A Translational Study of Bevacizumab in Participants With Metastatic Colorectal Cancer (ASCENT)
2018년 8월 17일 업데이트: Hoffmann-La Roche
An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab (Avastin™)
This open-label, prospective, single-arm, multicenter study will evaluate the relationship of the markers of inflammation and progression-free survival (PFS) in participants with previously untreated metastatic colorectal cancer.
The study consists of two phases: Phase A treatment: oral capecitabine plus infusional oxaliplatin (XELOX) plus bevacizumab, or modified infusional 5-fluorouracil (5-FU), leucovorin (LV) and oxaliplatin (mFOLFOX6) plus bevacizmab administered until first disease progression.
Participants will then continue with Phase B treatment: infusional 5-FU, LV and irinotecan (FOLFIRI) plus bevacizumab until second disease progression.
The anticipated time on study treatment is 4 years.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
128
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Australian Capital Territory
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Garran, Australian Capital Territory, 호주, 2605
- Canberra Hospital
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New South Wales
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Campbelltown, New South Wales, 호주, 2560
- Macarthur Cancer Therapy Centre
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Camperdown, New South Wales, 호주, 2050
- Chris O'Brien Lifehouse
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Darlinghurst, New South Wales, 호주, 2010
- St Vincent'S Hospital; Clinical Oncology
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Port Macquarie, New South Wales, 호주, 2444
- Mid North Coast Cancer Institute
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St Leonards, New South Wales, 호주, 2065
- Royal North Shore Hospital; Department of Medical Oncology
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Sydney, New South Wales, 호주, 2076
- Sydney Adventist Hospital; Clinical Trial Unit
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Queensland
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Brisbane, Queensland, 호주, 4029
- Royal Brisbane Hospital
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Rockhampton, Queensland, 호주, 4700
- Rockhampton Hospital
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Townsville, Queensland, 호주, 4812
- The Townsville Hospital; Townsville Cancer Centre
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South Australia
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Elizabeth Vale, South Australia, 호주, 5112
- Lyell McEwin Hospital; Oncology Clinical Trials, Chemotherapy Day Unit
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North Adelaide, South Australia, 호주, 5006
- Calvary North Adelaide; North Adeliade Oncology Centre
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Tasmania
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Launceston, Tasmania, 호주, 7250
- Launceston General Hospital
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Victoria
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Heidelberg, Victoria, 호주, 3084
- Austin Hospital; Medical Oncology
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St Albans, Victoria, 호주
- Sunshine Hospital; Oncology Research
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Western Australia
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Murdoch, Western Australia, 호주, 6150
- St John of God Murdoch Hospital; Oncology West
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Subiaco, Western Australia, 호주, 6008
- St John of God Hospital; Bendat Cancer Centre
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
For resected primary tumor participants, and participants with primary tumor in situ:
- Previously untreated metastatic colorectal cancer and not a candidate for curative resection
- World Health Organization (WHO) performance status of 0-1
- Life expectancy of greater than or equal to (>/=) 3 months
- Eligible for XELOX, mFOLFOX6, FOLFIRI and bevacizumab treatment in accordance with local standards of care and pharmaceutical benefits scheme guidelines
Additional inclusion criteria for participants with primary tumor in situ:
- Intact primary tumor of the colon or the rectum not requiring surgical intervention prior to study start
- Minimal or asymptomatic primary tumor
Exclusion Criteria:
Resected primary tumor participants, and participants with primary tumor in situ:
- Previous chemotherapy for metastatic colorectal cancer
- Previous neoadjuvant or adjuvant chemotherapy less than 6 months prior to study start
- Radiotherapy within 28 days prior to enrollment or not recovered from a radiotherapy
- History of non-colorectal cancer (participants are eligible if disease-free for >/=5 years and the risk of recurrence is deemed low)
- Presence of active inflammatory bowel disease
- History of gastrointestinal perforations
- Peritoneal disease
- History of significant bleeding event
- Significant vascular disease
- Peripheral arterial thrombosis or other thrombotic event within 6 months before study start
Additional exclusion criteria for participants with primary tumor in situ:
- Prior endoscopic management of the current tumor
- Acute diverticulitis
- Presence of intra-abdominal abscess
- Active gastroduodenal ulcer
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Bevacizumab: Phase A and Phase B
The trial will consist of 2 phases of treatment.
