Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer
Phase 2 Study of Vertebral Augmentation and Radiotherapy in Painful or at Risk of Collapse Spinal Metastatic Cancer/Multiple Myeloma
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Arizona
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Tucson, Arizona, 미국, 85724
- University of Arizona
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of metastatic disease to the vertebra or multiple myeloma
- Negative pregnancy test within 2 weeks prior to registration
- Life expectancy of >= 3 months and Karnofsky performance status (KPS) score >= 40
- Pain scale score >=5
- Pain at involved vertebral body not adequately controlled
- Osteolysis of vertebral bodies
- Must agree to practice adequate means of birth control
- Must sign informed consent prior to study entry
- Must be able to understand the English language
- Absence of any serious cognitive or psychiatric problems potentially hampering compliance with the study and follow-up schedule.
Exclusion Criteria:
- Spinal Cord Compression
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: Vertebroplasty with Radiotherapy
Vertebroplasty with Radiotherapy is given in either order.
Radiotherapy dosage is at the discretion of the treating physician.
Vertebroplasty is applied to fractured vertebrae.
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Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.
다른 이름들:
Radiotherapy of metastatic lesions to the spine.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.
기간: 14 weeks
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Assessment of the patient's pain, activities and quality of life will be gathered from the patient in returning for follow-up or by contacting the patient by phone approximately 1 week following the completion of their first procedure, whether it be the vertebral augmentation or the radiotherapy (5 - 10 days following). Mandatory assessments include: - Worst Pain Score - Brief Pain Inventory (BPI) - The Worst Pain Assessment on the Brief Inventory Scale is an assessment tool of current pain intensity and pain intensity within the last 24 hours when not on pain control medications. 0 being no pain and 10 is the worst pain possible. See protocol attachments |
14 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS)
기간: 14 weeks
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Roland-Morris Disability Questionnaire - The score of the RDQ is the total number of items checked - i.e. from a minimum of 0 (best) to a maximum of 24 (worst). Karnofsky Performance Status (KPS) - scale from 10 (moribund, fatal processes progressing rapidly) to 100 (normal, no complaints, no evidence of disease). |
14 weeks
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Quality of Life Assessment From the EORTC QLQ C30 Questionnaire.
기간: 14 weeks
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EORTC QLQ-C30 (version 3) - The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning,a high score for the global health status / QoL represents a high QoL,but a high score for a symptom scale / item represents a high level of symptomatology / problems. |
14 weeks
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Fracture Rates Detected From X-rays.
기간: 14 weeks
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14 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Krisha Howell, MD, University of Arizona Radiation Oncology
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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. .
다발성 골수종에 대한 임상 시험
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University Hospital, Montpellier종료됨제1형 당뇨병 | Basal-bolus multiple-dily 인슐린 주사 | 인슐린 펌프(CSII)프랑스