跳至主要内容
临床试验/NCT04033991
NCT04033991已完成不适用

A Real World Retrospective Database Study of Patients Diagnosed With Metastatic and/or Advanced Renal Cell Carcinoma and Treated With Sunitinib and/or Axitinib in a Specialist United Kingdom Oncology Centre

Pfizer1 个研究点 分布在 1 个国家目标入组 684 人开始时间: 2019年9月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
684
试验地点
1
主要终点
Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification

研究概览

简要总结

Research Questions:

To understand the clinical outcomes of patients treated with sunitinib in first line and axitinib in second line in a real world setting as therapies for metastatic and/or advanced renal cell carcinoma (mRCC).

Primary Objective:

  1. What is the progression free survival (PFS) of patients treated in first line with sunitinib, and stratified by Memorial Sloan-Kettering Cancer Center / International Metastatic Renal Cell Carcinoma Database Consortium (MSKCC/IMDC) risk category (favourable, intermediate, poor)?
  2. What is the progression free survival (PFS) of patients treated in second line with axitinib, and stratified by MSKCC/IMDC risk category (favourable, intermediate, poor)?

详细描述

Research Questions:

To understand the clinical outcomes of patients treated with sunitinib in first line and axitinib in second line in a real world setting as therapies for metastatic and/or advanced renal cell carcinoma (mRCC).

Primary Objective:

  1. What is the progression free survival (PFS) of patients treated in first line with sunitinib, and stratified by Memorial Sloan-Kettering Cancer Center / International Metastatic Renal Cell Carcinoma Database Consortium (MSKCC/IMDC) risk category (favourable, intermediate, poor)?
  2. What is the progression free survival (PFS) of patients treated in second line with axitinib, and stratified by MSKCC/IMDC risk category (favourable, intermediate, poor)?

Secondary Objectives:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Patients with advanced RCC

Patients with a diagnosis of kidney cancer (renal cell carcinoma, advanced or metastatic)

干预措施: Sunitinib (Drug)

Patients with advanced RCC

Patients with a diagnosis of kidney cancer (renal cell carcinoma, advanced or metastatic)

干预措施: Axitinib (Drug)

结局指标

主要结局

Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification

时间窗: From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)

PFS: first date of each treatment line to the date of PD, end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from date of PD or end of treatment date was assigned. MSKCC criteria had 5 risk factors: Karnofsky performance status (KPS) \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; hemoglobin \<lower limit of normal (LLN); lactate dehydrogenase 1.5\*upper limit of normal (ULN); corrected serum calcium \>10 milligram per deciliter (mg/dL). Present risk factors were added, and participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors). PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was considered PD.

Progression Free Survival (PFS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification

时间窗: From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)

PFS: duration measured from first date of each treatment line to the date of PD, end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from date of PD or end of treatment date was assigned. IMDC criteria had 6 risk factors: KPS \<80% (ability to perform ordinary tasks, 0 \[dead\] -100 \[normal\]); time from diagnosis to start of systemic therapy \<12 months; corrected serum calcium \>10 mg/dL; neutrophils and platelets \>LLN; hemoglobin \<LLN. Present risk factors were added, and then participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (\>=3 factors). PD: \>=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered PD.

Progression Free Survival (PFS)

时间窗: From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years)

PFS was duration measured from the first date of each treatment line to the date of disease progression (PD), end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from the date of progression or end of treatment date was assigned. PD per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression.

