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Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

2011년 2월 26일 업데이트: American College of Radiology Imaging Network

Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma

RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's response to treatment and plan more effective treatment.

PURPOSE: This phase II trial is studying how well ^18FDG-PET imaging works in detecting disease progression and determining response to treatment in patients who are undergoing chemoradiotherapy for locally advanced non-small cell lung cancer.

연구 개요

상태

알려지지 않은

정황

개입 / 치료

상세 설명

OBJECTIVES:

Primary

  • Determine whether peak standardized uptake value (SUV) for fludeoxyglucose F 18 positron emission tomography (FDG-PET) shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer.

Secondary

  • Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients.
  • Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients.
  • Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients.
  • Correlate, if possible, Ki-67 expression with overall survival of patients assessed with these imaging techniques.

OUTLINE: This is a diagnostic, multicenter study.

Before starting chemoradiotherapy, patients undergo baseline whole-body positron emission tomography (PET) imaging. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed 50-70 minutes later by PET imaging. Patients then receive concurrent definitive radiotherapy and chemotherapy. Patients enrolled in other treatment-oriented clinical trials receive therapy as per that trial. Other patients receive standard thoracic radiotherapy (dose ≥ 60 Gy) and standard chemotherapy comprising a platin (cisplatin or carboplatin) and a second non-platin, non-gemcitabine drug (etoposide, vinblastine, vinorelbine, paclitaxel, or docetaxel). Approximately 14 weeks after completion of chemoradiotherapy and adjuvant chemotherapy (if given), patients undergo post-treatment ^18FDG-PET imaging.

Patients are followed every 3 months for 2 years and then every 6 months for at least 1 year.

PROJECTED ACCRUAL: A total of 250 patients (including at least 75 with stage IIB/IIIA disease and at least 75 with stage IIIB disease) will be accrued for this study within 2 years.

연구 유형

중재적

등록 (예상)

250

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 대한민국
      • Goyang, 대한민국, 410-769
        • National Cancer Center - Korea
  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35294
        • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
    • Arizona
      • Scottsdale, Arizona, 미국, 85262
        • Scottsdale Medical Imaging, Limited
    • California
      • Los Angeles, California, 미국, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Sacramento, California, 미국, 95816
        • Radiological Associates of Sacramento Medical Group at Sutter Cancer Center
    • Connecticut
      • New Haven, Connecticut, 미국, 06511
        • Hospital of Saint Raphael
    • Florida
      • Boynton Beach, Florida, 미국, 33435
        • Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital
      • Dearfield Beach, Florida, 미국, 33064-3596
        • North Broward Medical Center
      • Jacksonville, Florida, 미국, 32207
        • Integrated Community Oncology Network at Baptist Cancer Institute
      • Tallahassee, Florida, 미국, 32308
        • Tallahassee Memorial Hospital
    • Illinois
      • Chicago, Illinois, 미국, 60612
        • Rush Cancer Institute at Rush University Medical Center
    • Indiana
      • Anderson, Indiana, 미국, 46016
        • Saint John's Cancer Center at Saint John's Medical Center
      • Goshen, Indiana, 미국, 46526
        • Center for Cancer Care at Goshen General Hospital
      • South Bend, Indiana, 미국, 46601
        • CCOP - Northern Indiana CR Consortium
    • Maryland
      • Baltimore, Maryland, 미국, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, 미국, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, 미국, 02129
        • Dana-Farber Partners Cancer Care
      • South Weymouth, Massachusetts, 미국, 02190
        • South Shore Hospital
    • Michigan
      • Detroit, Michigan, 미국, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Kalamazoo, Michigan, 미국, 49007-3731
        • West Michigan Cancer Center
      • Royal Oak, Michigan, 미국, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • Missouri
      • St. Louis, Missouri, 미국, 63110
        • Mallinckrodt Institute of Radiology at Washington University Medical Center
    • Nevada
      • Reno, Nevada, 미국, 89502
        • Renown Institute for Cancer at Renown Regional Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, 미국, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Teaneck, New Jersey, 미국, 07666
        • Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
      • Toms River, New Jersey, 미국, 08755
        • J. Phillip Citta Regional Cancer Center at Community Medical Center
    • Ohio
      • Akron, Ohio, 미국, 44302
        • McDowell Cancer Center at Akron General Medical Center
      • Cleveland, Ohio, 미국, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, 미국, 44111
        • Cleveland Clinic Cancer Center at Fairview Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73104
        • Oklahoma University Cancer Institute
    • Oregon
      • Portland, Oregon, 미국, 97239-3098
        • Knight Cancer Institute at Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, 미국, 19141
        • Albert Einstein Cancer Center
      • Philadelphia, Pennsylvania, 미국, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, 미국, 15232
        • UPMC Cancer Centers
      • Wynnewood, Pennsylvania, 미국, 19096
        • Lankenau Cancer Center at Lankenau Hospital
    • Rhode Island
      • Providence, Rhode Island, 미국, 02908-4735
        • Roger Williams Medical Center
      • Providence, Rhode Island, 미국, 02912
        • Brown University School of Medicine
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Spartanburg, South Carolina, 미국, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Tennessee
      • Nashville, Tennessee, 미국, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Dallas, Texas, 미국, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Houston, Texas, 미국, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
    • Utah
      • Salt Lake City, Utah, 미국, 84112
        • Huntsman Cancer Institute at University of Utah
    • Virginia
      • Richmond, Virginia, 미국, 23226
        • Bon Secours Cancer Institute at St. Mary's Hospital
    • Wisconsin
      • Madison, Wisconsin, 미국, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
      • Waukesha, Wisconsin, 미국, 53188
        • Waukesha Memorial Hospital Regional Cancer Center
  • 캐나다
    • Alberta
      • Calgary, Alberta, 캐나다, T2N 4N2
        • Tom Baker Cancer Centre - Calgary
    • Ontario
      • Kitchner, Ontario, 캐나다, N2G 1G3
        • Grand River Regional Cancer Centre at Grand River Hospital

