EUCTR2023-000086-14-IT招募中1 期
Receptor radionuclide therapy with 177Lu-DOTATOC (177Lu-edotreotide or 177Lu-octreotide) in SSTR positive patients: a multicenter, prospective, phase II trial - LUFOR
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 个研究点目标入组 268 人开始时间: 2023年1月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 268
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1) Age =18 years.
- •2) Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histology type documented as sst2-positive, that may benefit from receptor radionuclide therapy and for which there aren’t any other effective treatments. For cerebral and PPGLs sst2-positive tumors, if biopsy is no feasible for technical reason or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion confirming the 68Ga PET-CT dota-peptide SSTr2 positivity.
- •3) Measurable disease according to RECIST 1.1 criteria also patients without measurable but with evaluable disease can be enrolled.
- •4) Any disease stage is allowed. Patients with documented disease will be admitted to the therapeutic phase only if the diagnostic PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour.
- •5) Patients with progressive disease in pre-study period (PD within the last 12 months), refractory to conventional standard treatments; clinical progression is allowed.
- •6) Patients with or without concurrent therapy with somatostatin analogs.
- •7) Life expectancy of greater than 6 months.
- •8) ECOG performance status =2.
- •9) Adequate haematological, liver and renal function: haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin =1.5 X UNL (upper normal limit), ALT and AST <2.5 X UNL (< 5 X UNL in presence of liver metastases), creatinine < 2 mg/dL.
- •10) If female of childbearing potential highly effective birth control methods, according to guideline Recommendation related to contraception and pregnancy testing in clinical trials”, (2014_09_15 section 4.1) are mandatory (see Appendix F). Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment.
- •11) Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required ( established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), for more than 6 months (see Appendix F).
- •12) Participant is willing and able to give informed consent for participation in the study.
- •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 134
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 134
排除标准
- •1) Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy.
- •2) Patients treated with previous PRRT with an absorbed dose to the kidney more than 23 Gy and more than 1.8 Gy for the bone marrow or as surrogate of dosimetry.
- •3) Patients which are included in the indication of LUTATHERA®
- •4) All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade = 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE).
- •5) ECOG performance status >2.
- •6) Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- •7) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •8) Assessed bone marrow invasion > 50% (with Bone Marrow biopsy or instrumental exams i.e bone scan or CT or MRI).
- •9) Pregnant or breastfeeding women are excluded from the present study.
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