Clinical trial NCT03482791: Proton Beam Therapy in the Treatment of Esophageal Cancer
Official title: A Phase II Study of Proton Beam Therapy in the Treatment of Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Esophagus Cancer
Esophageal Cancer
Cancer of the Esophagus
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
measure: Physician-reported Toxicity of PBT for Esophageal Cancer
timeFrame: Through 6 months following chemoradiation (estimated to be 9 months)
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
measure: Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score
timeFrame: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Secondary outcomes:
measure: Progression-free Survival (PFS) of Proton Beam Therapy (PBT) for Patients With Resectable
timeFrame: 5 years following chemoradiation (estimated to be 5 years and 3 months)
measure: Overall Survival (OS)of PBT for Patients With Resectable Versus Unresectable Esophageal
timeFrame: 5 years following chemoradiation (estimated to be 5 years and 3 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Gregory Vlacich, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: