Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT04682158
Phase
PHASE2
Status
Recruiting
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Conditions

  • Esophageal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Given IV
  • 3 Dimensional Conformal Radiation Therapy — RADIATION
    Undergo 3D CRT
  • Propranolol — DRUG
    Subject will be treated with 30 mg po BID Propranolol for up to 6 weeks
  • Intensity Modulated Radiation Therapy — RADIATION
    Undergo IMRT
  • Paclitaxel — DRUG
    Given IV

Study Details

This phase II trial studies the side effects and best dose of propranolol when administered concurrently with SOC neoadjuvant CRT in patients with esophageal carcinoma, with a safety lead-in and dose expansion cohort. Patients who are already on β-blockers will receive standard of care CRT, or definitive chemotherapy or chemotherapy-immunotherapy and will be considered separately as a single arm prospective cohort

Key Dates

Start date
Apr 1, 2021
Status verified
Dec 2025
Primary completion
Apr 1, 2029
Completion
Apr 1, 2029

Study Design

Enrollment
106 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Chemoradiation Therapy - Group I
    Patients receiving beta-blockers undergo radiation therapy in the form of IMRT or 3D CRT over 23-28 fractions for 5 days per week (Monday-Friday) for 5 weeks, and receive paclitaxel IV QW and carboplatin IV QW for 5 weeks in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Chemoradiation Therapy - Group II
    Patients undergo CRT as in Group I in the absence of disease progression or unacceptable toxicity.
  • Experimental: Chemoradiation Therapy plus Propanolol
    Patients undergo radiation therapy as in Group I. Patients receive propranolol PO BID for 4-8 weeks while receiving standard neoadjuvant/definitive chemotherapy or chemotherapy-immunotherapy or CRT in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Occurrence of Adverse Events [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263-

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By research site
Roswell Park Cancer Institute· Buffalo, NY

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