Phase A: Participants will receive bevacizumab 7.5 mg/kg intravenous (IV) infusion on Day 1 every 3 weeks in combination with XELOX (capecitabine and oxaliplatin) or bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with mFOLFOX6 (oxaliplatin, leucovorin, and 5-fluouracil) until first disease progression or occurrence of unmanageable toxicity.
Phase B: Upon documented first disease progression, participants will continue receiving bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with FOLFIRI (irinotecan, leucovorin, and 5-fluouracil) until second disease progression or occurrence of unmanageable toxicity.
Phase B treatment should commence within 4 weeks of the date of documented first disease progression.
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Participants will receive oxaliplatin 85 milligrams per square meter (mg/m^2) IV infusion on Day 1 of every 2 weeks cycle during alternative Phase A treatment or 130 mg/m^2 on Day 1 of every 3 weeks cycle during Phase A treatment.
Participants will receive capecitabine 1000 mg/m^2 per oral (PO) twice daily on Days 1-14 of 3 weeks cycle during Phase A treatment.
Participants will receive 7.5 mg/kg IV infusion on Day 1 every 3 weeks (Phase A treatment) or 5 mg/kg IV on Day 1 every 2 weeks (Alternative Phase A treatment and Phase B).
다른 이름들:
Participants will receive leucovorin 400 mg/m^2 IV on Day 1 every 2 weeks (Alternative Phase A treatment and Phase B).
Investigators may elect to chose low dose of leucovorin (either 20 mg/m^2 or 50 mg total dose).
Participants will receive 5-fluouracil loading dose of 400 mg/m^2 IV on Day 1 followed by 2400 mg/m^2 continuous IV infusion over 46 hours Day 1 (Alternative Phase A treatment and Phase B).
Participants will receive irinotecan 180 mg/m^2 IV on Day 1 every 2 weeks during Phase B treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Association Between Neutrophil to Lymphocyte Ratio (NLR) [NLR ≤5 Versus NLR >5] and Progression-Free Survival (PFS) as Assessed by Hazard Ratio
기간: Baseline up to disease progression, death or end of study (up to 4 years)
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NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes.
PFS was defined as the time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first.
Disease progression was determined according to standard practice based on radiological, biochemical (carcinoembryonic antigen [CEA]) or clinical factors.
Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration.
The association between NLR (NLR less than or equal to [≤] 5 vs greater than [>] 5) and PFS was reported as hazard ratio.
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Baseline up to disease progression, death or end of study (up to 4 years)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PFS Until First Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase A
기간: Baseline up to first disease progression, death or end of study (up to 4 years)
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PFS until first progression was defined as the time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first.
Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors.
Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration.
Kaplan-Meier methodology was used to estimate PFS.
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Baseline up to first disease progression, death or end of study (up to 4 years)
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PFS Until Second Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase B
기간: From the start of Phase B treatment to disease progression, death or end of study (up to 4 years)
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PFS in Phase B (PFS-B) was defined as the time from the start of Phase B treatment to documentation of second disease progression or death from any cause, whichever occurred first.
Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors.
Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration.
Kaplan-Meier methodology was used to estimate PFS.
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From the start of Phase B treatment to disease progression, death or end of study (up to 4 years)
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Time to Failure of Strategy (TFS): Overall
기간: Baseline up to disease progression, death or end of study (up to 4 years)
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TFS was defined as time from the start of initial treatment to documentation of first disease progression without entering Phase B, or second disease progression having entered Phase B. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors.
Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration.
Kaplan-Meier methodology was used to estimate TFS.
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Baseline up to disease progression, death or end of study (up to 4 years)
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Duration of Disease Control (DDC) as Assessed by the Investigator Based on Routine Clinical Practice: Overall
기간: Baseline up to disease progression, death or end of study (up to 4 years)
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DDC was defined as PFS + PFS-B.
In cases where a participant did not enter Phase B, then DDC was defined as PFS.
PFS was defined as time from start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first.
