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Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma

Primary Purpose

Esophageal Adenocarcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
3 Dimensional Conformal Radiation Therapy
Propranolol
Intensity Modulated Radiation Therapy
Paclitaxel
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Undergoing definitive or neoadjuvant CRT for histologically confirmed esophageal adenocarcinoma
  • Have an ECOG performance status of 0-1
  • Have the ability to swallow and retain oral medication. If a patient is not able to swallow, they are still eligible for study provided they have an enteric feeding placed which will permit administration of liquid formula propranolol prior to first radiation treatment
  • Participants of child-bearing potential must have a negative pregnancy test at study entry And then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. - Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

Exclusion Criteria:

  • Contraindications to the use of beta-blockers, e.g.; uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New York Heart Association (NYHA) Grade III or IV), hypotension ( systolic blood pressure <100 mmHg), severe asthma or COPD, uncontrolled type I or type II diabetes mellitus (HbA1C >8.5 or fasting plasma glucose > 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,symptomatic congestive heart failure, unstable angina pectoris, psychiatric illness/social situations that would limit compliance with study requirements, cardiac arrhythmia (atrial fibrillation/flutter), severe bradycardia (heart rate of <50 beats per minute or 1st/ 2nd /3rd degree heart block)
  • Pregnant or nursing female participants,
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug

Sites / Locations

  • Roswell Park Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Chemoradiation Therapy - Group I

Chemoradiation Therapy - Group II

Chemoradiation Therapy plus Propanolol

Arm Description

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.

Patients undergo CRT as in Group I in the absence of disease progression or unacceptable toxicity.

Patients undergo radiation therapy as in Group I. Patients receive propranolol PO BID for 4-6 weeks while receiving CRT in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Occurrence of Adverse Events
To determine the safety and efficacy of the combination of propranolol plus chemoradiation
Progression Free Survival
Imaging findings from first radiation treatment to progression of disease

Secondary Outcome Measures

Overall Survival
will be assessed by chart review of date of last follow-up or date of death

Full Information

First Posted
December 21, 2020
Last Updated
June 2, 2023
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04682158
Brief Title
Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma
Official Title
Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 and will be considered separately as a single arm prospective cohort
Detailed Description
PRIMARY OBJECTIVE: I. To determine the safety and efficacy of propranolol hydrochloride (propranolol) in combination with standard neoadjuvant/definitive chemoradiation therapy (CRT) for esophageal cancer. SECONDARY OBJECTIVE: I. To estimate overall survival (OS) and pathologic response rate in patients that undergo surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemoradiation Therapy - Group I
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Chemoradiation Therapy - Group II
Arm Type
Active Comparator
Arm Description
Patients undergo CRT as in Group I in the absence of disease progression or unacceptable toxicity.
Arm Title
Chemoradiation Therapy plus Propanolol
Arm Type
Experimental
Arm Description
Patients undergo radiation therapy as in Group I. Patients receive propranolol PO BID for 4-6 weeks while receiving CRT in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
(SP-4-2)-diammine[1,1-cyclobutanedicarboxylato(2--)-O,O'']platinum, Blastocarb, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Ribocarbo
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
3 Dimensional Conformal Radiation Therapy
Other Intervention Name(s)
3D-CRT, Radiation
Intervention Description
Undergo 3D CRT
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
2-Propanol-1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy) Hydrochloride, 318-98-9, Inderal, Innopran XL
Intervention Description
Subject will be treated with 30 mg po BID Propranolol for up to 6 weeks
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulated Radiation Therapy
Other Intervention Name(s)
IMRT
Intervention Description
Undergo IMRT
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
33069-62-4, 5Beta,20-epoxy-1,2alpha, Anzatax, Bristaxol, Praxel, Taxol
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Occurrence of Adverse Events
Description
To determine the safety and efficacy of the combination of propranolol plus chemoradiation
Time Frame
Up to 5 years
Title
Progression Free Survival
Description
Imaging findings from first radiation treatment to progression of disease
Time Frame
UP to 5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
will be assessed by chart review of date of last follow-up or date of death
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing definitive or neoadjuvant CRT for histologically confirmed esophageal adenocarcinoma Have an ECOG performance status of 0-1 Have the ability to swallow and retain oral medication. If a patient is not able to swallow, they are still eligible for study provided they have an enteric feeding placed which will permit administration of liquid formula propranolol prior to first radiation treatment Participants of child-bearing potential must have a negative pregnancy test at study entry And then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. - Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: Contraindications to the use of beta-blockers, e.g.; uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New York Heart Association (NYHA) Grade III or IV), hypotension ( systolic blood pressure <100 mmHg), severe asthma or COPD, uncontrolled type I or type II diabetes mellitus (HbA1C >8.5 or fasting plasma glucose > 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,symptomatic congestive heart failure, unstable angina pectoris, psychiatric illness/social situations that would limit compliance with study requirements, cardiac arrhythmia (atrial fibrillation/flutter), severe bradycardia (heart rate of <50 beats per minute or 1st/ 2nd /3rd degree heart block) Pregnant or nursing female participants, Unwilling or unable to follow protocol requirements Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ASK RPCI
Phone
1-800-767-9355
Email
askroswell@roswellpark.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anurag Singh, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma

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