CTRI/2021/12/038483进行中（未招募）3 期
A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy with Lutetium (177Lu) Edotreotide versus Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor positive, Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin. - COMPOSE
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
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
入选标准
- •1) Provided written informed consent.
- •2) Histologically confirmed diagnosis of unresectable, well-differentiated GEP-NETs, with a Ki-67 index between 15 and 55, inclusive. This should be at least confirmed by a local pathological report of a biopsy specimen of the primary tumor or metastasis, or,if unavailable, willingness to undergo current biopsy for local analysis before randomization.
- •3) In the investigator’s opinion, eligible to receive treatment with at least one of the following: CAPTEM, everolimus or FOLFOX according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations or the local guidelines.
- •4) At least 1 measurable site of disease per RECIST v1.1 using contrast CT/MRI. Patients who are allergic to IV contrast may be imaged without.
- •6) SSTR+ disease, as evidenced by 68Ga-based or 64Cu-based (if approved according to local regulations) SSTR PET SRI (68Ga-DOTATOC, 68Ga-DOTATATE or 64Cu-DOTATATE) within 4 months prior to randomization and as close as possible to the fluorodeoxyglucose (FDG) PET.
- •a) The majority of the CT/MRI lesions have to be SSTR+.
- •b) The SSTR PET SRI should be repeated at randomization if the scan is not within 28 days of the randomization date.
- •7) All patients need to undergo a FDG PET scan within 4 months prior to randomization and as close as possible to the PET SRI.
- •a) The majority of FDG PET-positive lesions have to be SSTR+.
- •8) Patients may be treatment naïve (first-line) or have a maximum of one prior line of therapy, including SSAs, (second-line).
- •a) Patients on any prior antineoplastic therapy (including SSAs) must have radiological disease progression (according to RECIST v1.1) within the 4 months prior to randomization, based on the investigator’s assessment.
- •b) Patients who progress on SSAs may enter the trial continuing on the same dose if required for symptom control.
- •9) Karnofsky performance status (KPS) scale = 60 (see Appendix 3).
排除标准
- •1) Known hypersensitivity to lutetium-177 (177Lu), edotreotide, DOTA, any of the comparators the comparator, or any excipient or derivative (e.g. rapamycin).
- •2) Known hypersensitivity to lysine, arginine, or any excipient of the nephroprotective AAS given concurrently with the lutetium (177Lu) edotreotide infusion.
- •3) Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow.
- •4) Prior selective internal radiation therapy (SIRT).
- •5) Prior peptide receptor radionuclide therapy (PRRT).
- •6) Received chemotherapy, mTOR inhibitors, vascular endothelial growth factor (VEGF) pathway inhibitors, immunotherapy, interferon, chemo-embolization, bland embolization, cyclosporine A, locoregional treatment (e.g. cytoreduction surgery, radiofrequency ablation [RFA], liver directed intra-arterial intervention) or SSAs within 4 weeks prior to randomization into the trial. Patients may be treated with SSAs for symptom control, but they must have remained on the same dose of the SSA as at the time of demonstrated disease progression.
- •7) Any major surgery within 4 weeks prior to randomization in the trial.
- •8) Therapy with an investigational compound and/or medical device within 30 days or
- •7 half-life periods (whichever is longer) prior to randomization.
- •9) Patients who have received a live attenuated vaccine up to 4 weeks prior to randomization.
- •10) Patients with brain metastases.
- •11) Other known malignancies (except non-invasive skin cancer and carcinoma of the cervix in situ), unless definitively treated and proven no evidence of recurrence for 5 years.
- •12) Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune, metabolic or dementia), that may interfere with the objectives of the trial or with the safety or compliance of the patient, as judged by the investigator.
- •13) Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments, as follows:
- •a) Renal - GFR < 50 mL/min/1.73 m2 (calculated by the Chronic Kidney DiseaseEpidemiology Form [CKD-EPI] formula [local laboratory]), Creatinine clearance < 50 mL/min calculated by the Cockcroft Gault method, Renal tract obstruction.
- •b) Hepatic, Total bilirubin > 3 × upper limit of normal (ULN), Albumin < 30 g/L, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 5 × ULN, Known ascites
- •c) Cardiovascular, Heart failure (New York Heart Association [NYHA] classification III and IV), Uncontrolled hypertension, Hematopoietic, Platelets = 75 × 109/L, Absolute neutrophil count (ANC) < 1.5 × 109 cells/L, Hemoglobin (Hb) concentration < 5.0 mmol/L ( < 8.0 g/dL)
- •e) Any other ongoing hematological or renal Grade 2 toxicity or other Grade 3 toxicity from previous standard or investigational therapies (NCI-Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
- •14) Current spontaneous urinary incontinence.
- •15) Pregnancy and breast-feeding: Female patients of childbearing potential or male patients with female partners of childbearing potential, unless willing to practice full and true sexual abstinence or who are surgically/permanently sterile (hysterectomy, or vasectomy), or female patients whose male partners have medically successful vasectomy (provided the partner is the sole sexual partner of the female patient of childbearing potential), or who are not w
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