- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03482791
Proton Beam Therapy in the Treatment of Esophageal Cancer
May 25, 2023 updated by: Washington University School of Medicine
A Phase II Study of Proton Beam Therapy in the Treatment of Esophageal Cancer
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1: Resectable (proton beam therapy)
|
Other Names:
-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
Other Names:
|
Experimental: Arm 2: Unresectable (proton beam therapy)
|
Other Names:
-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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to 6 months following end of chemoradiation in patient-reported outcomes of PBT for esophageal cancer as measured by the MDASI-Plus
Time Frame: 6 months following chemoradiation (estimated to be 9 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, ranking their symptoms on a 0 (no problems) to 10 (worst imaginable) scale before treatment, weekly during treatment, and in treatment follow-up.
|
6 months following chemoradiation (estimated to be 9 months)
|
Patient-reported outcomes of PBT for esophageal cancer as measured by the EQ-5D
Time Frame: 6 months following chemoradiation (estimated to be 9 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.
|
6 months following chemoradiation (estimated to be 9 months)
|
Patient-reported outcomes of PBT for esophageal cancer as measured by the SF-12
Time Frame: 6 months following chemoradiation (estimated to be 9 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.
|
6 months following chemoradiation (estimated to be 9 months)
|
Patient-reported outcomes of PBT for esophageal cancer as measured by the MOS Social Support
Time Frame: 6 months following chemoradiation (estimated to be 9 months)
|
The 19-item Medical Outcomes Study (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 with higher scores indicating a greater availability of social support.
|
6 months following chemoradiation (estimated to be 9 months)
|
Patient-reported outcomes of PBT for esophageal cancer as measured by the 4-Item CES-D
Time Frame: 6 months following chemoradiation (estimated to be 9 months)
|
The Center for Epidemiological Studies Depression Scale (CES-D) 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.
|
6 months following chemoradiation (estimated to be 9 months)
|
Patient-reported outcomes of PBT for esophageal cancer as measured by the 4-Item CES-D
Time Frame: 12 months following chemoradiation (estimated to be 15 months)
|
The Center for Epidemiological Studies Depression Scale (CES-D) 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.
|
12 months following chemoradiation (estimated to be 15 months)
|
Patient-reported outcomes of PBT for esophageal cancer as measured by the MOS Social
Time Frame: 12 months following chemoradiation (estimated to be 15 months)
|
The 19-item Medical Outcomes Study (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 with higher scores indicating a greater availability of social support.
|
12 months following chemoradiation (estimated to be 15 months)
|
Patient-reported outcomes of PBT for esophageal cancer as measured by the SF-12
Time Frame: 12 months following chemoradiation (estimated to be 15 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.
|
12 months following chemoradiation (estimated to be 15 months)
|
Patient-reported outcomes of PBT for esophageal cancer as measured by the EQ-5D
Time Frame: 12 months following chemoradiation (estimated to be 15 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.
|
12 months following chemoradiation (estimated to be 15 months)
|
Change in baseline to 12 months following end of chemoradiation in patient-reported outcomes of PBT for esophageal cancer as measured by the MDASI-Plus
Time Frame: 12 months following chemoradiation (estimated to be 15 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, ranking their symptoms on a 0 (no problems) to 10 (worst imaginable) scale before treatment, weekly during treatment, and in treatment follow-up.
|
12 months following chemoradiation (estimated to be 15 months)
|
Physician-reported toxicity of PBT for esophageal cancer
Time Frame: 6 months following chemoradiation (estimated to be 9 months)
|
-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
|
6 months following chemoradiation (estimated to be 9 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS) of proton beam therapy (PBT) for patients with resectable versus unresectable esophageal cancer
Time Frame: 2 years following chemoradiation (estimated to be 2 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.
|
2 years following chemoradiation (estimated to be 2 years and 3 months)
|
Overall survival (OS)of PBT for patients with resectable versus unresectable esophageal cancer
Time Frame: 2 years following chemoradiation (estimated to be 2 years and 3 months)
|
2 years following chemoradiation (estimated to be 2 years and 3 months)
|
|
Progression-free survival (PFS) of proton beam therapy (PBT) for patients with resectable
Time Frame: 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)
|
Overall survival (OS)of PBT for patients with resectable versus unresectable esophageal
Time Frame: 5 years following chemoradiation (estimated to be 5 years and 3 months)
|
5 years following chemoradiation (estimated to be 5 years and 3 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gregory Vlacich, M.D., Ph.D., Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 19, 2018
Primary Completion (Actual)
September 13, 2022
Study Completion (Estimated)
August 9, 2026
Study Registration Dates
First Submitted
March 15, 2018
First Submitted That Met QC Criteria
March 22, 2018
First Posted (Actual)
March 29, 2018
Study Record Updates
Last Update Posted (Actual)
May 30, 2023
Last Update Submitted That Met QC Criteria
May 25, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201803092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Esophageal Cancer
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OHSU Knight Cancer InstituteOregon Health and Science UniversityWithdrawnStage IIB Esophageal Cancer AJCC v7 | Stage III Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7
-
National Cancer Institute (NCI)NRG OncologyCompletedEsophageal Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Stage IIA Esophageal Cancer AJCC v7 | Stage IIB Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IB Esophageal Cancer AJCC v7United States
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University of Wisconsin, MadisonActive, not recruitingResectable Esophageal Cancer | GastroEsophageal CancerUnited States
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Cancer Institute and Hospital, Chinese Academy...Tianjin Medical University Cancer Institute and Hospital; Sichuan Cancer Hospital...UnknownEsophageal Neoplasm | Esophageal Cancer TNM Staging Primary Tumor (T) T3 | Esophageal Cancer TNM Staging Primary Tumor (T) T2 | Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0 | Esophageal Cancer TNM Staging Distal Metastasis (M) M0China
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Tianjin Medical University Cancer Institute and...Sun Yat-sen University; Cancer Institute and Hospital, Chinese Academy of Medical... and other collaboratorsNot yet recruitingStage III Esophageal Cancer | Stage II Esophageal Cancer
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Tianjin Medical University Cancer Institute and...UnknownStage III Esophageal Cancer | Stage II Esophageal CancerChina
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Academisch Medisch Centrum - Universiteit van Amsterdam...UMC UtrechtCompletedEsophageal Cancer, Stage II | Esophageal Cancer Stage IIINetherlands
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Tianjin Medical University Cancer Institute and...The First Affiliated Hospital with Nanjing Medical University; The First Affiliated... and other collaboratorsUnknownEsophageal Cancer Stage III | Esophageal Cancer Stage IIBChina
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedGastroesophageal Junction Adenocarcinoma | Stage IIA Esophageal Cancer AJCC v7 | Stage IIB Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7 | Malignant Neoplasm of the Cervical Esophagus | Malignant Neoplasm...United States
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-
National Cancer Center, KoreaCompletedProstate AdenocarcinomaKorea, Republic of
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University of WashingtonNational Cancer Institute (NCI)CompletedRecurrent Disease | Thoracic Neoplasm | Metastatic Malignant Neoplasm in the LungUnited States
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University College, LondonUniversity of Sheffield; Asthma + Lung UK; Mesothelioma UKRecruitingMalignant Pleural MesotheliomaUnited Kingdom
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