ACTRN12622000302752尚未招募未知
Impact of intra-tumour injection of OncoSil (32P) on vascularity, stromal integrity and response to chemotherapy in locally advanced pancreatic carcinoma
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1. Study participants are greater than/equal to 18 years of age at screening.
- •2. Histologically or cytologically proven adenocarcinoma of the pancreas.
- •3. Unresectable locally advanced pancreatic carcinoma. Patients with technically resectable tumours (T1-T3) will also be eligible, if they are deemed unresectable due to medical comorbidities or refusal of surgery.
- •4. Pancreatic target tumour diameter of less than/equal to 6.0 cm (longest axis)
- •5. An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 – 100.
- •6. Standard first line chemotherapy with FOLFIRINOX will be commenced within 14 days post enrolment, with OncoSil implantation to occur during the 4th week from commencement of chemotherapy.
- •7. Willing and able to complete study procedures within the study timelines.
- •8. Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN).
- •9. Adequate liver function: Serum SGOT/AST and serum SGPT/SLT less than 3 times ULN and serum bilirubin less than 1.5 times the ULN unless the patient is known to have prior Gilbert’s Syndrome.
- •10. Adequate bone marrow function: white blood cells (WBCs) greater than/equal to 3,000/mm3, absolute neutrophil count (ANC) greater than/equal to 1,500/mm3, haemoglobin greater than/equal to 9 g/dL, and platelets greater than/equal to 100,000/mm3.
- •11. Life expectancy of at least 3 months at the time of screening as judged by the investigator.
- •12. Not pregnant, and if of childbearing potential, agrees to use adequate birth control (hormonal or barrier method of birth control or abstinence) prior to study entry and during the study and agrees not to donate sperm or ova, for the duration of the study and 12 months post implantation of the investigational device.
- •13. Provide signed Informed Consent.
- •14. Technically feasible – tumour must be within reach of the EUS probe for fine needle injection
排除标准
- •1. Evidence of distant metastases
- •2. More than one primary lesion.
- •3. Any prior radiotherapy or chemotherapy for pancreatic cancer.
- •4. Use of other investigational agent at the time of screening, or within 30 days or five half-lives of Screening Visit 1, whichever is longer.
- •5. Pregnant or lactating.
- •6. History of malignancy, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ.
- •7. Evidence of tumour invasion into stomach, duodenum or peritoneum
- •8. In the opinion of the investigator, EUS directed implantation posing undue study participant risk. This includes:
- •(a) Where previous EUS-FNA was considered technically too difficult to perform;
- •(b) Imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;
- •(c)Presence (or significant risk) of varices near to the target tumour.
- •9. A known allergy or history of hypersensitivity to silicon, Phosphorus or any of the OncoSil™ components.
- •10. Patients who do not consent to chemotherapy
- •11. Actively on medication that increase bleeding risk (i.e. aspirin, clopidogrel, warfarin, NOAC)
- •12. Any other health condition that would preclude participation in the study in the judgment of the investigator.
研究者
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