Dosimetry Based PRRT Versus Standard Dose PRRT With Lu-177-DOTATOC in NEN Patients

Launched by TINE GREGERSEN, MD · Jun 7, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called peptide receptor radionuclide therapy (PRRT) for patients with neuroendocrine neoplasms (NENs). Researchers want to compare two approaches: one using a standard dose of the treatment and the other using a personalized dose based on how well a patient’s kidneys are functioning. Both groups will receive a total of four treatments, but the personalized approach will adjust the dose depending on the patient’s kidney response after each treatment. The goal is to better protect the kidneys while treating the cancer.

To participate in this study, patients need to be at least 18 years old and have a confirmed diagnosis of NEN that has not responded to standard treatments. Key criteria include having good kidney and bone marrow function and a life expectancy of more than six months. Throughout the trial, participants will undergo various scans and blood tests to monitor their health, and they will be asked to complete quality of life questionnaires. This information will help researchers understand how well the treatments are working and if the personalized dosing is beneficial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients 18 years of age or more
• • 2. NEN confirmed by histology
• • 3. Clinical, PET/CT or CT proven progression despite standard treatment with somatostatin analogues, targeted therapy (Everolimus, sunitinib), chemotherapy (STZ/5-FU, temozolomide/capecitabine) OR intolerable side effects caused by these standard treatment OR unmanageable carcinoid symptoms
• • 4. WHO/ ECOG Performance Status of 0-2
• • 5. Life expectancy more than 6 months
• • 6. Uptake higher than liver in primary tumor or metastases on Ga-DOTATOC PET/CT (Krenning 3 or 4), if the scan is more than 3 months old at inclusion time, a new scan should be done.
• * 7. Adequate organ function as defined by:
• • Adequate kidney function: Patient glomerular filtration rate \>30 ml/min measured by Tc-DTPA clearance
• * Adequate bone marrow function:
• • WBC ≥ 2.0 x 109/L
• • Platelets ≥ 100 x 109/L
• • Hb ≥ 6 mmol/l (≥9.67 g/dL)
• • 8. Willingness and ability to comply with scheduled visits for SPECT/CT scans, treatment plans, laboratory tests and other study procedures.
• • 9. Written informed consent obtained prior to any screening procedures
• Exclusion Criteria:
• • 1. Tumor amenable to surgery and/or radiofrequency ablation
• • 2. Patients who are unable to stay isolated for 24 hours
• • 3. Previous PRRT
• * 4. Female patients who are pregnant or lactating. Women who are of childbearing potential (defined as all women physiologically capable of becoming pregnant) have to practice an effective method of contraception/birth control. Fertile female patients have to take a urinary pregnancy test, to ensure that they are not pregnant, before they can enter the study. After entering the study, they have to use effective contraception during the study period and 6 months after. Effective contraception methods include:
• • Use of oral, injected or implanted hormonal methods of contraception or
• • Placement of an intrauterine device (IUD) or intrauterine system (IUS)
• • Total abstinence or patient sterilization (male or female)
• • 5. Male patients are not allowed to conceive pregnancy for 6 months after last treatment cycle
• • 6. Known to be hypersensitive to any component of the Lu-177-DOTATOC
• • 7. Patients with meningioma