Dosimetry Based PRRT Versus Standard Dose PRRT With Lu-177-DOTATOC in NEN Patients (DOBATOC)
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|ClinicalTrials.gov Identifier: NCT04917484|
Recruitment Status : Recruiting
First Posted : June 8, 2021
Last Update Posted : June 8, 2021
In this study, we want to randomize patients with neuroendocrine neoplasms (NENs) who are eligible for peptide receptor radionuclide therapy (PRRT), to either standard PRRT consisting of 4 treatments with 7.4 GBq Lu-177-DOTATOC (standard arm) or 4 treatments with individualized doses of Lu-177-DOTATOC (dosimetry arm). In the dosimetry arm, the first dose depends on the patients' kidney function and thereafter the absorbed dose to the kidneys at the previous treatment. A max of 20GBq will be administered at the first treatment and 25GBq at treatment 2-4. We aim to reach an accumulated kidney dose of 24Gy.
After the first treatment all patients will go through three SPECT/CT scans 24 hours, 4 days, and 7 days, after treatment to calculate absorbed kidney dose. The patients in the standard dose treatment arm will have one SPECT/CT scan after each of the last three treatments; all performed 24 hours after treatment, used to approximate the kidney dose assuming the clearance of the Lu-177 DOTATOC is the same after all treatments. The patients in the dosimetry based treatment arm will go through three SPECT/CT scans after all four treatments for dosimetry calculation.
Bone marrow dosimetry is calculated after all treatments in the dosimetry based treatment arm and after the first treatment in the standard treatment arm. For bone marrow dosimetry, blood samples are drawn right before administration of Lu-177 DOTATOC (time 0) and 3 minutes, 45 minutes, 2 hours, 4 hours, 7-8 hours, 24 hours, 4 days, and 7 days after administration of Lu-177 DOTATOC.
Standard blood samples are routinely drawn every 2nd week after every treatment in all included patients and analysed regarding liver, kidney and bone marrow function. Kidney clearance is evaluated with Tc-DTPA clearance at baseline.
Blood and urinary samples will be collected at baseline and 3 months after the last treatment for kidney fibrosis analyses.
At baseline, blood and urine samples are collected for a biobank. All included patients fill in validated quality of life questionaires at all treatments.
To evaluate the effect of the treatment, all patients will be evaluated with standard CT scans prior to treatment and 3 and 9 months after the 4th treatment. Ga-68 DOTATOC PET will be performed at baseline and 6 and 12 months after the last treatment.
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Neoplasm||Drug: Lu-177-DOTA-Octreotide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, non blinded|
|Masking:||None (Open Label)|
|Official Title:||Dosimetry Based PRRT Versus Standard Dose PRRT With Lu-177-DOTATOC in NEN Patients- a Randomized Study; a Step Towards Tailored PRRT|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
Active Comparator: Standard
Patients in this arm receive our standard treatment. Four treatment with standard dose of 7.4 GBq Lu-177-DOTATOC
Lu-177-DOTATOC in standard doses or individualized doses.
Patients in this treatment arm receive individualized calcuted treatment depending on kidney function and kidney dose. The treatment activity can differ from one treatment to the next.
Lu-177-DOTATOC in standard doses or individualized doses.
- Progression free survival [ Time Frame: 12 months after LPLV ]Defined as time from randomization to documented disease progression or death by any cause, evaluated by CT, RECIST 1.1.
- Tumor dose [ Time Frame: Through out the study efter each patient has completed treatment, up to 48 weeks ]Difference in tumor dose between dosimetry based and standard PRRT treatment groups and between patients in the dosimetry based treatment group over time.
- Kidney toxicity [ Time Frame: At baseline and after 3, 6 and 12 months ]Measured by Tc-DTPA clearance
- Kidney toxicity [ Time Frame: At baseline and 3 months after the last treatment ]Measured by kidney fibrosis markers PRO-C6, PRO-C3, and C3M two groups
- Bone marrow function, hemoglobin [ Time Frame: Every second week in up to 64 weeks ]Measured by hemoglobin in the two groups
- Bone marrow function, white blood cells [ Time Frame: Every second week in up to 64 weeks ]Measured by white blood cells in the two groups
- Bone marrow function, platelets [ Time Frame: Every second week in up to 64 weeks ]Measured by platelets in the two groups
- Subjective side effects [ Time Frame: After every treatment, up to 48 weeks ]Evaluated by use of dedicated questionaire with score from 0-3
- Quality of life score 1 [ Time Frame: After every treatment, up to 48 weeks ]Evaluated by questionnaire EORTC QLQ-30 filled out at every treatment
- Quality of life score 2 [ Time Frame: After every treatment, up to 48 weeks ]Evaluated by questionnaire QLQ-GI.NET21. filled out at every treatment
- Overall survival [ Time Frame: 3 years after LPLV ]Registration of time for baseline to death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04917484
|Contact: Tine N Gregersen, MD, PhDemail@example.com|
|Aarhus University Hospital, department of Nuclear medicine and PET centre||Recruiting|
|Aarhus, Palle Juul-Jensens Boulevard, Denmark, 8200|
|Contact: Tine N Gregersen, MD, PhD 004522334161 firstname.lastname@example.org|
|Sub-Investigator: Anne K Arveschoug, MD|
|Sub-Investigator: Peter F Staanum, Physicist, Ph.D|
|Sub-Investigator: Peter Iversen, MD, PhD|
|Sub-Investigator: Gitte A Dam, MD, PhD|
|Sub-Investigator: Henning Gronbaek, Prof MD, PhD|
|Sub-Investigator: Gerda E Villadsen, MD, PhD|