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Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

2019년 10월 1일 업데이트: Alliance for Clinical Trials in Oncology

A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

OBJECTIVES:> Primary>

  • Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month, event-free survival, in patients with previously untreated stage II, III, or IV diffuse large B-cell lymphoma.>
  • Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.>
  • Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this regimen.>
  • Assess the safety of this treatment regimen.> Secondary>
  • Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen.> OUTLINE: This is a multicenter study.> Patients receive epratuzumab IV over 1 hour on day 1, rituximab IV over 4-8 hours on day 1 or days 1 and 2, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 or 2, and oral prednisone on days 1-5 or 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.> After completion of study treatment, patients are followed periodically for up to 5 years.> PROJECTED ACCRUAL: A total of 86 patients will be accrued for this study.>

연구 유형

중재적

등록 (실제)

107

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Arizona
      • Scottsdale, Arizona, 미국, 85259-5499
        • Mayo Clinic Scottsdale
    • Colorado
      • Aurora, Colorado, 미국, 80012
        • Aurora Presbyterian Hospital
      • Boulder, Colorado, 미국, 80301-9019
        • Boulder Community Hospital
      • Colorado Springs, Colorado, 미국, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Denver, Colorado, 미국, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, 미국, 80220
        • Rose Medical Center
      • Denver, Colorado, 미국, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, 미국, 80218
        • St. Joseph Hospital
      • Denver, Colorado, 미국, 80224-2522
        • CCOP - Colorado Cancer Research Program
      • Englewood, Colorado, 미국, 80110
        • Swedish Medical Center
      • Fort Collins, Colorado, 미국, 80524
        • Front Range Cancer Specialists
      • Grand Junction, Colorado, 미국, 81502
        • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
      • Lone Tree, Colorado, 미국, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, 미국, 80502
        • Hope Cancer Care Center at Longmont United Hospital
      • Pueblo, Colorado, 미국, 81004
        • St. Mary - Corwin Regional Medical Center
      • Thornton, Colorado, 미국, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, 미국, 80033
        • Exempla Lutheran Medical Center
    • Florida
      • Jacksonville, Florida, 미국, 32224
        • Mayo Clinic - Jacksonville
    • Illinois
      • Aurora, Illinois, 미국, 60507
        • Rush-Copley Cancer Care Center
      • Bloomington, Illinois, 미국, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, 미국, 61520
        • Graham Hospital
      • Carthage, Illinois, 미국, 62321
        • Memorial Hospital
      • Eureka, Illinois, 미국, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, 미국, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, 미국, 61401
        • Galesburg Clinic
      • Havana, Illinois, 미국, 62644
        • Mason District Hospital
      • Hopedale, Illinois, 미국, 61747
        • Hopedale Medical Complex
      • Joliet, Illinois, 미국, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Kewanee, Illinois, 미국, 61443
        • Kewanee Hospital
      • Macomb, Illinois, 미국, 61455
        • Mcdonough District Hospital
      • Moline, Illinois, 미국, 61265
      • Moline, Illinois, 미국, 61265
        • Trinity Medical Center - East
      • Normal, Illinois, 미국, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, 미국, 61761
        • Community Cancer Center
      • Ottawa, Illinois, 미국, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, 미국, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, 미국, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, 미국, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, 미국, 61614
        • Proctor Hospital
      • Peoria, Illinois, 미국, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, 미국, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, 미국, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, 미국, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, 미국, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, 미국, 61362
        • St. Margaret's Hospital
      • Urbana, Illinois, 미국, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, 미국, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Beech Grove, Indiana, 미국, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Michigan City, Indiana, 미국, 46360
        • Saint Anthony Memorial Health Centers
      • Richmond, Indiana, 미국, 47374
        • Reid Hospital & Health Care Services, Incorporated
    • Iowa
      • Ames, Iowa, 미국, 50010
        • McFarland Clinic, PC
      • Des Moines, Iowa, 미국, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, 미국, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, 미국, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, 미국, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, 미국, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, 미국, 50307
        • Mercy Capitol Hospital
      • Des Moines, Iowa, 미국, 50316-2301
        • John Stoddard Cancer Center
      • Mason City, Iowa, 미국, 50401
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
      • Sioux City, Iowa, 미국, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, 미국, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, 미국, 51104
        • Mercy Medical Center - Sioux City
    • Kansas
      • Chanute, Kansas, 미국, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, 미국, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, 미국, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Kingman, Kansas, 미국, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Liberal, Kansas, 미국, 67901
        • Southwest Medical Center
      • Newton, Kansas, 미국, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, 미국, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, 미국, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, 미국, 67042
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, 미국, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, 미국, 67203
        • Associates in Womens Health, PA - North Review
      • Wichita, Kansas, 미국, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, 미국, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, 미국, 67214
