Neuroendocrine TumorsPhase 3START-NETNCT05387603
Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.
A Phase 3 study testing 177Lu-DOTATOC and Capecitabine in people with Neuroendocrine Tumors, run by Lund University Hospital at 4 sites in Sweden.
Trial summary
There are several ways of personalizing PRRT (peptide receptor radionuclide treatment) in NEN (neuroendocrine neoplasia). Nevertheless, the current treatment regimen is not personalized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 177Lu-DOTATOC and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesSweden
- Study dates
- 1 Nov 2022to 1 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Recruiting
Sahlgrenska University Hospital, Dept. of Oncology
Gothenburg
Anders Hallqvist, MD; Senoor consultant, +46 31 -342 10 00, anders.hallqvist@vgregion.se
Anders Hallqvist, MD, Senior Consultant
- Recruiting
Skåne University Hospital, Dept. of Oncology
Lund, SE-226 52
Pernilla Asp, MD, Senior Consultant, +46 46 17 75 20, pernilla.p.asp@skane.se
Pernilla Asp, MD, Senior consultant
- Recruiting
Karolinska University Hospital, Dept. of Oncology
Stockholm, SE-171 76
Renske Altena, MD, Senior Consultant, +46 8 517 700 00
Renske ltena, MD, Senior Consultant
- Recruiting
Accademical Hospital, Uppsala, Dept. of Oncology
Uppsala, SE-752 37
Katarzyna Fröss-Baron, MD, Senior Consultant, +46 18 611 40 68, katarzyna.fross_baron@medsci.uu.se
Katarzyna Fröss-Baron, MD, Senior Consultant
About this study
Official title: 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.
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
- Being tested
- 177Lu-DOTATOC, Capecitabine
- Keywords
- Neuroendocrine tumors, Radionuclide therapy, Personalized radionuclide therapy, 177Lu-DOTATOC, Capecitabine, Dosimetry-based radionuclide therapy, Somatostatin receptor, Lutetium, Beta- and gamma-emitting radionuclide, Translational research
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-DOTATOCDrug
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.
CapecitabineDrug
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 group | Role | What they receive |
|---|---|---|
| 177Lu-DOTATOC + Capecitabine | Experimental | 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.
. Receives: Drug: 177Lu-DOTATOC; Drug: Capecitabine |
| 177Lu-DOTATOC | Experimental | 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. Receives: Drug: 177Lu-DOTATOC |
| Standard 177Lu-DOTATOC | Active comparator | Standard treatment of 177Lu-DOTATOC with treatment for 4 cycles. Receives: Drug: 177Lu-DOTATOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median progression free survival (PFS) defined as time from randomization to radiological progression.
Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 16-22 weeks.
Measured: Before start of treatment (within 4 weeks), then every 10 +/- 2 weeks weeks, at follow up (every 3-6 month (investigators choice) until progression.
Median progression free survival (PFS) defined as time from randomization to radiological progression.
Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 10 +/- 2 weeks.
Measured: Before start of treatment (within 4 weeks), then every 10 +/- week at follow up (every 3-6 month (investigators choice) until death.
Median progression free survival (PFS) defined as time from randomization to radiological progression,
Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 16-22 weeks.
Measured: Before start of treatment (within 4 weeks), then every 10 +/- 2 weeks, at follow up (every 3-6 month (investigators choice) or patients withdrawal of concent.. No end can be given.
Secondary outcomes (9)
Rate of treatment-related adverse reactions
Treatment-related adverse reactions graded according to CTCAE v.5.0.
Measured: At every treatment cycle, cycle length is 10 +/-2 weeks, at treatment follow up every 3-6 month (investigators choice) until progression. No time point can be given.
Median overall survival (OS).
Median OS defined as time from randomization to death of any cause.
Measured: From date of randomization until the date of death. Timepoint unknown, as date of death can´t be predicted.
Progression free survival.
Median progression free survival (PFS).
Measured: From time of randomization until the date of first documented progression. Is evaluated within 4 weeks before randomization, after each treatment, every 10 +/2 weeks. Timepoint unknown, as date of progression can´t be predicted.
Percent change in sum of longest diameters (SLD) of tumor lesions.
Percent change in SLD from baseline (within 4 weeks before treatment) to time of best response.
Measured: At each radiological investigation with CT or MRI of thorax and abdomen. Is done every 10 +/- 2 weeks. In the follow up period, evaluations are done every 3-6 months until death.
Quality of Life as judged by the patient.
All patients complete the Eastern Cooperative Oncology Group (EORTC) QoL (quality of life)-questionnaires GI- neuroendocrine tumors (NET)21.
Measured: Patients complete the QoL forms before start of treatment, at cycle 2 (cycle length 10+/-2 weeks), at each treatment cycle (4-approximately 7), until progression.
Cumulative median absorbed dose (AD)
AD to target tumor lesions in subjects with complete remission (CR), partial remission (PR), stable disease (SD) and progressive disease (PD) as best response, according to RECIST evaluations.
Measured: After each dosimetry measurements after each treatment cycle (cycle length 10 +/2 weeks), up to 18 +/-2 months.
Correlation between cumulative median absorbed dose and time to progression.
Correlation between cumulative median absorbed dose to target tumor lesions and time to progression, defined as time from randomization to radiological progression.
Measured: Every 10 +/- 2 weeks up to 18 +/- 2 months.
Cumulative median absorbed dose (AD) and biological effective dose to kidneys.
Cumulative median AD and biological effective dose (BED) to kidneys vs rate of grade 3-4 renal toxicity (estimated and measured GFR ( glomerular filtration rate).