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 non-small cell lung cancer (NSCLC)

    • Clinical stage IIB or III disease
    • No small cell carcinoma
    • No stage IV disease*
    • No diffuse bronchoalveolar subtype
    • No planned definitive surgical resection NOTE: *Patients with evidence of stage IV disease by positron emission tomography are eligible if the evidence cannot be confirmed by other means AND the physician still plans to proceed with definitive chemoradiation

  • Planning treatment with definitive chemoradiotherapy

    • May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy
    • Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy
  • No brain metastases by head CT scan or MRI

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy)
  • Able to tolerate positron emission tomography imaging
  • No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL)
  • No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy

Chemotherapy

  • See Disease Characteristics
  • No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior thoracic radiotherapy
  • No concurrent intensity-modulated radiotherapy

Surgery

  • See Disease Characteristics

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 특수 증상
  • 마스킹: 없음(오픈 라벨)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution

2차 결과 측정

결과 측정
Relationship of survival to post-treatment max SUV as determined by the imaging institute
Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution
Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution
Reliability between peak and max SUV measurements both pre- and post-treatment
Proportion of participants who are either upstaged or downstaged by positron emission tomography scan
Reliability between PET scan-defined response to therapy measurements
Correlation of Ki-67 expression with peak and max pre-treatment SUV
Association between Ki-67 expression and overall survival at 2 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

American College of Radiology Imaging Network

협력자

National Cancer Institute (NCI)
Radiation Therapy Oncology Group

수사관

  • 연구 의자: Mitchell Machtay, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

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

2005년 3월 1일

기본 완료 (예상)

2006년 6월 1일

연구 등록 날짜

최초 제출

2004년 5월 14일

QC 기준을 충족하는 최초 제출

2004년 5월 14일

처음 게시됨 (추정)

2004년 5월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2011년 3월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2011년 2월 26일

마지막으로 확인됨

2007년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CDR0000362061
  • ACRIN-6668
  • RTOG-0235

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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약물 개입

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위치

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