Proton Beam Therapy to Treat Esophageal Cancer

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Phase I Study of Proton Beam Therapy in the Treatment of Esophageal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02023541
• Other study ID #: 201310084
• Status: Terminated
• Phase: Phase 1
• First received: December 23, 2013
• Last updated: April 3, 2015
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma Of Esophagus
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Radiation:
• Proton beam therapy

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Patient-reported outcomes of PBT for esophageal cancer at 12 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).	1 year	No
Secondary	Quality of life	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).	6 months	No
Secondary	Toxicity	We will compare the proportion of =Grade 3 gastrointestinal or pulmonary toxicity events against historical controls utilizing Binomial tests for proportion.	1 year	Yes

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine