Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
A Study of Dose Escalation of Hypofractionated Radiation Therapy in Patients With Metastatic Cancer
Patients with metastatic cancer are generally treated with chemotherapy, which has improved median survival compared to best supportive care. Despite this, patients continue to have persistent disease at sites that were initially involved with cancer. Radiation therapy is an effective modality for treating localized cancer but generally has been only used for palliation of symptoms once a patient develops metastatic disease. Since patients often have persistent disease after chemotherapy, the goal of this trial is to use increasing doses of radiation therapy to all sites of involved disease in order to determine the safety and efficacy of hypofractionated radiation therapy.
The purpose of this study is to establish a maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose of hypofractionated radiation therapy.
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60637
- University of Chicago
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of cancer (including epithelial carcinoma, sarcoma, and melanoma)
- Age 18 years and older
- Life expectancy of > 3 months
- Patients with AJCC (6th edition, 2002) stage IV cancer with distant metastases and without pleural or pericardial effusion at diagnosis and before start of study
- Patients with 1-5 sites of maximum tumor dimension (for each individual site) of ≤ 10 cm or < 500 cc volume and amenable to radiation therapy as seen on standard imaging
- Unidimensionally measurable disease (based on RECIST) is desirable but not strictly required
- Brain metastases must have been treated prior to enrollment on study, preferably with stereotactic radiosurgery
- ECOG performance status ≤ 2 or Karnofsky Performance Status ≥ 60%
- No prior radiation therapy to currently involved tumor sites
- Room air saturation > 90%
- Hemoglobin > 9.0 g/dl
- ANC >=1,500/microliter
- Platelets >=100,000/microliter
- Total bilirubin within institutional limits
- Albumin > 2.9 g/dl
- Alkaline phosphatase < 2.5x upper limit of normal
- AST and ALT < 2.5 x upper limit of normal
- Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
- Uncontrolled intercurrent illness
- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. Exclusion of patients with active coronary heart disease will be at the discretion of the attending physician
- Patients with significant atelectasis such that CT definition of gross tumor volume is difficult to determine
- Pregnancy or breast feeding
- Patients must have no uncontrolled active infection other than that not curable with treatment of their cancer.
- Patients may not be receiving any other investigational drugs during RT
공부 계획
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 |
|---|---|
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실험적: 방사선 요법
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RT to site of metastatic disease for three fractions separated by 3 to 8 days. Doses of radiation will increase as follows in order to determine the MTD in Gy: For all sites the dose levels are as follows:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dose-limiting toxicities
기간: 30-90 days
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The dose limiting toxicities occurring within the initial observation period will be defined.
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30-90 days
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maximum tolerated dose of hypofractionated RT
기간: 30-90 days
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30-90 days
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .