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Proton Beam Therapy to Treat Esophageal Cancer

This study has been terminated.
(Lack of insurance coverage for proton beam treatment)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02023541
First received: December 23, 2013
Last updated: April 3, 2015
Last verified: April 2015
  Purpose
Assess progression-free survival and overall survival of proton beam therapy (PBT) for patients with resectable vs. unresectable esophageal cancer, and to assess patient-reported outcomes of PBT for esophageal cancer at 6 months following chemoradiation and physician-reported toxicity of PBT for esophageal cancer.

Condition Intervention Phase
Esophageal Squamous Cell Carcinoma
Adenocarcinoma Of Esophagus
Radiation: Proton beam therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Proton Beam Therapy in the Treatment of Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 5 years ]

    Assess progression-free survival (PFS) of PBT for patients with resectable vs. unresectable esophageal cancer.

    PFS will be assessed using the Kaplan-Meier estimate.


  • Overall survival [ Time Frame: 5 years ]

    Assess overall survival (OS) of PBT for patients with resectable vs. unresectable esophageal cancer.

    OS will be assessed using the Kaplan-Meier estimate.


  • Progression-free survival [ Time Frame: 2 years ]

    Assess progression-free survival (PFS) of PBT for patients with resectable vs. unresectable esophageal cancer.

    PFS will be assessed using the Kaplan-Meier estimate.


  • Overall survival [ Time Frame: 2 years ]

    Assess overall survival (OS) of PBT for patients with resectable vs. unresectable esophageal cancer.

    OS will be assessed using the Kaplan-Meier estimate.



Secondary Outcome Measures:
  • Patient-reported outcomes of PBT for esophageal cancer at 12 months following chemoradiation. [ Time Frame: 1 year ]
    We will calculate descriptive statistics (mean, standard deviation, etc.) for all QOL data (EQ-5D, SF-12) in addition to other PROs (depressive symptoms, social support) at each evaluation period. Univariate tests will explore the associations among QOL and PROs using analysis of variance (ANOVA) and Fisher's exact test for correlation. Changes over time in QOL and PROs will be analyzed utilizing repeated-measures modeling techniques (repeated measures analysis of covariance).

  • Quality of life [ Time Frame: 6 months ]

    Patient-reported outcomes of proton beam therapy (PBT) for esophageal cancer at 6 months following chemoradiation

    We will calculate descriptive statistics (mean, standard deviation, etc.) for all QOL data (EQ-5D, SF-12) in addition to other PROs (depressive symptoms, social support) at each evaluation period. Univariate tests will explore the associations among QOL and PROs using analysis of variance (ANOVA) and Fisher's exact test for correlation. Changes over time in QOL and PROs will be analyzed utilizing repeated-measures modeling techniques (repeated measures analysis of covariance).


  • Toxicity [ Time Frame: 1 year ]
    We will compare the proportion of ≥Grade 3 gastrointestinal or pulmonary toxicity events against historical controls utilizing Binomial tests for proportion.


Enrollment: 3
Study Start Date: January 2014
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Resectable disease
Patients with resectable disease will undergo treatment with proton beam therapy.
Radiation: Proton beam therapy
Unresectable disease
Patients with unresectable disease will undergo treatment with proton beam therapy.
Radiation: Proton beam therapy

  Eligibility

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

Inclusion Criteria:

  • Histologically 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 CT w/contrast and EGD to have stage II or III disease. Endoscopic ultrasound (EUS) is encouraged but not required.
  • Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II or III esophageal cancer 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 (Karnofsky > 60%)
  • Normal bone marrow and organ function as defined below:

    • WBC > 2,500/mcL
    • Platelets ≥ 75,000/mcl
    • Total bilirubin ≤ 1.5 x 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 study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02023541

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jeffrey Bradley, M.D. Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02023541     History of Changes
Other Study ID Numbers: 201310084 
Study First Received: December 23, 2013
Last Updated: April 3, 2015

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on February 20, 2017