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食道がん治療における陽子線治療

2026年9月10日 更新者：Washington University School of Medicine

食道がん治療における陽子線治療の第II相試験

The investigators plan to include both operable and inoperable patients with esophagus cancer in this prospective trial. Since both proton and photon treatments are biologically equivalent, the investigators do not expect a difference in tumor control compared to intensity modulated radiation therapy (IMRT). The investigators have a prospective experience of physician-reported toxicity and patient outcome using IMRT for patients with inoperable esophagus cancer that will serve as a comparison group. For the resectable patients receiving trimodality therapy (chemoradiation followed by surgery), the investigators will carefully track toxicity and patient outcomes prospectively. The central hypothesis is that the biologic efficacy for tumor control should be similar between protons and photons, and therefore survival measures should be similar between the two groups, but that the main difference lies in the total severe toxicities experienced by the patients undergoing therapy.

調査の概要

状態

終了しました

条件

介入・治療

研究の種類

介入

入学 (実際)

22

段階

  • 適用できない

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

  • アメリカ
    • Missouri
      • St Louis、Missouri、アメリカ、63110
        • Washington University School of Medicine

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

18年歳以上 (大人、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

説明

Inclusion Criteria:

  • Histologically or cytologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.

  • Staged by PET/CT and esophagogastroduodenoscopy (EGD) or endoscopic ultrasound (EUS) OR CT w/contrast and EGD to have stage II or III disease per AJCC 7th edition guidelines

  • Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II or III esophageal cancer (AJCC 7th edition) is eligible, irrespective of margin status.

  • Induction chemotherapy prior to concurrent chemoradiation is allowed.

  • Prior thoracic radiation is allowable if degree of overlap with the esophageal radiotherapy treatment is deemed to be safe by the treating radiation oncologist.

  • At least 18 years of age.

  • ECOG performance status < 2

  • Normal bone marrow and organ function as defined below:

    • WBC > 2,500/mcL
    • Platelets > 75,000/mcl
    • Total bilirubin < 1.5 x institutional upper limit of normal (IULN)
    • AST(SGOT)/ALT(SGPT) < 3.0 x IULN
    • Creatinine < 1.5 x IULN OR Creatinine clearance > 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

  • Ability to understand and willingness to sign an IRB approved written informed consent document.

  • English speaker.

  • Financial coverage for proton therapy.

Exclusion Criteria:

  • Planned treatment with radiation therapy alone without concurrent chemotherapy or chemotherapy alone.
  • Previous or concomitant cancers within the past 3 years other than curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, curative treatment for transitional cell carcinoma of the bladder, and low risk prostate cancer. Except for prostate cancer (which can be observed if low risk), other cancers listed must have been treated in the past 3 years without evidence of recurrence at the time of registration.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia not controlled by pacer device, myocardial infarction within 3 months of registration, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 7 days of the start of treatment.

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

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Arm 1: Resectable (proton beam therapy)
  • Proton beam therapy: total dose of 50 or 50.4 Gy
  • Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision
  • Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation
  • Patient-reported outcome measures (PROs) performed at several time points
放射線：Proton beam therapy
  • The daily prescription dose will be 1.8 or 2 Gy RBE ("Relative Biologic Equivalence") to be delivered to the periphery of the planning target volume (PTV).
  • The Mevion S-250 Proton Radiation Beam Therapy System will be used.
他の名前：
  • PBT
他の：Patient-Reported Outcome Measures

-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 8 weeks, 4, 6, 9, and 12-months following end of chemoradiation

他の名前：
  • PRO
実験的：Arm 2: Unresectable (proton beam therapy)
  • Proton beam therapy: total dose of 59.4 or 60 Gy
  • Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision
  • Patient-reported outcome measures (PROs) performed at several time points
放射線：Proton beam therapy
  • The daily prescription dose will be 1.8 or 2 Gy RBE ("Relative Biologic Equivalence") to be delivered to the periphery of the planning target volume (PTV).
  • The Mevion S-250 Proton Radiation Beam Therapy System will be used.
他の名前：
  • PBT
他の：Patient-Reported Outcome Measures

-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 8 weeks, 4, 6, 9, and 12-months following end of chemoradiation

他の名前：
  • PRO

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
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