Measured: Is evaluated with dosimetry after each treatment, 10 +/- 2 weeks, up to 18 +/- 2 months.
Differences in resource utilization and treatment cost.
Differences in resource utilization and treatment cost between the two treatment arms, in relation to the progressive free survival (PFS) and overall survival (OS).
Measured: Through study completion, an average of 18 months, assessed every 10 +/- 2 weeks by questionnaires.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Nov 2022
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, open-label, controlled trial in which patients are assigned to either non-personalized treatment with 4 cycles of 7.5 gigabequerel (GBq) 177Lu-DOTATOC (TOC), or personalized treatment based on dual imaging. In the personalized arm patients are treated according to the results of the dual imaging at screening: A. Patients with 68Ga-1,4,7,10-tetra-azacyclododecane-N.n,N,N-tetraacetic acid (DOTA)-positron emission tomography (PET)-positive but 18F-2-fluoro-2-deoxy-D-glucosefluorodeoxyglucose (FDG)-PET-negative NET will receive dosimetry-based PRRT only (dTOC) B. Patients with 68Ga-DOTA- and 18F-FDG-PET-positive NET will receive a combination of capecitabine and dosimetry-based PRRT (CAP-dTOC).
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387603
- Sponsor's protocol ID
- START-01
- Other IDs
- 2021-002218-15
- Acronym
- START-NET
- Status last verified
- Sep 2025
- First submitted
- 21 Apr 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05387603
- Acronym / sponsor ID
- START-NET / START-01
- Conditions
- Neuroendocrine Tumors
- Keywords
- Neuroendocrine tumors, Radionuclide therapy, Personalized radionuclide therapy, 177Lu-DOTATOC, Capecitabine, Dosimetry-based radionuclide therapy, Somatostatin receptor, Lutetium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized, open-label, controlled trial in which patients are assigned to either non-personalized treatment with 4 cycles of 7.5 gigabequerel (GBq) 177Lu-DOTATOC (TOC), or personalized treatment based on dual imaging. In the personalized arm patients are treated according to the results of the dual imaging at screening: A. Patients with 68Ga-1,4,7,10-tetra-azacyclododecane-N.n,N,N-tetraacetic acid (DOTA)-positron emission tomography (PET)-positive but 18F-2-fluoro-2-deoxy-D-glucosefluorodeoxyglucose (FDG)-PET-negative NET will receive dosimetry-based PRRT only (dTOC) B. Patients with 68Ga-DOTA- and 18F-FDG-PET-positive NET will receive a combination of capecitabine and dosimetry-based PRRT (CAP-dTOC).
| Arm | Type | Receives |
|---|---|---|
| 177Lu-DOTATOC + Capecitabine | Experimental | Drug: 177Lu-DOTATOC, Drug: CapecitabinePatients 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. . |
| 177Lu-DOTATOC | Experimental | Drug: 177Lu-DOTATOCIntravenous 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. |
| Standard 177Lu-DOTATOC | Active comparator | Drug: 177Lu-DOTATOCStandard treatment of 177Lu-DOTATOC with treatment for 4 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lu-DOTATOCThe 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. | Drug | 177Lu-DOTATOC, 177Lu-DOTATOC + Capecitabine, Standard 177Lu-DOTATOC |
| CapecitabineWill 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. | Drug | 177Lu-DOTATOC + Capecitabine |
Primary outcome
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.
Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 16-22 weeks.
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 +/- week at follow up (every 3-6 month (investigators choice) until death.
Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 10 +/- 2 weeks.
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, at follow up (every 3-6 month (investigators choice) or patients withdrawal of concent.. No end can be given.
Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 16-22 weeks.
9 secondary outcomes
Rate of treatment-related adverse reactions
Time frame: At every treatment cycle, cycle length is 10 +/-2 weeks, at treatment follow up every 3-6 month (investigators choice) until progression. No time point can be given.
Median overall survival (OS).
Time frame: From date of randomization until the date of death. Timepoint unknown, as date of death can´t be predicted.
Progression free survival.
Time frame: From time of randomization until the date of first documented progression. Is evaluated within 4 weeks before randomization, after each treatment, every 10 +/2 weeks. Timepoint unknown, as date of progression can´t be predicted.
Percent change in sum of longest diameters (SLD) of tumor lesions.
Time frame: At each radiological investigation with CT or MRI of thorax and abdomen. Is done every 10 +/- 2 weeks. In the follow up period, evaluations are done every 3-6 months until death.
Quality of Life as judged by the patient.
Time frame: Patients complete the QoL forms before start of treatment, at cycle 2 (cycle length 10+/-2 weeks), at each treatment cycle (4-approximately 7), until progression.
Cumulative median absorbed dose (AD)
Time frame: After each dosimetry measurements after each treatment cycle (cycle length 10 +/2 weeks), up to 18 +/-2 months.
Correlation between cumulative median absorbed dose and time to progression.
Time frame: Every 10 +/- 2 weeks up to 18 +/- 2 months.
Cumulative median absorbed dose (AD) and biological effective dose to kidneys.
Time frame: Is evaluated with dosimetry after each treatment, 10 +/- 2 weeks, up to 18 +/- 2 months.
Differences in resource utilization and treatment cost.
Time frame: Through study completion, an average of 18 months, assessed every 10 +/- 2 weeks by questionnaires.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 177Lu-DOTATOC and Capecitabine in people with Neuroendocrine Tumors, run by Lund University Hospital at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pernilla Asp, MD, Senior consultant (+46 46 17 75 20, pernilla.p.asp@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.