Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation in Colorectal Liver Metastases
Randomised Controlled Phase I/II Trail to Evaluate the Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation Therapy in Resectable Colorectal Liver Metastases Patients
The efficiency of T cell based immunotherapies is affected by the insufficient migration and activity of tumor specific effector T cells in the tumor. Aim of this phase I/II clinical trial is to evaluate whether a neoadjuvant, low dose radiotherapy can improve T cell connected anti tumor immune response in colorectal liver metastases.
The primary endpoint is the number of tumor infiltrating T cells. Furthermore the T cell activity in situ, the number of regulatory T cells and the frequency of tumor reactive T cells in the blood and bone marrow will be examined.
연구 개요
연구 유형
등록 (예상)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Heidelberg, 독일, 69120
- 모병
- University of Heidelberg
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연락하다:
- Juergen Weitz
- 전화번호: +49 6221 56 6250
- 이메일: juergen.weitz@med.uni-heidelberg.de
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연락하다:
- Christoph Reissfelder
- 전화번호: +49 6221 56 6250
- 이메일: christoph.reissfelder@med.uni-heidelberg.de
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
- Age ≥ 50 years
- Radiological urgently suspected colorectal liver metastasis
Exclusion Criteria:
- second malignancy
- Pregnancy and lactation
- no prior liver radiation
- liver metastasis must be resectable
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Radiation 0,5Gy
Radiation: one time Radiation with an intensity of 0.5 Gy Group A Beginning on a weekday 48 hours before surgery |
Radiation: one time Radiation with an intensity of 0.5 Gy Group A 2.0 Gy Group B 5 Gy Group C Beginning on a weekday 48 hours before surgery |
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활성 비교기: No radiation
Control group with 0Gy radiation
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Control group with 0Gy
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활성 비교기: Radiation 2Gy
Radiation: one time Radiation with an intensity of 2.0 Gy Group B Beginning on a weekday 48 hours before surgery |
Radiation: one time Radiation with an intensity of 0.5 Gy Group A 2.0 Gy Group B 5 Gy Group C Beginning on a weekday 48 hours before surgery |
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활성 비교기: Radiation 5Gy
Radiation: one time Radiation with an intensity of 5 Gy Group C Beginning on a weekday 48 hours before surgery |
Radiation: one time Radiation with an intensity of 0.5 Gy Group A 2.0 Gy Group B 5 Gy Group C Beginning on a weekday 48 hours before surgery |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximal number of tumor infiltrating T-cells. The total T-cell activity serves as primary surrogate parameters for anti- tumor activity
기간: 2 years
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2 years
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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To determine local control and recurrence patterns of colorectal liver metastases in a CT
기간: 2 years
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2 years
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To determine the progression-free survival in patients treated with low dose photon beam radiation therapy
기간: 2 years
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2 years
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• To determine the surgical morbidity in patients undergoing liver resection who received this protocol treatment
기간: 2 years
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2 years
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• To determine 30-day post-operative mortality after liver resection in patients who received this protocol treatment
기간: 2 years
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2 years
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• To determine the T-cell activity in the resected liver tissue
기간: 2 years
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2 years
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• To determine quality of life according to the EORTC QoL questionnaire after 6 months.
기간: 6 months
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6 months
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To determine the number of regulatory T-cells in the resected liver tissue
기간: 2 years
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2 years
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To determine the frequencies of tumor-reactive T-cells in the blood and bone marrow of the patients
기간: 2 years
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2 years
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To determine quality of life according to the EORTC QoL questionnaire after 12 months.
기간: 1 year
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1 year
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To determine the number of patients with adverse events as a measure of safety and tolerability according to CTCAE, Version 4.0 criteria
기간: 2 years
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2 years
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공동 작업자 및 조사자
간행물 및 유용한 링크
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
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