- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01752751
Predicting Tolerance to Radiation Therapy in Older Adults With Cancer
2018년 5월 31일 업데이트: UNC Lineberger Comprehensive Cancer Center
Predicting Tolerance to Radiation Therapy in Older Adults With Cancer: A Prospective Blinded Study of the Comprehensive Geriatric Assessment
A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict how older adults tolerate cancer treatments.
The investigators think this same tool (referred to as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance.
연구 개요
상세 설명
A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict for toxicity in older patients during cancer treatments.1 The investigators hypothesize that the same tool (referred to throughout this document as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance.
The primary objective of this study is to assess the association between pre-treatment functional status (as measured by the Independent Activities of Daily Living (I-ADL) components of the CGA) and poor tolerance to radiation therapy (as defined in section 2.3.1).
Secondary objectives include exploration of associations between pre-treatment I-ADL status on the CGA and the occurrence of any acute grade 3-5 toxicity from radiation therapy, or any decrease in Quality of Life (QoL) measures throughout radiation therapy as assessed by the EORTC QLQ-C30 questionnaire.
The investigators also want to compare the rate of physician reported acute toxicities to patient reported acute toxicities in an older cancer patient population, assess any association between elevated p16Ink4α expression in peripheral T lymphocytes and poor tolerance to or acute grade 3-5 toxicity from radiation therapy, and explore any association between other baseline components of the CGA and poor tolerance to or acute grade 3-5 toxicity from radiation therapy.
연구 유형
관찰
등록 (실제)
50
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- Radiation Oncology Clinic - UNC Cancer Hospital
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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
65년 이상 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Patients age ≥ 65 years of age, with one of the inclusion diagnoses, and an appointment for CT simulation for planning of radiation therapy at UNCH department of radiation oncology will be assessed for inclusion for this study.
설명
Inclusion Criteria:
- ≥Age 65 years (no upper age limit)
- Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
- Consented for receipt of External Beam Radiation Therapy (EBRT) at UNC Chapel Hill
- Able to read English (required for CGA)
- Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
- Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208)
Exclusion Criteria:
- ≥Age 65 years (no upper age limit)
- Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
- Consented for receipt of EBRT at UNC Chapel Hill
- Able to read English (required for CGA)
- Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
- Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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Cancer Patients Age 65 or above
Cancer patients age 65 years or above with a diagnosis of head and neck cancer or lung cancer with radiotherapy or chemoradiotherapy planned as part of curative standard treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and poor tolerance to radiation therapy
기간: 4-8 weeks post-radiation therapy
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To assess the association between pre-treatment loss of at least one independent activity of daily living (I-ADL) on the CGA and poor tolerance to radiation therapy
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4-8 weeks post-radiation therapy
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and the occurrence of any patient-reported toxicity from radiation therapy
기간: 4-8 weeks post-radiation therapy
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To assess the association between pre-treatment loss of at least one I-ADL on the CGA and the occurrence of any patient-reported acute grade 3-5 toxicity from radiation therapy
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4-8 weeks post-radiation therapy
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Association between pre-treatment loss of at least one independent activity of daily living and changes in Quality of Life measures
기간: 4-8 weeks post radiation therapy
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To assess the association between pre-treatment loss of at least one I-ADL on the CGA and changes in QoL measures, as evaluated by the EORTC-QLQ-C30 throughout radiation therapy
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4-8 weeks post radiation therapy
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Comparison of physician and patient-reported acute grade 3-5 toxicities
기간: 4-8 weeks post-radiation therapy
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To compare physician-reported acute grade 3-5 toxicities to patient-reported grade 3-5 acute toxicities in this older adult population.
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4-8 weeks post-radiation therapy
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Association between elevated p16Ink4α gene expression and poor tolerance to and/or physician/patient-reported toxicity from radiation therapy
기간: 4-8 weeks post-radiation therapy
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To assess the association between elevated p16Ink4α expression in peripheral T lymphocytes and poor tolerance to and/or patient reported and physician reported acute grade 3-5 toxicity from radiation therapy
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4-8 weeks post-radiation therapy
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Association between baseline components of the Comprehensive Geriatric Assessment and poor tolerance to or occurrence of patient-reported toxicity from radiation treatment
기간: 4-8 weeks post-radiation therapy
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To explore the association between baseline components of the CGA (other than I-ADL) and poor tolerance to or occurrence of any patient-reported acute grade 3-5 toxicity from radiation treatment.
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4-8 weeks post-radiation therapy
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Bhishamjit Chera, MD, Radiation Oncology UNC Cancer Hospital
- 연구 책임자: Noam VanderWalde, MD, Radiation Oncology UNC Cancer Hospital
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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)
2012년 11월 1일
기본 완료 (실제)
2015년 3월 1일
연구 완료 (실제)
2015년 3월 1일
연구 등록 날짜
최초 제출
2012년 12월 14일
QC 기준을 충족하는 최초 제출
2012년 12월 18일
처음 게시됨 (추정)
2012년 12월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 6월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 5월 31일
마지막으로 확인됨
2018년 5월 1일
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. .