次要结局

  • Overall Survival (OS)(From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years))
  • Time to Treatment Discontinuation (TTD)(From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years))
  • Time to Treatment Discontinuation (TTD): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification(From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years))
  • Durable Response Rate (DRR)(6 months from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years))
  • Overall Survival (OS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification(From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years))
  • Duration of Response (DOR)(From date of first documented CR/PR until PD/death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16years (data retrieved and observed retrospectively for approximately 1.2 years))
  • Overall Survival (OS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification(From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years))
  • Number of Participants With Best Overall Response (BOR) for Complete Response (CR), Partial Response (PR), Stable Disease (SD), PD and Surgical CR as Per RECIST v 1.1(Start of treatment till BOR of CR, PR, PD, SD, Surgical CR, or death/initiation of new therapy, whichever occurred first; from 2002 to 30 June 2018, anytime in these 16 years (data retrieved and observed retrospectively for approximately 1.2 years))
  • Objective Response Rate (ORR)(From start of treatment until CR,PR,PD,death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16 years (from data retrieved and observed retrospectively for approximately 1.2 years))
  • Time to Treatment Discontinuation (TTD): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification(From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years))

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

终止
不适用
Real-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as First Line Therapy.Metastatic Renal Cell Carcinoma
NCT03140176Pfizer77
已完成
2 期
Sunitinib Non Small Cell Lung Cancer Patients Over 70Non Small Cell Lung Cancer
NCT00864721US Oncology Research63
已完成
2 期
Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable MeningiomaCNS CancerIntracranial HemangiopericytomaHemangioblastomaMeningiomaNeurofibromatosis
NCT00589784Memorial Sloan Kettering Cancer Center50
已完成
2 期
Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine TumorsPancreatic Neuroendocrine Tumors
NCT01121562Pfizer12
已完成
1 期
Sunitinib Malate in Treating HIV-Positive Patients With Cancer Receiving Antiretroviral TherapyAccelerated Phase Chronic Myelogenous LeukemiaAcute Undifferentiated LeukemiaAcute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic SyndromeAdult Acute Lymphoblastic Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Adult Grade III Lymphomatoid GranulomatosisAdult Langerhans Cell HistiocytosisAdult Nasal Type Extranodal NK/T-cell LymphomaAggressive NK-cell LeukemiaAIDS-related Diffuse Large Cell LymphomaAIDS-related Diffuse Mixed Cell LymphomaAIDS-related Diffuse Small Cleaved Cell LymphomaAIDS-related Immunoblastic Large Cell LymphomaAIDS-related Lymphoblastic LymphomaAIDS-related MalignanciesAIDS-related Small Noncleaved Cell LymphomaAnaplastic Large Cell LymphomaAngioimmunoblastic T-cell LymphomaAtypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeChronic Neutrophilic LeukemiaChronic Phase Chronic Myelogenous LeukemiaCutaneous B-cell Non-Hodgkin Lymphomade Novo Myelodysplastic SyndromesExtramedullary PlasmacytomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHepatosplenic T-cell LymphomaHIV InfectionHIV-associated Hodgkin LymphomaIntraocular LymphomaIsolated Plasmacytoma of BoneLight Chain Deposition DiseaseMyelodysplastic Syndrome With Isolated Del(5q)Myelodysplastic/Myeloproliferative Neoplasm, UnclassifiableMyeloid/NK-cell Acute LeukemiaNodal Marginal Zone B-cell LymphomaNoncutaneous Extranodal LymphomaOsteolytic Lesions of Multiple MyelomaPeripheral T-cell LymphomaPlasma Cell NeoplasmMast Cell LeukemiaChronic Eosinophilic LeukemiaPreviously Treated Myelodysplastic SyndromesPrimary Systemic AmyloidosisProgressive Hairy Cell Leukemia, Initial TreatmentRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaEssential ThrombocythemiaProlymphocytic LeukemiaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Renal Cell CancerRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRefractory Multiple MyelomaRelapsing Chronic Myelogenous LeukemiaStage IV Renal Cell CancerT-cell Large Granular Lymphocyte LeukemiaTesticular LymphomaUnspecified Adult Solid Tumor, Protocol SpecificWaldenström MacroglobulinemiaChronic Myelomonocytic LeukemiaPolycythemia VeraPrimary MyelofibrosisClear Cell Renal Cell CarcinomaPost-transplant Lymphoproliferative Disorder
NCT00890747National Cancer Institute (NCI)42