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Trial record 2 of 15 for:    proton therapy | esophageal cancer

Proton Beam Therapy in the Treatment of Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT03482791
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Esophagus Cancer Esophageal Cancer Cancer of the Esophagus Radiation: Proton beam therapy Other: Patient-Reported Outcome Measures Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Proton Beam Therapy in the Treatment of Esophageal Cancer
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Radiation: 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.
Other Name: PBT

Other: Patient-Reported Outcome Measures
-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 2, 4, 6, 9, and 12-months following end of chemoradiation
Other Name: PROs

Experimental: 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
Radiation: 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.
Other Name: PBT

Other: Patient-Reported Outcome Measures
-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 2, 4, 6, 9, and 12-months following end of chemoradiation
Other Name: PROs




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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


Secondary Outcome Measures :
  1. Progression-free survival (PFS) of proton beam therapy (PBT) for patients with resectable versus unresectable esophageal cancer [ Time Frame: 2 years ]
    -PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

  2. Overall survival (OS)of PBT for patients with resectable versus unresectable esophageal cancer [ Time Frame: 2 years ]
  3. Progression-free survival (PFS) of proton beam therapy (PBT) for patients with resectable [ Time Frame: 5 years ]
    -PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

  4. Overall survival (OS)of PBT for patients with resectable versus unresectable esophageal [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482791


Contacts
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Contact: Shahed Badiyan, M.D. 314-273-2931 sbadiyan@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Shahed Badiyan, M.D.    314-273-2931    sbadiyan@wustl.edu   
Principal Investigator: Shahed Badiyan, M.D.         
Sub-Investigator: Cliff Robinson, M.D.         
Sub-Investigator: Hyun Kim, M.D.         
Sub-Investigator: Tianyu Zhao, Ph.D.         
Sub-Investigator: Haesong Park, M.D.         
Sub-Investigator: Bryan Meyers, M.D.         
Sub-Investigator: Beth Bottani, CMD         
Sub-Investigator: Michael Roach, M.D.         
Sub-Investigator: Jeffrey Bradley, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Shahed Badiyan, M.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03482791     History of Changes
Other Study ID Numbers: 201803092
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases