CHARM 2: Chemotherapy for ablation and resolution of mucinous pancreatic cysts: a prospective, randomized, double-blind, multi-center clinical trial
魅力 2:化疗消融和解决粘液性胰腺囊肿:一项前瞻性、随机、双盲、多中心临床试验
基本信息
- 批准号:10002201
- 负责人:
- 金额:$ 43.15万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-08-01 至 2023-07-31
- 项目状态:已结题
- 来源:
- 关键词:Abdominal PainAblationAdmixtureAdultAdverse eventAlcohol consumptionAspirate substanceCancer EtiologyCaringCessation of lifeClinicalCombination Drug TherapyCystCystic LesionDiagnosisDiagnostic radiologic examinationDouble-Blind MethodDyesEarly InterventionEndoscopic UltrasonographyEndoscopyEpidemicEstrogen receptor positiveEthanolExcisionExtravasationFundingGastroenterologyGeneral PopulationHospitalizationImageImaging TechniquesIn complete remissionIncidenceInfusion proceduresInjectionsInterventionInvestigationIrrigationLesionLinkMagnetic Resonance ImagingMalignant - descriptorMalignant NeoplasmsMalignant neoplasm of pancreasMethodsModalityMucinousMulti-Institutional Clinical TrialMulticenter TrialsNeedlesNewly DiagnosedOperative Surgical ProceduresPaclitaxelPancreatectomyPancreatic CystPancreatic cystic neoplasiaPatientsPharmacologyPilot ProjectsPrevalenceProceduresPublic HealthPublishingQualifyingRandomizedRandomized Controlled TrialsRelative RisksResearchResolutionRiskSafetySalineSurgical OncologyTestingTimeTissuesUnited StatesWeightX-Ray Computed Tomographyacute pancreatitisadverse event riskaging populationbasechemotherapeutic agentchemotherapyclinically significantcostdesigneffective therapyexperiencefollow-upgemcitabinehigh riskmalignant breast neoplasmmortalitymultidisciplinarynovelpremalignantprospectivepublic health relevancerandomized trialstandard of caresuccesstreatment comparisontreatment grouptreatment strategytrial comparingtwo-arm study
项目摘要
Pre-malignant pancreatic cysts that are difficult to characterize and treat are increasingly
discovered in the US over the last two decades due to advances in imaging and an aging
population. With the incidence of highly lethal pancreatic cancer rising in the US, intervening on
pancreatic cysts with malignant potential in a safe and effective way is a major public health
concern. While patients have been historically limited to radiographic surveillance or potentially
hazardous surgery as undesirable methods of managing these cysts, endoscopic ultrasound
guided fine needle injection (EUS-FNI) has emerged as a less-invasive, safe and effective
method of early intervention. For EUS-guided treatment of pancreatic cysts today, care typically
includes lavage with ethanol. However, experts agree that adverse events (AEs) observed
during treatment are due to ethanol use. Recently, based on the safety concerns surrounding
ethanol use, as well as the promising treatment findings linked to the infusion of paclitaxel, our
team created an ethanol-free (EF), combination chemotherapy treatment consisting of an
admixture—paclitaxel and gemcitabine—specifically designed to target pancreatic cystic
neoplasia by EUS-guided injection. Our team completed testing of this novel treatment strategy
in 2017 as a preliminary randomized trial, showing that EF lavage (i.e., saline) with combination
chemotherapy was as effective, and far safer, than the same chemotherapy treatment with the
inclusion of ethanol lavage (EL). In this proposal, our aim is increase the scale of our pilot study,
conducting a large and definitive multi-center trial that will be the first funded RCT to compare
treatment with EL to ethanol-free (EF) treatment with combination infusion of chemotherapeutic
agents. All subjects will have qualifying cystic lesions aspirated and evacuated, and undergo a
follow-up procedure at 3 months and final imaging at 12 months. We will randomly assign 100
adult patients with pancreatic cysts to two study arms: (1) Ethanol lavage (EL): EL, followed by
infusion of a paclitaxel-gemcitabine admixture, or (2) Ethanol Free (EF): saline lavage, followed
by infusion of the same paclitaxel-gemcitabine admixture. We hypothesize that EF treatment will
result in significantly fewer adverse events and will have complete cyst ablation resolution rates
that are not inferior to EL treatment. If the EF intervention proves to be non-inferior to, and
significantly safer than, treatment with EL, it will validate EUS-FNI as a viable treatment modality
for intervening on pre-malignant cysts and will change the standard of care for pancreatic cyst
management. Critically, if EF treatment is successful, it may alter the treatment decisions that
patients make and change the treatment options that centers of excellence offer.
