adjusted dosage.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 24 months
defined as the period from the date of resection to tumor relapse caused by any reason
Time frame: Up to 24 months
the duration from enrollment to the patient's death (all causes)
Time frame: Up to 12 weeks
number of patients with adverse events and severity according to NCI Common Toxicity Criteria(CTC) 3.0
Time frame: Up to 24 weeks
Quality of life will be assessed at each study using EORTC QLQ-C30
Yuhong Li
Other
Phase 2 Trial to Investigate the Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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