        • CCOP - Wichita
      • Wichita, Kansas, 미국, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Winfield, Kansas, 미국, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Michigan
      • Adrian, Michigan, 미국, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Lambertville, Michigan, 미국, 48144
        • Haematology-Oncology Associates of Ohio and Michigan, PC
      • Monroe, Michigan, 미국, 48162
        • Community Cancer Center of Monroe
      • Monroe, Michigan, 미국, 48162
        • Mercy Memorial Hospital - Monroe
    • Minnesota
      • Alexandria, Minnesota, 미국, 56308
      • Bemidji, Minnesota, 미국, 56601
        • MeritCare Bemidji
      • Burnsville, Minnesota, 미국, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, 미국, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, 미국, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, 미국, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Duluth, Minnesota, 미국, 55805
        • Miller - Dwan Medical Center
      • Edina, Minnesota, 미국, 55435
        • Fairview Southdale Hospital
      • Fergus Falls, Minnesota, 미국, 56537
      • Fridley, Minnesota, 미국, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, 미국, 55350
        • Hutchinson Area Health Care
      • Litchfield, Minnesota, 미국, 55355
        • Meeker County Memorial Hospital
      • Maplewood, Minnesota, 미국, 55109
        • Minnesota Oncology Hematology, PA - Maplewood
      • Maplewood, Minnesota, 미국, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Minneapolis, Minnesota, 미국, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Minneapolis, Minnesota, 미국, 55415
        • Hennepin County Medical Center - Minneapolis
      • Montevideo, Minnesota, 미국, 56265
        • Chippewa County - Montevideo Hospital and Medical Center
      • Robbinsdale, Minnesota, 미국, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
      • Rochester, Minnesota, 미국, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, 미국, 56303
        • CentraCare Clinic - River Campus
      • Saint Cloud, Minnesota, 미국, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, 미국, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, 미국, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, 미국, 55102
        • United Hospital
      • Saint Paul, Minnesota, 미국, 55101
        • Regions Hospital Cancer Care Center
      • Saint Paul, Minnesota, 미국, 55102
        • HealthEast Cancer Care at St. Joseph's Hospital
      • Shakopee, Minnesota, 미국, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • Waconia, Minnesota, 미국, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, 미국, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
      • Woodbury, Minnesota, 미국, 55125
        • HealthEast Cancer Care at Woodwinds Health Campus
    • Nebraska
      • Lincoln, Nebraska, 미국, 68510
        • Cancer Resource Center - Lincoln
      • Omaha, Nebraska, 미국, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, 미국, 68122
        • Immanuel Medical Center
      • Omaha, Nebraska, 미국, 68124
        • Alegant Health Cancer Center at Bergan Mercy Medical Center
      • Omaha, Nebraska, 미국, 68131-2197
        • Creighton University Medical Center
    • North Carolina
      • Rutherfordton, North Carolina, 미국, 28139
        • Rutherford Hospital
    • North Dakota
      • Bismarck, North Dakota, 미국, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, 미국, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, 미국, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, 미국, 58502
        • St. Alexius Medical Center Cancer Center
      • Fargo, North Dakota, 미국, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, 미국, 58122
        • MeritCare Broadway
    • Ohio
      • Bowling Green, Ohio, 미국, 43402
        • Wood County Oncology Center
      • Dayton, Ohio, 미국, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, 미국, 45405
        • Grandview Hospital
      • Dayton, Ohio, 미국, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, 미국, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, 미국, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, 미국, 45429
        • CCOP - Dayton
      • Findlay, Ohio, 미국, 45840
        • Blanchard Valley Medical Associates
      • Fremont, Ohio, 미국, 43420
        • Fremont Memorial Hospital
      • Kettering, Ohio, 미국, 45429
        • Charles F. Kettering Memorial Hospital
      • Lima, Ohio, 미국, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, 미국, 43537
        • Northwest Ohio Oncology Center
      • Maumee, Ohio, 미국, 43537
        • St. Luke's Hospital
      • Middletown, Ohio, 미국, 45044
        • Middletown Regional Hospital
      • Oregon, Ohio, 미국, 43616
        • St. Charles Mercy Hospital
      • Oregon, Ohio, 미국, 43616
        • Toledo Clinic - Oregon
      • Sandusky, Ohio, 미국, 44870
        • Firelands Regional Medical Center
      • Sandusky, Ohio, 미국, 44870
        • North Coast Cancer Care, Incorporated
      • Sylvania, Ohio, 미국, 43560
        • Flower Hospital Cancer Center
      • Tiffin, Ohio, 미국, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, 미국, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, 미국, 43606
        • Toledo Hospital
      • Toledo, Ohio, 미국, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, 미국, 43617
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, 미국, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Troy, Ohio, 미국, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon, Ohio, 미국, 43567
        • Fulton County Health Center
      • Xenia, Ohio, 미국, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Oklahoma
      • Tulsa, Oklahoma, 미국, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, 미국, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
    • South Carolina
      • Anderson, South Carolina, 미국, 29621
        • AnMed Cancer Center
      • Spartanburg, South Carolina, 미국, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, 미국, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, 미국, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, 미국, 57105
        • Medical X-Ray Center, PC
      • Sioux Falls, South Dakota, 미국, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Virginia
      • Fredericksburg, Virginia, 미국, 22401
        • Hematology-Oncology Associates of Fredericksburg, Incorporated
    • Wisconsin
      • La Crosse, Wisconsin, 미국, 54601
        • Franciscan Skemp Healthcare - La Crosse Campus

