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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002218-15 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. . |
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| 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. |
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| Standard 177Lu-DOTATOC | Active Comparator | Standard treatment of 177Lu-DOTATOC with treatment for 4 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of treatment-related adverse reactions | Treatment-related adverse reactions graded according to CTCAE v.5.0. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pernilla Asp, MD, Senior consultant | Contact | +46 46 17 75 20 | pernilla.p.asp@skane.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital, Dept. of Oncology | Recruiting | Gothenburg | Sweden |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C504257 | 177Lu-octreotide, DOTA(0)-Tyr(3)- |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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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).
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| 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. |
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Median OS defined as time from randomization to death of any cause. |
| 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). | 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. | 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. | 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. | 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. | 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). | 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). | Through study completion, an average of 18 months, assessed every 10 +/- 2 weeks by questionnaires. |
| Skåne University Hospital, Dept. of Oncology | Recruiting | Lund | SE-226 52 | Sweden |
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| Karolinska University Hospital, Dept. of Oncology | Recruiting | Stockholm | SE-171 76 | Sweden |
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| Accademical Hospital, Uppsala, Dept. of Oncology | Recruiting | Uppsala | SE-752 37 | Sweden |
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| D009380 | Neoplasms, Nerve Tissue |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |