Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.

NCT ID: NCT05387603

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2026-10-01

Brief 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.

Conditions

Neuroendocrine Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

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Group Type: EXPERIMENTAL

177Lu-DOTATOC

Intervention Type: DRUG

The investigational medicinal product (IMP) is 177Lu-DOTATOC which is registered as an orphan drug by the EMA ( European Medicines Agency) for the treatment of GEP-NEN (gastro-entero-pancreatic neuroendocrine tumor).

The IMP will be administered to participants both in the control arm and the experimental arms, but with different intervals, but the same activity; 7.5 Gbq per dosing.

Capecitabine

Intervention Type: DRUG

Will be given orally with a dose of 825/m2 twice daily, starting on day 1 of each of the 4 first treatment cycles, cycle length 3 weeks.

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.

Group Type: EXPERIMENTAL

177Lu-DOTATOC

Intervention Type: DRUG

The investigational medicinal product (IMP) is 177Lu-DOTATOC which is registered as an orphan drug by the EMA ( European Medicines Agency) for the treatment of GEP-NEN (gastro-entero-pancreatic neuroendocrine tumor).

The IMP will be administered to participants both in the control arm and the experimental arms, but with different intervals, but the same activity; 7.5 Gbq per dosing.

Standard 177Lu-DOTATOC

Standard treatment of 177Lu-DOTATOC with treatment for 4 cycles.

Group Type: ACTIVE_COMPARATOR

177Lu-DOTATOC

Intervention Type: DRUG

The investigational medicinal product (IMP) is 177Lu-DOTATOC which is registered as an orphan drug by the EMA ( European Medicines Agency) for the treatment of GEP-NEN (gastro-entero-pancreatic neuroendocrine tumor).

The IMP will be administered to participants both in the control arm and the experimental arms, but with different intervals, but the same activity; 7.5 Gbq per dosing.

Interventions

177Lu-DOTATOC

The investigational medicinal product (IMP) is 177Lu-DOTATOC which is registered as an orphan drug by the EMA ( European Medicines Agency) for the treatment of GEP-NEN (gastro-entero-pancreatic neuroendocrine tumor).

The IMP will be administered to participants both in the control arm and the experimental arms, but with different intervals, but the same activity; 7.5 Gbq per dosing.

Intervention Type: DRUG

Capecitabine

Will be given orally with a dose of 825/m2 twice daily, starting on day 1 of each of the 4 first treatment cycles, cycle length 3 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Pregnancy or lactation
• Previous treatment with PRRT
• Concomitant systemic anti-tumor therapy other than somatostatin analogue (SSA)
• Contraindications for treatment with capecitabine according to the approved label.
• Discordance between CT/MRI/18F-FDG-PET and 68Ga-DOTA-PET, with evidence of tumor lesions without uptake on 68Ga-DOTATOC.
• Any other serious, uncontrolled medical or psychiatric condition that, in the opinion of the investigator, precludes the patient from participation in the trial
• Unwillingness, or inability, to participate in any part of the trial procedures or treatments.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sahlgrenska University Hospital, Dept. of Oncology

Gothenburg, , Sweden

Site Status: RECRUITING

Skåne University Hospital, Dept. of Oncology

Lund, , Sweden

Site Status: RECRUITING

Karolinska University Hospital, Dept. of Oncology

Stockholm, , Sweden

Site Status: RECRUITING

Accademical Hospital, Uppsala, Dept. of Oncology

Uppsala, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Pernilla Asp, MD, Senior consultant

Role: CONTACT

pernilla.p.asp@skane.se

+46 46 17 75 20

Facility Contacts

Anders Hallqvist, MD; Senoor consultant

Role: primary

anders.hallqvist@vgregion.se

+46 31 -342 10 00

Pernilla Asp, MD, Senior Consultant

Role: primary

pernilla.p.asp@skane.se

+46 46 17 75 20

Renske Altena, MD, Senior Consultant

Role: primary

+46 8 517 700 00

Katarzyna Fröss-Baron, MD, Senior Consultant

Role: primary

katarzyna.fross_baron@medsci.uu.se

+46 18 611 40 68

Other Identifiers

2021-002218-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

START-01

Identifier Type: -

Identifier Source: org_study_id