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed diffuse large B-cell lymphoma

    • B-cell phenotype (CD20+) as determined by immunohistochemistry (IHC) or flow cytometry
    • Stage II, III, or IV disease
  • CD22+ tumor by IHC*

NOTE: *CD22 status may be determined after study enrollment

  • Measurable disease, defined as at least 1 lesion ≥ 1.5 cm by CT scan or physical exam
  • No relapsed or refractory non-Hodgkin's lymphoma
  • No history of transformed lymphoma

  • No CNS lymphoma

    • CNS symptoms or bone marrow or sinus involvement must have absence of CNS lymphoma confirmed by lumbar puncture

PATIENT CHARACTERISTICS:

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3

    - For patients with ECOG PS 3, the PS must be disease related

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Total bilirubin ≤ 2 mg/dL (if total bilirubin > 2 mg/dL, direct bilirubin should be within normal limits)
  • AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if there is liver involvement)
  • Creatinine ≤ 2 times ULN
  • Life expectancy ≥ 12 weeks
  • Negative pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 12 months after completion of study treatment
  • No active serious infection requiring antibiotics
  • No New York Heart Association class III or IV heart disease
  • No other primary malignancy within the past 5 years, except for squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or previously treated prostate cancer with a stable prostate-specific antigen
  • No known HIV positivity
  • No known hepatitis B or C infection
  • Ejection fraction ≥ 45% by MUGA or echocardiogram (required if patients has a history of heart disease or is ≥ 50 years old)
  • Willing to provide blood and tissue samples for mandatory translational research component of study

PRIOR CONCURRENT THERAPY:

  • No prior therapy for diffuse large B-cell lymphoma, including the following:

    • Chemotherapy
    • Immunotherapy
    • Biologic therapy
    • Radiotherapy
  • Prior short course (≤ 14 days) of corticosteroids allowed
  • Prior splenectomy allowed
  • No prior pelvic irradiation
  • No other concurrent investigational agents
  • No concurrent chemotherapy, immunotherapy, or radiotherapy
  • No concurrent enrollment on another treatment study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy)

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
실험적: Epratuzumab + Rituximab + CHOP
One arm open label.
의약품: 사이클로포스파마이드
의약품: 프레드니손
의약품: 빈크리스틴 설페이트
의약품: 독소루비신 염산염
생물학적: 리툭시맙
생물학적: 에프라투주맙

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Event-free Survival After 12 Months
기간: From Baseline to 12 months
The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).
From Baseline to 12 months

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival
기간: time from study entry to 36 months
Percentage of participants alive at different time points
time from study entry to 36 months
Progression-free Survival (PFS)
기간: the time from study entry to 36 months
Percentage of participants Progression-free at different time points. Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
the time from study entry to 36 months
Overall Response Rate (ORR)
기간: Baseline to first 6 cycles of treatment
Overall response rate will be estimated by the number of patients with objective status of partial response (PR), unconfirmed complete response (CRu), or complete response (CR) during the first 6 cycles of treatment divided by number of evaluable patients (met eligibility criteria, signed consent form, and started treatment). Response was assessed using International Workshop Response Criteria.38 Response is based on CT alone. Relapse or progression is defined as Enlarging liver/spleen, new sites, New or increased lymph nodes, New or Increased lymph node masses, bone marrow reappearance.
Baseline to first 6 cycles of treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Alliance for Clinical Trials in Oncology

협력자

National Cancer Institute (NCI)

수사관

  • 연구 의자: Ivana Micallef, MD, Mayo Clinic

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

유용한 링크

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

2006년 1월 1일

기본 완료 (실제)

2008년 10월 1일

연구 완료 (실제)

2015년 4월 1일

연구 등록 날짜

최초 제출

2006년 3월 9일

QC 기준을 충족하는 최초 제출

2006년 3월 9일

처음 게시됨 (추정)

2006년 3월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 10월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 10월 1일

마지막으로 확인됨

2019년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NCCTG-N0489
  • NCI-2012-02685 (레지스트리 식별자: CTRP (Clinical Trials Reporting System))
  • CDR0000459932 (레지스트리 식별자: PDQ (Physician Data Query))

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. .

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