Proton Beam Radiation Therapy in Treating Patients with Stage II or III Esophageal Cancer

Status: Active

Description

This phase II trial studies how well proton beam radiation therapy works in treating patients with stage II or III esophageal cancer. Proton beam radiation therapy uses high energy protons to kill tumor cells and shrink tumors while causing less damage to healthy tissues and organs.

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 positron emission tomography (PET)/computed tomography (CT) and esophagogastroduodenoscopy (EGD) or endoscopic ultrasound (EUS) OR CT with (w/) contrast and EGD to have stage II or III disease per American Joint Committee on Cancer (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
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • White blood cells (WBC) > 2,500/mcL
  • Platelets >= 75,000/mcl
  • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x IULN
  • Creatinine =< 1.5 x IULN OR creatinine clearance >= 50 mL/min/1.73 m^2 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 Institutional Review Board (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

Locations & Contacts

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Contact: Shahed Nicolas Badiyan
Phone: 314-273-2931
Email: shadiyan@wustl.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess patient-reported outcomes of proton beam therapy (PBT) for esophageal cancer at 6 months following chemoradiation.

II. To assess physician-reported toxicity of PBT for esophageal cancer.

III. To assess patient-reported outcomes of PBT for esophageal cancer at 12 months following chemoradiation.

SECONDARY OBJECTIVES:

I. To assess progression-free survival (PFS) of PBT for patients with resectable versus (vs.) unresectable esophageal cancer.

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

OUTLINE:

Patients undergo proton beam radiation therapy 5 days a week for up to 6 weeks. Beginning 8 to 10 weeks after completion of proton beam radiation therapy, patients undergo surgery.

After completion of study treatment, patients are followed up every 3-4 months for 2 years, then every 6 months for 3 years thereafter.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Siteman Cancer Center at Washington University

Principal Investigator
Shahed Nicolas Badiyan

Trial IDs

Primary ID 201803092
Secondary IDs NCI-2018-00754
Clinicaltrials.gov ID NCT03482791