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Compares treatment options for Neuroendocrine Neoplasia's (NENs)
Official title PRRT Versus PRRT Plus Chemotherapy in GEP NET (PReCedeNT Trial)
ClinicalTrials.gov ID: NCT07185672
What this study is testing
What is Capecitabine plus temozolamide?
Capecitabine plus temozolamide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for neuroendocrine neoplasia's (nens).
Also referred to as CAPE-TEM.
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
- Neuroendocrine tumours (NETs), better defined as neoplasms (NENs), are a heterogeneous group of neoplasms that range from well-differentiated tumours to more aggressive carcinomas. Peptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE is the established standard of care for patients with well-differentiated metastatic or locally advanced GEP-NETs.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Male or female, age greater than 18 years
- Histopathological diagnosis of GEP-NET, necessarily satisfying all the the criteria below
- Well differentiated G2 (Ki67 : ≥3-20%) OR G3 (ki67- greater than 20-55%), OR
- Well-differentiated G1 (\<3%) with disease progression in last 6 months
- Positive Ga-68-DOTANOC PET/CT, Krennings score \>/=3
You likely can't join if
- Serum creatinine level of more than 1.6 mg/dl or a creatinine clearance of less than 50 ml/min
- Hemoglobin level of less than 8.0 g per deciliter
- Red blood cell count noty less than 300,000/cubic millimeter White cell count of less than 2000 per cubic millimeter
- Platelet count of less than 75,000 per cubic millimetre
- Total bilirubin level of more than 3 times the upper limit of the normal range
- Serum albumin level \< 3.0 g/dl
See the full eligibility criteria
- Male or female, age greater than 18 years
- Histopathological diagnosis of GEP-NET, necessarily satisfying all the the criteria below
- Well differentiated G2 (Ki67 : ≥3-20%) OR G3 (ki67- greater than 20-55%), OR
- Well-differentiated G1 (\<3%) with disease progression in last 6 months
- Positive Ga-68-DOTANOC PET/CT, Krennings score \>/=3
- Positive FDG PET imaging, grade 3 or 4 uptake
- Locally advanced/inoperable disease or metastatic disease
- Karnofsky performance-status score of at least 60 or ECOG performance status \</= 2
- Life expectancy greater than 6 months
- Serum creatinine level of more than 1.6 mg/dl or a creatinine clearance of less than 50 ml/min
- Hemoglobin level of less than 8.0 g per deciliter
- Red blood cell count noty less than 300,000/cubic millimeter White cell count of less than 2000 per cubic millimeter
- Platelet count of less than 75,000 per cubic millimetre
- Total bilirubin level of more than 3 times the upper limit of the normal range
- Serum albumin level \< 3.0 g/dl
- Treatment with more than 30 mg of octreotide LAR within 4 weeks before randomisation.
- Peptide receptor radionuclide therapy at any time before randomisation
- Pregnancy and Lactation
- Patients with concurrent malignancies
The study team makes the final eligibility decision.
Where it's taking place
- Mumbai, Maharashtra, India
- Navi Mumbai, Maharashtra, India
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 Mumbai, Maharashtra, India; Navi Mumbai, Maharashtra, India. 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.