PFS-B was time from start of Phase B treatment to documentation of second disease progression or death from any cause, whichever occurred first.
Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors.
Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration.
Kaplan-Meier methodology was used to estimate DDC.
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Baseline up to disease progression, death or end of study (up to 4 years)
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Overall Survival (OS) From the Start of Treatment to Study Completion: Overall
기간: Baseline until death or end of study (up to 4 years)
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OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death.
Kaplan-Meier methodology was used to estimate OS.
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Baseline until death or end of study (up to 4 years)
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Survival Beyond First Disease Progression: Overall
기간: Baseline until death or end of study (up to 4 years)
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Survival beyond first progression was defined as the time from the date of first disease progression to death due to any cause.
Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors.
Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration.
Kaplan-Meier methodology was used to estimate survival beyond first disease progression.
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Baseline until death or end of study (up to 4 years)
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OS: Phase B
기간: From the start of Phase B treatment death or end of study (up to 4 years)
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Overall Survival in Phase B was defined as the time from the start of treatment in Phase B to death due to any cause.
Kaplan-Meier methodology was used to estimate OS.
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From the start of Phase B treatment death or end of study (up to 4 years)
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Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase A
기간: Baseline up to disease progression, death or end of study (up to 4 years)
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Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported.
The confirmation of response must be no less than 4 weeks after initial assessment.
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Baseline up to disease progression, death or end of study (up to 4 years)
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Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase B
기간: From the start of Phase B treatment to disease progression, death or end of study (up to 4 years)
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Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported.
The confirmation of response must be no less than 4 weeks after initial assessment.
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From the start of Phase B treatment to disease progression, death or end of study (up to 4 years)
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Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Overall
기간: Baseline up to disease progression, death or end of study (up to 4 years)
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Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported.
The confirmation of response must be no less than 4 weeks after initial assessment.
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Baseline up to disease progression, death or end of study (up to 4 years)
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Percentage of Participants Who Underwent Liver Resection: Overall
기간: Baseline up to disease progression, death or end of study (up to 4 years)
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The results include percentage of participants who underwent potentially curative liver resection.
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Baseline up to disease progression, death or end of study (up to 4 years)
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Association Between NLR (NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio
기간: Baseline up to disease progression, death or end of study (up to 4 years)
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NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes.
OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death.
The association between NLR (NLR ≤ 5 vs > 5) and OS was reported as hazard ratio.
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Baseline up to disease progression, death or end of study (up to 4 years)
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Association Between NLR Normalization (First NLR Post-Baseline ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio
기간: Baseline up to disease progression, death or end of study (up to 4 years)
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NLR was calculated from laboratory values as ratio of Neutrophils to Lymphocytes.
NLR normalization was assessed by adding first post-baseline measurement of NLR to the primary model.
This is equivalent to testing whether first change in NLR is significantly associated with outcome.
PFS was defined as time from start of initial treatment to documentation of first disease progression or death from any cause.
Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors.
Determination of disease progression was defined as: an unequivocal and clinically meaningful increase in size of known tumors, appearance of ≥1 new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration.The association between NLR normalization (first NLR post-baseline ≤5 vs >5) and PFS was reported as hazard ratio.
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Baseline up to disease progression, death or end of study (up to 4 years)
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Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio
기간: Baseline up to disease progression, death or end of study (up to 4 years)
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NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes.
Longitudinal NLR was assessed by treating the NLR measurements taken over the time-course of treatment as a time-dependent covariate.
PFS was defined as time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first.
Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors.
Determination of disease progression was to be unequivocal and was defined as: an unequivocal and clinically meaningful increase in size of known tumors, appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration.
The association between longitudinal NLR (longitudinal NLR ≤5 vs N>5) and PFS was reported as hazard ratio.
|
Baseline up to disease progression, death or end of study (up to 4 years)
|
|
Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio
기간: Baseline up to death or end of study (up to 4 years)
|
NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes.
Longitudinal NLR was assessed by treating the NLR measurements taken over the time-course of treatment as a time-dependent covariate.
OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death.
The association between longitudinal NLR (longitudinal NLR ≤5 vs NLR >5) and OS was reported as hazard ratio.
