Pencil Beam Scanning Proton Radiotherapy for Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

An Observational Study of Pencil Beam Scanning (PBS) Proton Radiotherapy (RT) as a Component of Trimodality Therapy for Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452021
• Other study ID #: 15-002155
• Status: Completed
• Start date: July 2015
• Est. completion date: August 21, 2019

Study information

• Verified date: July 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective observational study designed to observe the toxicity and efficacy of PBS proton RT for patients with esophageal cancer undergoing trimodality therapy. The investigators hypothesize that PBS proton RT will be associated with a favorable adverse event profile and quality of life, with similar disease control outcomes, relative to historical comparisons of patients treated with photon RT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 21, 2019
• Est. primary completion date: May 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.
• Histological confirmation of adenocarcinoma or squamous cell carcinoma of the esophagus (mid, distal, or GE junction)
• Stage T1N1-3M0 or T2-4N0-3M0 by American Joint Commission on Cancer (AJCC) 7th edition
• Tumor extends = 5 cm into gastric cardia, based on EGD and PET/CT
• ECOG Performance Status (PS) 0-2 (Appendix I)
• Surgical consultation to confirm that patient is an appropriate candidate for esophagectomy
• Medical oncology consultation to confirm that patient is an appropriate candidate for chemotherapy
• Planned to receive standard of care neoadjuvant CRT, consisting of PBS proton RT (50 Gy/25 fractions) and concurrent chemotherapy (weekly carboplatin and paclitaxel), followed by surgical resection
• Ability to complete questionnaire(s) by themselves or with assistance.
• Provide informed written consent.
• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study). Note: During the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up.
• Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136

Exclusion Criteria:

• Cervical or upper esophageal tumors with any part of tumor < 24 cm from incisors
• Prior chemotherapy or RT for esophageal cancer
• History of RT to the thorax
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of adverse events.
• Immunocompromised patients and patients known to be HIV positive and not currently receiving antiretroviral therapy. NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.
• Other active malignancy = 1 year prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer.
• History of myocardial infarction =6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of CTCAE acute grade 3 or higher adverse effects possibly attributed to neoadjuvant CRT		Within 90 days of enrollment
Secondary	Surgical outcomes, including the percentage of patients who undergo a margin-negative (R0) resection and the rate of pathologic complete response (pCR)		Within 30 days following surgery
Secondary	Rate of postoperative complications		Within 30 days following surgery
Secondary	Length of hospital stay		Within 30 days following surgery
Secondary	Rate of CTCAE late grade 3 or higher adverse effects possibly attributed to therapy		24 months after enrollment
Secondary	Rate of local-regional recurrence (LRR), progression-free survival (PFS), and overall survival (OS)		24 months after enrollment
Secondary	Patient-reported quality of life using LASA-3, Mayo-10, PRO-CTCAE, and FACT-E		24 months after enrollment
Secondary	Assessment of early cardiac toxicity after CRT using cardiac MRI		42 days after completion of CRT

External Links

•   Mayo Clinic Clinical Trials