The MDASI-Plus is a reliable, validated tool for assessing cancer-related symptoms regardless of therapy or specific cancer diagnosis. Patients are asked to fill out a twenty-seven question inventory. 21 questions ask the patient about the severity of their symptoms with answers ranging from 0=not present to 10=as bad as you can imagine. 6 questions ask the patient about how their symptoms interfered with their life with answers ranging from 0=did not interfere to 10=interfered completely. The higher the score the more severe symptom experience the patient experienced.
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

The EQ-5D is a standardized 2-part, patient-administered instrument used for direct and indirect assessment of health state utilities. The first part asks respondents to "check the ONE box [next to the appropriate statement] that best describes your health TODAY" for each of 5 health dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state. Both the 5-item index score and the VAS score are transformed into a utility score between 0 "Worst health state" and 1 "Best health state. The higher the score the better health a patient experienced.
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

The 19-item MOS Social Support Survey was designed for use with patients with chronic diseases and measures how often different kinds of support are available, if needed. Response choices range from "none of the time" (1) to "all of the time" (5). A mean social support score for all 19 items is computed to a 0-100 scale with higher scores indicating a greater availability of social support.
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

The CES-D questionnaire is a 20-item measure which evaluates depressive symptoms. This trial will make use of the validated 4-item screening version in order to reduce participant burden. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology.
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The MDASI-Plus is a reliable, validated tool for assessing cancer-related symptoms regardless of therapy or specific cancer diagnosis. Patients are asked to fill out a twenty-seven question inventory. 21 questions ask the patient about the severity of their symptoms with answers ranging from 0=not present to 10=as bad as you can imagine. 6 questions ask the patient about how their symptoms interfered with their life with answers ranging from 0=did not interfere to 10=interfered completely. The higher the score the more severe symptom experience the patient experienced.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The EQ-5D is a standardized 2-part, patient-administered instrument used for direct and indirect assessment of health state utilities. The first part asks respondents to "check the ONE box [next to the appropriate statement] that best describes your health TODAY" for each of 5 health dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state. Both the 5-item index score and the VAS score are transformed into a utility score between 0 "Worst health state" and 1 "Best health state. The higher the score the better health a patient experienced.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The 19-item MOS Social Support Survey was designed for use with patients with chronic diseases and measures how often different kinds of support are available, if needed. Response choices range from "none of the time" (1) to "all of the time" (5). A mean social support score for all 19 items is computed to a 0-100 scale with higher scores indicating a greater availability of social support.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The CES-D questionnaire is a 20-item measure which evaluates depressive symptoms. This trial will make use of the validated 4-item screening version in order to reduce participant burden. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Physician-reported Toxicity of PBT for Esophageal Cancer
時間枠：Through 6 months following chemoradiation (estimated to be 9 months)

Number of participants with grade 3 or higher specific cardiac, metabolism/nutrition, gastrointestinal, respiratory/thoracic/mediastinal, and skin/subcutaneous toxicity using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 related to PBT
Through 6 months following chemoradiation (estimated to be 9 months)
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life.

MCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. MCS range is 40-65.
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life.

PCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. PCS range is 30-55.
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life.

PCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. PCS range is 30-55.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life.

MCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. MCS range is 40-65.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-3.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-2.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-2.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-6.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-6.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score
時間枠：Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
回復可能な患者および切除不可能な食道の患者に対するPBTの全生存（OS）
時間枠：化学放射線の5年後（5年3か月と推定）
化学放射線の5年後（5年3か月と推定）
Progression-free Survival (PFS) of Proton Beam Therapy (PBT) for Patients With Resectable
時間枠：5 years following chemoradiation (estimated to be 5 years and 3 months)

-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
5 years following chemoradiation (estimated to be 5 years and 3 months)

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。

スポンサー

Washington University School of Medicine

捜査官

  • 主任研究者：Gregory Vlacich, M.D., Ph.D.、Washington University School of Medicine

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。

便利なリンク

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)

2018年4月19日

一次修了 (実際)

2022年9月13日

研究の完了 (実際)

2026年9月9日

試験登録日

最初に提出

2018年3月15日

QC基準を満たした最初の提出物

2018年3月22日

最初の投稿 (実際)

2018年3月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月2日

QC基準を満たした最後の更新が送信されました

2026年9月10日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 201803092

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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