Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors. An Open-label, Multicenter, Randomized Phase III Trial Comparing Safety and Efficacy of Personalized Versus Non-personalized Radionuclide Therapy With 177Lu (Lutetium)-DOTATOC.

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

There are several ways of personalizing PRRT (peptide receptor radionuclide treatment) in NEN (neuroendocrine neoplasia). Nevertheless, the current treatment regimen is not personalized. This trial aims to compare personalized PRRT to non-personalized PRRT in terms of safety, efficacy and resource demands in order to optimize treatment outcomes in an evidence-based manner in future.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Written informed consent

• Eastern Cooperative Oncology Group (ECOG) 0-1

• Presence of histologically confirmed, advanced, well-differentiated, inoperable neuroendocrine tumors (NET) of any primary tumor origin and any grade, except for pheochromocytoma and paraganglioma.

• Somatostatine receptor (SSTR)-expression in tumor lesions \> basal liver uptake on 68Ga-DOTA-PET

• Radiologically progressive disease within the last 1-24 months according to common clinical criteria and confirmed by the institutional multidisciplinary conference for the treatment of NETs. The CT/MRI that shows tumor progression compared to screening/baseline must have been performed 1-24 months earlier.

• All previous anti-tumor treatment except SSA must be terminated at least 4 weeks before start of treatment within the trial.

• Measurable disease according to RECIST v 1.1

• Given the available, approved anti-tumor treatments and the specific characteristics of the patient and the tumor, the investigator judges peptide receptor radionuclide therapy (PRRT) to be the treatment of choice

• GFR \> 50 ml/min/1.73 m2 as determined by iohexol- or 51Cr-EDTA clearance, calculated according to a combination of LMR18 and CAPA formulas, or equally accurate method

• Hemoglobin \> 90 g/L, platelets \>100 x109/L, leukocytes \> 3.0x109/L, neutrophils \> 1.5 x109/L, aspartate transaminase (ASAT)/alanine aminotransferase (ALAT) \< 3 x ULN, bilirubin \< 2 x upper limit of normal (ULN), albumin \> 25 g/L

• For women of child-bearing potential, highly effective contraception should be used from the time of inclusion up to at least six months after the end of treatment (EOT) visit.

Locations
Other Locations
Sweden
Sahlgrenska University Hospital, Dept. of Oncology
RECRUITING
Gothenburg
Skåne University Hospital, Dept. of Oncology
RECRUITING
Lund
Karolinska University Hospital, Dept. of Oncology
RECRUITING
Stockholm
Accademical Hospital, Uppsala, Dept. of Oncology
RECRUITING
Uppsala
Contact Information
Primary
Pernilla Asp, MD, Senior consultant
pernilla.p.asp@skane.se
+46 46 17 75 20
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 300
Treatments
Experimental: 177Lu-DOTATOC + Capecitabine
Patients with 68Ga-DOTA- and 18F-FDG-PET-positive NET will receive a combination of intravenous 7.5 GBG (gigabequerel) 177Lu-DOTATOC for about 7 cycles in combination with capecitabine (4 cycles, cycle length 3 weeks, with one week without capecitabine, dosing 825 mg twice daily) and PRRT to a cumulative renal AD (absorbed dose) limit of 30 Gy and dosimetry-based PRRT.~.
Experimental: 177Lu-DOTATOC
Intravenous infusion for about 7 treatment cycles with 7.5 GBq 177Lu-DOTATOC with an interval of 10 ± 2 weeks and PRRT to a cumulative renal AD limit of 30 Gy and dosimetry-based PRRT.
Active_comparator: Standard 177Lu-DOTATOC
Standard treatment of 177Lu-DOTATOC with treatment for 4 cycles.
Related Therapeutic Areas
Sponsors
Leads: Lund University Hospital

This content was sourced from clinicaltrials.gov

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