Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer (ES01)
2018년 12월 19일 업데이트: University of Florida
A Phase II Trial of Dose Escalated Proton Beam Therapy or Photon Therapy for Resectable and Unresectable Esophageal Cancer
This study will evaluate if proton beam therapy as part of chemoradiation results in a decrease in diffusion lung capacity of carbon monoxide (DLCO) compared to photon radiation therapy for esophageal carcinoma.
A secondary objective is to determine effects on cardiac function, quality of life, and compare acute and late toxicities.
연구 개요
상세 설명
Radiation Modality: Proton radiotherapy will be offered to all patients that meet trial eligibility. If patients decline proton radiotherapy or are otherwise unable to receive proton therapy they will be included in x-ray cohort (group 2).
Chemotherapy will be delivered at the discretion of the treating Medical Oncologist. Weekly carboplatin and paclitaxel at standard doses is preferred. It is recommended that the weekly chemotherapy regimen be continued throughout the course of radiotherapy. Chemotherapy should begin within 48 hours of beginning radiotherapy.
연구 유형
중재적
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Florida
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Jacksonville, Florida, 미국, 32206
- University of Florida Proton Therapy Institute
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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:
- Patient must be at least 18 years at the time of consent.
- Pathologically confirmed esophageal adenocarcinoma or squamous cell. carcinoma of the thoracic esophagus or esophagogastric junction.
- Patient's preliminary cancer stage, according to the AJCC 7th edition staging, must be cT1b-T4, N0-N3.
Exclusion Criteria:
- Patients with cervical esophageal carcinoma.
- Prior radiotherapy with fields overlapping the current esophageal cancer.
- Patients with cT1a disease.
- Patients with evidence of tracheoesophageal fistula must undergo bronchoscopy to exclude fistula.
- Patients with distant metastatic disease.
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: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Proton
Proton beam therapy of 59.4 Gy in 1.8 Gy fractions (50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy
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59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
다른 이름들:
Concurrent weekly chemotherapy at standard doses
다른 이름들:
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활성 비교기: Photon
Photon Radiation therapy of 59.4 Gy in 1.8Gy fractions ( 50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy
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Concurrent weekly chemotherapy at standard doses
다른 이름들:
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Compare the rate of a clinically significant reduction of DLCO (defined as a decrease of ≥ 10% from baseline) between protons and photons after preoperative or definitive chemoradiation
기간: Approximately 12 months after radiation therapy
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Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Compare quality of life
기간: Approximately 12 months after radiation therapy
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Participants quality of life results using EORTC Quality of Life Questionnaire - Oesophageal Cancer Module (OES-18) and EORTC QLQ C-30 conjointly approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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Compare outcomes for local control
기간: Approximately 12 months after radiation therapy
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Number of participants with local control for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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Compare outcomes for progression free survival
기간: Approximately 12 months after radiation therapy
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Number of participants with progression free survival for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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Compare overall survival rates
기간: Approximately 12 months after radiation therapy
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Number of participants with overall survival rates for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Michael Rutenberg, MD, PhD, UF Health Proton Therapy Institute
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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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)
2017년 10월 30일
기본 완료 (실제)
2018년 12월 11일
연구 완료 (실제)
2018년 12월 11일
연구 등록 날짜
최초 제출
2017년 7월 21일
QC 기준을 충족하는 최초 제출
2017년 7월 26일
처음 게시됨 (실제)
2017년 7월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 12월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 12월 19일
마지막으로 확인됨
2018년 12월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UFPTI 1605-ES01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
미국에서 제조되어 미국에서 수출되는 제품
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. .
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Jonsson Comprehensive Cancer Center종료됨거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Assiut University아직 모집하지 않음South Egypt Cancer Institute(SECI)에서 소아 악성종양 환자에 대한 KDIGO 기준을 사용하여 AKI의 누적 발병률을 확인하기 위해
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)모집하지 않고 적극적으로III기 전립선 선암종 AJCC v7 | II기 전립선 선암종 AJCC v7 | 1기 전립선 선암종 American Joint Committee on Cancer(AJCC) v7미국
Proton Beam Therapy에 대한 임상 시험
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Massachusetts General HospitalGenentech, Inc.모병
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University of ManitobaUniversity of Calgary; Tactica Interactive; Centre for Healthcare Innovation; Research Manitoba알려지지 않은
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University of CalgaryAlberta Children's Hospital; Provincial Health Services Authority; Brain Canada; MindSea Development 그리고 다른 협력자들모병
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University of ManitobaUniversity of Calgary; Tactica Interactive; Centre for Healthcare Innovation; Research Manitoba완전한
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Beam Therapeutics Inc.아직 모집하지 않음