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FIRST LINE CHEMOTHERAPY FOR METASTATIC GASTRO ENTERO PANCREATIC NEUROENDOCRINE CARCINOMA
EU CTIS ID: 2024-515300-39-00
What this study is testing
To compare the progression-free survival (PFS) with mFOLFIRINOX regimen versus platinum - etoposide regimen according to the investigator using RECIST v1.1 criteria.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Grade 3 neuroendocrine carcinoma (Ki67>20%) or high grade MiNEN with a grade 3 poorly differentiated neuroendocrine carcinoma
- Total bilirubin ≤ 1.5N, AST ≤ 2.5N, ALT≤ 2.5N or AST and ALT ≤ 5N in case of liver metastasis.
- Age ≥ 18 years
- Signed and dated informed consent, and willing and able to comply with protocol requirements.
- Women of childbearing potential, as well as men (who have sexual relations with women of childbearing potential) must agree to use an effective method of contraception throughout this study and during the 15 months following administration of the last dose of the study medicinal product
- Patient who is a beneficiary of the Social security system
You likely can't join if
- Grade 3 well differentiated neuroendocrine tumor according to WHO 2017 classification
- Treatment with St John's Wort (Hypericum perforatum)
- Pregnant women or breastfeeding mother
- Known or historical active infection with HIV, or known active infection untreated with hepatitis B or hepatitis C
- History of prior malignancy in the three yars before randomization, except for cured non-melanoma skin cancer and cured in situ cervical carcinoma.
- Active or suspected acute or chronic uncontrolled disease that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
See the full eligibility criteria
Who can join
- Grade 3 neuroendocrine carcinoma (Ki67>20%) or high grade MiNEN with a grade 3 poorly differentiated neuroendocrine carcinoma
- Total bilirubin ≤ 1.5N, AST ≤ 2.5N, ALT≤ 2.5N or AST and ALT ≤ 5N in case of liver metastasis.
- Age ≥ 18 years
- Signed and dated informed consent, and willing and able to comply with protocol requirements.
- Women of childbearing potential, as well as men (who have sexual relations with women of childbearing potential) must agree to use an effective method of contraception throughout this study and during the 15 months following administration of the last dose of the study medicinal product
- Patient who is a beneficiary of the Social security system
- Primary gastro-entero-pancreatic or unknown primary
- Small cell or large cell or non-small cell or non- typeable neuroendocrine carcinoma
- Metastatic disease
- ECOG performance status ≤ 1
- First line treatment for metastatic disease. No prior chemotherapy or systemic therapy for management of metastatic disease or primary tumor
- At least one measurable lesion as assessed by CT-scan or MRI according to RECIST 1.1 guidelines
- Available tumor block
- ANC ≥ 1.5x109/l, platelet ≥ 100x109/l and haemoglobin > 8 g/dl
What rules you out
- Grade 3 well differentiated neuroendocrine tumor according to WHO 2017 classification
- Treatment with St John's Wort (Hypericum perforatum)
- Pregnant women or breastfeeding mother
- Known or historical active infection with HIV, or known active infection untreated with hepatitis B or hepatitis C
- History of prior malignancy in the three yars before randomization, except for cured non-melanoma skin cancer and cured in situ cervical carcinoma.
- Active or suspected acute or chronic uncontrolled disease that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- vaccinations (live vaccine) within 30 days prior to start of study drugs
- Patient under guardianship and/or deprived of his/her freedom
- QTc interval > 450 msec for male and > 470 msec for female at EKC.
- K+ < LLN, Mg²+ < LLN, Ca²+ < LLN
- History or know hypersensitivity to any of the study chemotherapy agents, or their excipients.
- Severe renal impairment (creatinine clearance less than 30 mL/min, Cockroft and Gault)
- Patient already participating in another clinical trial who is currently being treated or whose treatment was completed less than four weeks prior to inclusion.
- ECOG performance status > 1
- Partial or complete Dihydropyrimidine Dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
- Known Gilbert's syndrome
- Pre-existing permanent neuropathy (NCI CTC V4.0 grade ≥2)
- Previously treated by chemotherapy or targeted therapy
- Symptomatic brain metastases patient with asymptomatic brain metastases or under stable corticosteroid doses for at least 2 weeks before randomization can be included.
- Combination with sorivudine and others analogues of dihydropyrimidine dehydrogenase)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.