Predicting Tolerance to Radiation Therapy in Older Adults With Cancer
2018年5月31日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (実際)
50
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- Radiation Oncology Clinic - UNC Cancer Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
65年歳以上 (高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Bhishamjit Chera, MD、Radiation Oncology UNC Cancer Hospital
- スタディディレクター：Noam VanderWalde, MD、Radiation Oncology UNC Cancer Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2012年11月1日
一次修了 (実際)
2015年3月1日
研究の完了 (実際)
2015年3月1日
試験登録日
最初に提出
2012年12月14日
QC基準を満たした最初の提出物
2012年12月18日
最初の投稿 (見積もり)
2012年12月19日
学習記録の更新
投稿された最後の更新 (実際)
2018年6月4日
QC基準を満たした最後の更新が送信されました
2018年5月31日
最終確認日
2018年5月1日
詳しくは
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