- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01927978
Using "PET Response Criteria in Solid Tumors (PERCIST)" in Evaluating Response to Neoadjuvant Chemoradiotherpy for Esophageal Cancer
This study is aimed to evaluate the effectiveness of 18F-FDG PET in the initial staging, therapy planning, and therapeutic response monitoring for esophageal cancer patients.
Purpose:
- The incremental staging information by using 18F-FDG PET
- The impact of the PET results on the patients' subsequent therapy planning
- To compare treatment response using RECIST criteria and FDG PET results.
연구 개요
상태
정황
상세 설명
Background: Esophageal cancer is one of the leading malignancies in Taiwan. Accuracy tumor staging can direct to appropriate therapy planning and provide prognostic implications. Positron emission tomography (PET) with [18F]-fluoro-2-deoxy-D-glucose (FDG) has been shown to have better N staging and prognostic stratification abilities than conventional imaging modalities, such as endoscopic ultrasonography (EUS) and CT.
Purpose: This study is aimed to evaluate the effectiveness of 18F-FDG PET in the initial staging, therapy planning, and therapeutic response monitoring for esophageal cancer patients.
Method: Patients with pathological proven esophageal cancer, age 20-90 year-old, will be included in this study. Each patient will receive a baseline PET study. For those patients who received pre-operative CCRT, another PET will be performed 1-4 weeks after completion of CCRT.
Primary outcome: 1. The incremental staging information by using 18F-FDG PET 2. The impact of the PET results on the patients' subsequent therapy planning 3. To compare treatment response using RECIST criteria and FDG PET results.
Secondary outcome: To correlate the PET response rate and the patients' disease free survival and overall survival.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Taipei, 대만, 100
- 모병
- National Taiwan University Hospital
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연락하다:
- Yen Ruoh Fang, M.D., Ph.D.
- 전화번호: 65581 886-2-23123456
- 이메일: rfyen@ntu.edu.tw
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수석 연구원:
- Yen Ruoh Fang, M.D., Ph.D.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age:20-90 years old
- Histological proved esophageal cancer
- ECOG performance status 0-2
- written informed consent signed
Exclusion Criteria:
- prior chemotherapy or treatment for other systemic anti-cancer agent(s)
- pregnant or intend to be pregnant
- other malignancies known
- other concurrent cancer treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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esophageal cancer, 18F-FDG PET
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
The effectiveness of 18F-FDG PET in the initial staging, therapy planning, and therapeutic response monitoring for esophageal cancer patients.
기간: 2 hours
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2 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: Yen Ruoh Fang, M.D.,Ph.D., National Taiwan University Hospital
간행물 및 유용한 링크
일반 간행물
- Yen TJ, Chung CS, Wu YW, Yen RF, Cheng MF, Lee JM, Hsu CH, Chang YL, Wang HP. Comparative study between endoscopic ultrasonography and positron emission tomography-computed tomography in staging patients with esophageal squamous cell carcinoma. Dis Esophagus. 2012 Jan;25(1):40-7. doi: 10.1111/j.1442-2050.2011.01204.x. Epub 2011 May 19.
- Enzinger PC, Mayer RJ. Esophageal cancer. N Engl J Med. 2003 Dec 4;349(23):2241-52. doi: 10.1056/NEJMra035010. No abstract available.
- Ng T, Vezeridis MP. Advances in the surgical treatment of esophageal cancer. J Surg Oncol. 2010 Jun 15;101(8):725-9. doi: 10.1002/jso.21566.
- Chatterton BE, Ho Shon I, Baldey A, Lenzo N, Patrikeos A, Kelley B, Wong D, Ramshaw JE, Scott AM. Positron emission tomography changes management and prognostic stratification in patients with oesophageal cancer: results of a multicentre prospective study. Eur J Nucl Med Mol Imaging. 2009 Mar;36(3):354-61. doi: 10.1007/s00259-008-0959-y. Epub 2008 Oct 18.
- Barber TW, Duong CP, Leong T, Bressel M, Drummond EG, Hicks RJ. 18F-FDG PET/CT has a high impact on patient management and provides powerful prognostic stratification in the primary staging of esophageal cancer: a prospective study with mature survival data. J Nucl Med. 2012 Jun;53(6):864-71. doi: 10.2967/jnumed.111.101568. Epub 2012 May 11.
- Yanagawa M, Tatsumi M, Miyata H, Morii E, Tomiyama N, Watabe T, Isohashi K, Kato H, Shimosegawa E, Yamasaki M, Mori M, Doki Y, Hatazawa J. Evaluation of response to neoadjuvant chemotherapy for esophageal cancer: PET response criteria in solid tumors versus response evaluation criteria in solid tumors. J Nucl Med. 2012 Jun;53(6):872-80. doi: 10.2967/jnumed.111.098699. Epub 2012 May 11.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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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