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Baseline up to death or end of study (up to 4 years)
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European Quality of Life 5-Dimension (EuroQol-5D) Utility Score: Phase A
기간: Baseline, every 8-9 weeks thereafter, end of treatment (EOT) (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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EQ-5D is a standardized generic preference based health related quality of life instrument.
It records how one's health is "today" and consists of a descriptive system.
The descriptive system is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression.
Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems).
Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples.
This generates a unique description of the subjects' health status, which is valued between 0 (representing death) and 1 (representing perfect health).
Higher the score, the better the quality of life.
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Baseline, every 8-9 weeks thereafter, end of treatment (EOT) (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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EuroQol-5D Utility Score: Phase B
기간: Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
|
EQ-5D is a standardized generic preference based health related quality of life instrument.
It records how one's health is "today" and consists of a descriptive system.
The descriptive system is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression.
Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems).
Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples.
This generates a unique description of the subjects' health status, which is valued between 0 (representing death) and 1 (representing perfect health).
Higher the score, the better the quality of life.
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Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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Assessment of Quality of Life - Eight Dimensions (AQoL-8D) Global Utility Score: Phase A
기간: Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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AQoL-8D provides a global utility score and comprised of 35 questions from which 8 dimensions (Independent Living, Life Satisfaction, Mental Health, Coping, Relationships, Self Worth, Pain, and Senses) are derived.
Each of the 8 scales is calculated based on the answers to 3 questions.
Each question is given an answer dependent utility score (0 [worst] to 1 [best]) and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health).
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Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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AQoL-8D Global Utility Score: Phase B
기간: Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
|
AQoL-8D provides a global utility score and consists of 8 separately scored dimensions including Independent Living, Life Satisfaction, Mental Health, Coping, Relationships, Self Worth, Pain, and Senses.
Each of the 8 scales is calculated based on the answers to 3 questions.
Each question is given an answer dependent utility score (0 [worst] to 1 [best]) and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health).
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Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Score: Phase A
기간: Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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FACT-C is one part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System, which comprehensively assesses the health-related QoL of cancer participants and participants with other chronic illnesses.
It is composed of 27 items of the general version of the FACT-C as a general core QoL measure and has a disease-specific subscale containing 9 colorectal cancer-specific items.
It consists of total 36 items, summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range from 0 to 28, emotional well-being (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score range: 0 to 144.
High scale score represents a better QoL.
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Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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FACT-C Score: Phase B
기간: Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
|
FACT-C is one part of the FACIT Measurement System, which comprehensively assesses the health-related QoL of cancer participants and participants with other chronic illnesses.
It is composed of 27 items of the general version of the FACT-C as a general core QoL measure and has a disease-specific subscale containing 9 colorectal cancer-specific items.
It consists of total 36 items, summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range from 0 to 28, emotional well-being (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL.
All single-item measures range from 0='Not at all' to 4='Very much'.
Total possible score range: 0 to 144.
High scale score represents a better QoL.
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Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Clarke SJ, Burge M, Feeney K, Gibbs P, Jones K, Marx G, Molloy MP, Price T, Reece WHH, Segelov E, Tebbutt NC. The prognostic role of inflammatory markers in patients with metastatic colorectal cancer treated with bevacizumab: A translational study [ASCENT]. PLoS One. 2020 Mar 6;15(3):e0229900. doi: 10.1371/journal.pone.0229900. eCollection 2020.
- Clarke S, Burge M, Cordwell C, Gibbs P, Reece W, Tebbutt N. An Australian translational study to evaluate the prognostic role of inflammatory markers in patients with metastatic ColorEctal caNcer Treated with bevacizumab (Avastin) [ASCENT]. BMC Cancer. 2013 Mar 15;13:120. doi: 10.1186/1471-2407-13-120.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2012년 6월 26일
기본 완료 (실제)
2016년 9월 15일
연구 완료 (실제)
2016년 9월 30일
연구 등록 날짜
최초 제출
2012년 4월 27일
QC 기준을 충족하는 최초 제출
2012년 4월 30일
처음 게시됨 (추정)
2012년 5월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 1월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 8월 17일
마지막으로 확인됨
2018년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ML25753
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .