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New treatment option for Digestive System Neuroendocrine Tumor G1
Official title Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors
ClinicalTrials.gov ID: NCT06016855
What this study is testing
What is Lutetium Lu 177 Dotatate?
Lutetium Lu 177 Dotatate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for digestive system neuroendocrine tumor g1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed and dated written informed consent
- Male or female \>= 18 years of age on the day of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Histologically confirmed well-differentiated gastrointestinal or pancreatic neuroendocrine tumor that is grade 1 or grade 2 (Ki-67 =\< 20%)
- Somatostatin receptor avidity of known or suspected neuroendocrine tumor (NET) lesion(s) assessed by a baseline copper-64 dotatate PET/CT scan...
You likely can't join if
- Patient has any tumor \> 3 cm deemed to be inoperable
- Patient has disease which is considered to be completely surgically resectable
- Patient has grade 3 neuroendocrine neoplasm (well-differentiated or poorly-differentiated tumor)
- Prior receipt of peptide receptor radionuclide therapy (PRRT)
- Patient possesses untreated or growing brain metastases (growth within 90 days prior to surgical debulking on day 0 of participation in this study)
- Unstable angina, congestive heart failure with New York Heart Association (NYHA) functional classification III or IV, or uncontrolled symptomatic...
See the full eligibility criteria
- Signed and dated written informed consent
- Male or female \>= 18 years of age on the day of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Histologically confirmed well-differentiated gastrointestinal or pancreatic neuroendocrine tumor that is grade 1 or grade 2 (Ki-67 =\< 20%)
- Somatostatin receptor avidity of known or suspected neuroendocrine tumor (NET) lesion(s) assessed by a baseline copper-64 dotatate PET/CT scan performed within 6 months (180 days) prior to surgical debulking on study...
- Patient must have hepatic metastasis or hepatic metastases. Provided required hepatic metastatic disease is present, patient can also have any other site or sites of metastatic disease
- White blood cell count (WBC) \>= 2000/uL (resulted =\< 90 days prior to surgical debulking on day 0 of participation in this study)
- Platelets \>= 75,000/uL (resulted =\< 90 days prior to surgical debulking on day 0 of participation in this study)
- Hemoglobin \>= 8.0 g/dL (resulted =\< 90 days prior to surgical debulking on day 0 of participation in this study)
- Creatinine clearance (CrCl) \>= 30 mL/minute (as calculated by the Cockcroft-Gault Formula with estimated creatinine clearance rate [eCCR] \>= 30 mL/min required for eligibility inclusion; or calculated/measured by an...
- Total bilirubin =\< 3.0 times institutional upper limit of normal (ULN) (resulted =\< 90 days prior to surgical debulking on day 0 of participation in this study)
- Serum albumin \>= 3.0 g/dL unless the prothrombin time is within normal range (resulted =\< 90 days prior to surgical debulking on day 0 of participation in this study)
- Women must not be breastfeeding and further agree to not breastfeed during treatment with lutetium Lu 177 dotatate; and for at least 2.5 months after patient's final dose of lutetium Lu 177 dotatate
- A woman of childbearing potential (WOCBP) - must have a negative serum or urine pregnancy test resulted within 28 days prior to initiation of first dose of lutetium Lu 177 dotatate on cycle 1, day 1; and must agree to...
- A man able to father children who is sexually active with a WOCBP must agree to follow instructions for using acceptable contraception, from the time of signing consent, and until 4 months after his final dose of...
- Patient has any tumor \> 3 cm deemed to be inoperable
- Patient has disease which is considered to be completely surgically resectable
- Patient has grade 3 neuroendocrine neoplasm (well-differentiated or poorly-differentiated tumor)
- Prior receipt of peptide receptor radionuclide therapy (PRRT)
- Patient possesses untreated or growing brain metastases (growth within 90 days prior to surgical debulking on day 0 of participation in this study)
- Unstable angina, congestive heart failure with New York Heart Association (NYHA) functional classification III or IV, or uncontrolled symptomatic cardiac arrythmia
- Any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which in the judgment of the patient's study physician may reasonably be expected to interfere with patient's...
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.