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NCT Number: NCT04917484

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

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.

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Key information

Conditions

Neuroendocrine Neoplasm Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aarhus University Hospital, department of Nuclear medicine and PET centre

Aarhus, Palle Juul-Jensens Boulevard, 8200, Denmark

Location status: Recruiting

Location contact

Anne K Arveschoug, MD

SUB_INVESTIGATOR

Gerda E Villadsen, MD, PhD

SUB_INVESTIGATOR

Gitte A Dam, MD, PhD

SUB_INVESTIGATOR

Henning Gronbaek, Prof MD, PhD

SUB_INVESTIGATOR

Peter F Staanum, Physicist, Ph.D

SUB_INVESTIGATOR

Peter Iversen, MD, PhD

SUB_INVESTIGATOR

Tine N Gregersen, MD, PhD

CONTACT

[email protected]

004522334161

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

Lu-177-DOTA-Octreotide

Drug

Lu-177-DOTATOC in standard doses or individualized doses.

Primary outcomes

  1. 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.

Secondary outcomes

  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.

Other outcomes

  1. Kidney toxicity

    Time frame: At baseline and after 3, 6 and 12 months

    Measured by Tc-DTPA clearance

  2. 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

  3. Bone marrow function, hemoglobin

    Time frame: Every second week in up to 64 weeks

    Measured by hemoglobin in the two groups

  4. 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

  5. Bone marrow function, platelets

    Time frame: Every second week in up to 64 weeks

    Measured by platelets in the two groups

  6. Subjective side effects

    Time frame: After every treatment, up to 48 weeks

    Evaluated by use of dedicated questionaire with score from 0-3

  7. 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

  8. 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

  9. Overall survival

    Time frame: 3 years after LPLV

    Registration of time for baseline to death

Study contacts

Contact information is provided by the study sponsor or research team.

Tine N Gregersen, MD, PhD

CONTACT

[email protected]

+4522334161

Sponsors and collaborators

Lead sponsor

Tine Gregersen, MD

Other

Registry information

Official study title

Dosimetry Based PRRT Versus Standard Dose PRRT With Lu-177-DOTATOC in NEN Patients- a Randomized Study; a Step Towards Tailored PRRT

Acronym: DOBATOC

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jun 8, 2021
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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