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Evaluate the efficacy of 12-month neoadjuvant chemotherapy in terms of disease-free survival in patients with localized digestive neuroendocrine carcinomas
EU CTIS ID: 2024-515603-19-00
What this study is testing
Phase II Demonstrate a benefit in terms of relapse-free survival (RFS) at 12 months after the start of administration of neoadjuvant therapy in patients with resectable localized digestive CNE.
- 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
- Histologically proven digestive CNE on biopsy, (the WHO 2017 classification: poorly differentiated and Ki 67 > 20%),
- Patients with localized CNE, without metastasis (computed tomography [CT], thoraco-abdominopelvic CT scan [TAP] according to RECIST 1.1; examinations performed no later than 21 days before starting the study treatment, possible locoregional lymph node involvement defined according to the TNM classification),
- Positron emission tomography (PET) and CT for lymph node status and elimination of secondary visceral and/or bone disorders,
- Resectable tumor, according to the consensus decision made during local multidisciplinary surgical consultation meeting,
- Age ≥ 18 years
- For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study treatment. Men and women are required to use a reliable and adequate birth control during the study (if applicable) during the period of treatment and during 6 months from the last treatment administration
You likely can't join if
- Well-differentiated NEC, whatever the grade
- Metastatic disease
- Cancer of unknown primary
- Organ failure that does not allow chemotherapy treatment
- History of invasive malignacy disease within 5 years prior to the study except for cutaneous basal cell carcinoma and uterine cancer in situ
- Tumor with a mixed component (component accounts for ≥ 30%),
See the full eligibility criteria
- Histologically proven digestive CNE on biopsy, (the WHO 2017 classification: poorly differentiated and Ki 67 > 20%),
- Patients with localized CNE, without metastasis (computed tomography [CT], thoraco-abdominopelvic CT scan [TAP] according to RECIST 1.1; examinations performed no later than 21 days before starting the study treatment, possible locoregional lymph node involvement defined according to the TNM classification),
- Positron emission tomography (PET) and CT for lymph node status and elimination of secondary visceral and/or bone disorders,
- Resectable tumor, according to the consensus decision made during local multidisciplinary surgical consultation meeting,
- Age ≥ 18 years
- For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study treatment. Men and women are required to use a reliable and adequate birth control during the study (if applicable) during the period of treatment and during 6 months from the last treatment administration
- Well-differentiated NEC, whatever the grade
- Metastatic disease
- Cancer of unknown primary
- Organ failure that does not allow chemotherapy treatment
- History of invasive malignacy disease within 5 years prior to the study except for cutaneous basal cell carcinoma and uterine cancer in situ
- Tumor with a mixed component (component accounts for ≥ 30%),
- Other than platinum-etoposide chemotherapy administrated,
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, 18-64 years, 65+ 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.