START-NET: A randomized clinical trial to compare personalized vs non-personalized radionuclide therapy with 177Lu-DOTATOC
- Conditions
- Patients with SSTR+, advanced, progressive NET Grade 1-3 of any origin for whom Peptide-receptor radionuclide therapy, PRRT, is considered the mostappropriate treatment option in relation to other approved or available investigational agents for the specific tumor subtype.MedDRA version: 21.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-002218-15-SE
- Lead Sponsor
- Region Skåne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 300
1. The subject has given written informed consent to participate in the study.
2. Age =18 years
3. ECOG performance status 0-1
4. Life expectancy > 3 months.
5. Presence of histologically confirmed, advanced, well-differentiated, inoperable NETof any primary tumor origin (except pheochromocytoma and paraganglioma) and any grade, with a maximum Ki67 of 50%
6. SSTR-expression (mean SUV) in tumor lesions = 2x mean SUV in normal liver on 68Ga-DOTA-PET performed = 3 months prior to randomization. Due to partial volume effects, tumor lesions smaller than 1 cm on CT or MRI should not be used to evaluate this eligibility criterium.
7. 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.
8. All previous anti-tumor treatment except SSA must be terminated at least 4 weeks before start of treatment within the trial
9. Measurable disease according to RECIST v 1.1
10. Given the available, approved anti-tumor treatments and the specific characteristics of the patient and the tumor, the investigator judges PRRT to be the treatment of choice
11. 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
12. Adequate hematological parameters as defined by: Hemoglobin > 90 g/L, platelets >100 x109/L, leukocytes > 3.0x109/L, neutrophils > 1.5 x109/L
13. Adequate hepatic function as defined by ASAT/ALAT < 3 x ULN, bilirubin < 2 x ULN, albumin > 25 g/L.
14. For women of child-bearing potential, highly effective contraception should be usedfrom the time of inclusion up to at least six months after the EOT visit. For details see appendix 5.
15. For male subjects living with a woman of child-bearing potential, adequate contraception should be used from the time of inclusion up to at least six months after the EOT visit. Adequate male contraception methods are vasectomy, surgical or pharmacological castration, or the use of condom during heterosexual intercourse.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220
1. Pregnancy or lactation
2. Previous treatment with PRRT for NET
3. Concomitant systemic anti-tumor therapy other than SSA
4. Participation or recent participation in a clinical study with an investigational product within 30 days of randomization.
5. Known hypersensitivity to edotreotide, octreotide, capecitabine or any of the excipients included in the preparations.
6. Contraindications for treatment with capecitabine:
a. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusion.
b. New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
c. Previous serious or unexpected reactions to fluoropyrimidine treatment
d. Known complete deficiency of dihydropyrimidine dehydrogenase (DPD)
e. Recent or concomitant treatment with brivudine
7. Discordance between CT/MRI/18F-FDG-PET and 68Ga-DOTA-PET, with evidence of tumor lesions without uptake on 68Ga-DOTA-PET
8. Liver-directed therapy of metastases (i.e. radioembolization, chemoembolization, radiofrequency ablation, surgery, etc) < 4 weeks prior to randomization.
9. Major surgery < 12 weeks prior to randomization.
10. Previous radiotherapy of any kind which has resulted in irradiation of both kidneys and/or > 50% of the red bone marrow.
11. Any other serious, uncontrolled medical or psychiatric condition including other advanced or metastatic malignant disease that, in the opinion of the investigator, precludes the patient from participation in the trial
12. Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
13. Inability or reluctance to adhere to the radiation safety instructions
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method