NCT02023541

Brief Summary

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

December 23, 2013

Last Update Submit

April 3, 2015

Conditions

Esophageal Squamous Cell CarcinomaAdenocarcinoma Of Esophagus

Outcome Measures

Primary Outcomes (4)

  • Progression-free survival

    Assess progression-free survival (PFS) of PBT for patients with resectable vs. unresectable esophageal cancer. PFS will be assessed using the Kaplan-Meier estimate.

    5 years

  • Overall survival

    Assess overall survival (OS) of PBT for patients with resectable vs. unresectable esophageal cancer. OS will be assessed using the Kaplan-Meier estimate.

    5 years

  • Progression-free survival

    Assess progression-free survival (PFS) of PBT for patients with resectable vs. unresectable esophageal cancer. PFS will be assessed using the Kaplan-Meier estimate.

    2 years

  • Overall survival

    Assess overall survival (OS) of PBT for patients with resectable vs. unresectable esophageal cancer. OS will be assessed using the Kaplan-Meier estimate.

    2 years

Secondary Outcomes (3)

  • Patient-reported outcomes of PBT for esophageal cancer at 12 months following chemoradiation.

    1 year

  • Quality of life

    6 months

  • Toxicity

    1 year

Study Arms (2)

Resectable disease

OTHER

Patients with resectable disease will undergo treatment with proton beam therapy.

Radiation: Proton beam therapy

Unresectable disease

OTHER

Patients with unresectable disease will undergo treatment with proton beam therapy.

Radiation: Proton beam therapy

Interventions

Proton beam therapyRADIATION
Resectable diseaseUnresectable disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +2 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Esophageal Squamous Cell CarcinomaAdenocarcinoma Of Esophagus

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Study Officials

  • Jeffrey Bradley, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2013

First Posted

December 30, 2013

Study Start

January 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(1)