None listed
Conditions
Interventions
Drug : Test group: mFOLFIRINOX treatment group
- mFOLFIRINOX treatment is performed at two-week intervals, and medication is continued until the disease progresses or unbearable side effects occur.
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Sponsors
Soon Chun Hyang University Hospital Cheonan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) If you clearly understand the purpose of this clinical study and give voluntary consent 2) Over 19 years old - Under 75 years old 3) Diagnosed with Neuroendocrine carcinoma (5th ed, WHO 2019); Poorly differentiated, Ki 67 20%, mitosis >20/10HPF, confirmed disease progression after etoposide/platinum therapy as first-line chemotherapy 4) If you have a lesion that can be evaluated by RECIST 1.1 (not necessarily a measurable lesion) 5) Daily living performance scale 0-1 6) When the function of bone marrow and body organs is properly maintained - Absolute neutrophils (ANC) = 1.5 x 109/L. - Hemoglobin (Hgb) = 9.0 g/dL - Platelets = 100 x 109/L. - Creatinine: less than 1.5 times the upper limit of normal or creatinine clearance (CrCl) > 30 mL/min - Total bilirubin = 2 mg/dL (Patients with biliary tract obstruction can be enrolled if they meet the criteria after adequate biliary drainage; for patients with Gilbert syndrome, total bilirubin must be <3 mg/dL.) 7) When the patient's life expectancy is more than 3 months, as judged by the investigator 8) For patients of childbearing age, patients who agree to maintain appropriate contraception.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women 2) Well differentiated neuroendocrine tumor (NET) G3 3) If 5-FU, irinotecan or oxaliplatin was used as previous treatment 4) Cases where hypersensitivity to fluoropyrimidine is suspected 5) In case of complete or partial DPD (dihydropymidine dehydrogenase) enzyme deficiency 6) When using drugs that significantly affect the blood concentration of irinotecan active metabolites (prohibited from combined use with UGT1A1 inhibitors and lapatinib, etc.) 7) If you have received cytotoxic chemotherapy within 14 days, if you have received an investigational drug in another clinical trial, if you have not received more than 2 weeks of the last dose or more than 5 times the half-life of the investigational drug, or if you have received monoclonal antibody therapy within 4 weeks 8) In case of active central nervous lesion (radiologically unstable or symptomatic brain lesion). If radiation therapy or surgical treatment has been received, registration is possible if there is evidence that the patient's condition is maintained without steroid therapy and the brain lesion disease has not progressed for more than 4 weeks. However, patients with meningeal metastasis are excluded. 9) If you have known inflammatory lung disease (pneumonitis) or interstitial lung disease 10) If the side effects of previous chemotherapy have not recovered to grade 1 or lower (excluding hair loss) 11) Radiation therapy administered to extensive lesions of more than 30% of the bone marrow within 4 weeks or limited-scope radiation therapy administered for palliative purposes within 2 weeks 12) If you have undergone major surgery within 4 weeks or have not recovered from side effects 13) Serious medical or psychiatric disease, including heart disease 14) If you have a history of other primary cancer. However, the following cancers are excluded: skin cancer other than melanoma that has been appropriately treated (basal cell or squamous cell carcinoma), superficial cervical cancer or stage 1 bladder cancer, and completely resected thyroid cancer where all treatment has been completed and there is no metastasis. (Wounds must be properly healed prior to clinical trial enrollment) 15) If, in the judgment of the researcher, the participant has symptoms or related diseases that are considered contraindicated for participation in the study (e.g. infection/inflammation; severe liver dysfunction; bilateral diffuse interstitial lung disease; uncontrolled liver disease) renal disease; unstable heart and lung disease; hemorrhagic disease; intestinal obstruction; inability to swallow oral medications; social and psychological problems, etc.) 16) Medical, mental, cognitive, or otherwise impaired in the participant's ability to understand information, provide informed consent, follow protocol procedures, or complete the clinical trial. 17) Any other person deemed unsuitable by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor evaluation, including disease progression, is evaluated according to RECIST 1.1 criteria through CT. | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Clinical examination: ECOG activity level, pulse, blood pressure, temperature, weight, physical examination ? Adverse reactions according to NCI CTCAE v5.0 standards: Among adverse reactions that are in progress when clinical trial treatment is discontinued and adverse reactions that newly occur during follow-up, adverse reactions related to clinical trial treatment are required until recovery or progression is stabilized. Record until new treatment begins. ? Clinical laboratory testing ? Hematology: Hb level, WBC count, ANC count, platelet count ? Clinical chemistry: sodium, potassium, calcium, BUN, creatinine, total protein, albumin, AST, ALT, total bilirubin, glucose ? Survival status | — |
Countries
Korea, Republic of
Contacts
Public ContactSang Cheol Lee
Soon Chun Hyang University Hospital Cheonan
Outcome results
None listed