Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.

Sponsor
Lund University Hospital
Study ID
NCT05387603
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 177Lu-DOTATOC — 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 — 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.

Study Details

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.

Key Dates

First listed
May 24, 2022
Start date
Nov 1, 2022
Status verified
Sep 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Median progression free survival (PFS) defined as time from randomization to radiological progression. [ Time Frame: Before start of treatment (within 4 weeks), then every 10 +/- 2 weeks weeks, at follow up (every 3-6 month (investigators choice) until progression. ]

Central Contacts

Find similar trials

Nationwide
Neuroendocrine tumors trialsOncology trials

Related Studies