难以表征和治疗的癌前胰腺囊肿越来越多
由于成像技术的进步和老化,过去二十年在美国发现了
随着美国高致命性胰腺癌发病率的上升,需要进行干预。
安全有效地治疗具有恶变潜力的胰腺囊肿是一项重大公共卫生问题
虽然患者历来仅限于放射线监测或可能。
危险的手术作为处理这些囊肿的不良方法,内窥镜超声
引导细针注射(EUS-FNI)已成为一种微创、安全、有效的方法
如今,对于 EUS 引导下的胰腺囊肿治疗,通常需要进行护理。
包括用乙醇灌洗,但是专家们一致认为观察到了不良事件 (AE)。
最近,基于周围的安全问题,治疗期间使用了乙醇。
乙醇的使用,以及与紫杉醇输注相关的有希望的治疗结果,我们的
研究小组创建了一种无乙醇 (EF) 联合化疗疗法,其中包括
混合物——紫杉醇和吉西他滨——专门针对胰腺囊性病变而设计
我们的团队完成了这种新型治疗策略的测试。
2017 年的一项初步随机试验表明,EF 灌洗(即生理盐水)与组合
化疗与相同的化疗方法相比,同样有效,而且安全得多。
在本提案中,我们的目标是扩大试点研究的规模,
进行一项大型且明确的多中心试验,这将是第一个资助的随机对照试验
EL 治疗至无乙醇 (EF) 治疗联合输注化疗药物
所有受试者都将进行合格的囊性病变抽吸和排空,并接受检查。
3 个月时进行随访,12 个月时进行最终成像,我们将随机分配 100 名。
患有胰腺囊肿的成年患者分为两个研究组:(1) 乙醇灌洗 (EL):EL,然后
输注紫杉醇-吉西他滨混合物,或 (2) 无乙醇 (EF):盐水灌洗,然后
通过输注相同的紫杉醇-吉西他滨混合物,我们认为 EF 治疗会有效。
导致显着不良事件更少,并具有完全囊肿消融解决率
不劣于 EL 治疗 如果 EF 干预措施被证明不劣于,并且
比 EL 治疗安全得多,它将验证 EUS-FNI 作为一种可行的治疗方式
用于对癌前囊肿进行干预并将改变胰腺囊肿的护理标准
至关重要的是,如果 EF 治疗成功,可能会改变治疗决策。
患者制定并改变卓越中心提供的治疗方案。
项目成果
期刊论文数量(0)
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John M DeWitt其他文献
John M DeWitt的其他文献
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{{ truncateString('John M DeWitt', 18)}}的其他基金
CHARM 2: Chemotherapy for ablation and resolution of mucinous pancreatic cysts: a prospective, randomized, double-blind, multi-center clinical trial
魅力 2:化疗消融和解决粘液性胰腺囊肿:一项前瞻性、随机、双盲、多中心临床试验
- 批准号:
10478007 - 财政年份:2018
- 资助金额:
$ 43.15万 - 项目类别:
CHARM 2: Chemotherapy for ablation and resolution of mucinous pancreatic cysts: a prospective, randomized, double-blind, multi-center clinical trial
魅力 2:化疗消融和解决粘液性胰腺囊肿:一项前瞻性、随机、双盲、多中心临床试验
- 批准号:
9750284 - 财政年份:2018
- 资助金额:
$ 43.15万 - 项目类别:
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