RecruitingPhase 2NCT06249321

mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer Refractory to Chemotherapy


Sponsor

Fudan University

Enrollment

30 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to Patients with CA19-9-normal Advanced Pancreatic Cancer refractory to chemotherapy.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining a chemotherapy regimen called mFOLFIRINOX with radiotherapy can help people with advanced pancreatic cancer who have specific normal tumor marker levels (normal CA19-9) and have already received prior chemotherapy without success. Normal CA19-9 pancreatic cancers can behave differently and this study explores targeted treatment for them. **You may be eligible if...** - You are between 18 and 80 years old - You have confirmed advanced pancreatic cancer - You have normal CA19-9, CEA, and CA125 blood marker levels - Your cancer has not responded to at least one prior chemotherapy regimen - You have not previously received radiotherapy for this cancer - Your cancer can be measured on scans - You are in reasonably good physical condition **You may NOT be eligible if...** - Your CA19-9 is elevated - You have already had radiotherapy - You have not tried chemotherapy first - You have severe organ function problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGmFOLFIRINOX plus IMRT

Chemotherapy will be administered according to the newest edition of National Comprehensive Cancer Network (NCCN) guideline and a modified FOLFIRINOX regimen will be the first choice. Patients with advanced pancreatic adenocarcinoma will receive the modified FOLFIRINOX regimen (oxaliplatin \[70 mg per square meter of body surface area\], irinotecan \[130 mg per square meter\], leucovorin \[200 mg per square meter\], and fluorouracil \[2000 mg per square meter\] every 2 weeks). Four-week chemotherapy is considered as a cycle. Patients will be recommended to receive Intensity-Modulated Radiation Therapy (IMRT) after about 2\~6 cycles of chemotherapy. The following treatment after radiotherapy will be applied according to the newest edition of NCCN guideline.


Locations(1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06249321


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