Esophageal AdenocarcinomaPhase 2NCT04682158
Propranolol With Chemotherapy or Chemoradiation for Esophageal Adenocarcinoma
A Phase 2 study testing Carboplatin, 3 Dimensional Conformal Radiation Therapy and Propranolol in people with Esophageal Adenocarcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Adenocarcinoma
- What is being tested?
- Carboplatin, 3 Dimensional Conformal Radiation Therapy and Propranolol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Apr 2036
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing definitive or neoadjuvant chemotherapy, chemotherapy-immunotherapy or chemoradiation therapy (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 crushed tablets or 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Propranolol With Definitive or Neoadjuvant Chemotherapy, Chemotherapy-Immunotherapy or Chemoradiation Therapy or Chemoradiation for Esophageal Adenocarcinoma A Phase II Study
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
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the safety and efficacy of propranolol hydrochloride (propranolol) in combination with standard neoadjuvant/definitive chemotherapy or chemotherapy-immunotherapy or chemoradiation therapy (CRT) for esophageal cancer.
SECONDARY OBJECTIVE:
- To estimate overall survival (OS) and pathologic response rate in patients that undergo surgery.
- Conditions
- Esophageal Adenocarcinoma
- Being tested
- Carboplatin, 3 Dimensional Conformal Radiation Therapy, Propranolol, Intensity Modulated Radiation Therapy, Paclitaxel
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called (SP-4-2)-diammine[1,1-cyclobutanedicarboxylato(2--)-O,O'']platinum, Blastocarb, CBDCA, Displata
Given IV
3 Dimensional Conformal Radiation TherapyRadiation
Also called 3D-CRT, Radiation
Undergo 3D CRT
PropranololDrug
Also called 2-Propanol-1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy) Hydrochloride, 318-98-9, Inderal, Innopran XL
Subject will be treated with 30 mg po BID Propranolol for up to 6 weeks
Intensity Modulated Radiation TherapyRadiation
Also called IMRT
Undergo IMRT
PaclitaxelDrug
Also called 33069-62-4, 5Beta,20-epoxy-1,2alpha, Anzatax, Bristaxol
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiation Therapy - Group I | Active comparator | 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. Receives: Drug: Carboplatin; Radiation: 3 Dimensional Conformal Radiation Therapy; Radiation: Intensity Modulated Radiation Therapy; Drug: Paclitaxel |
| Chemoradiation Therapy - Group II | Active comparator | Patients undergo CRT as in Group I in the absence of disease progression or unacceptable toxicity. Receives: Radiation: 3 Dimensional Conformal Radiation Therapy |
| Chemoradiation Therapy plus Propanolol | Experimental | 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. Receives: Radiation: 3 Dimensional Conformal Radiation Therapy; Drug: Propranolol; Radiation: Intensity Modulated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Events
To determine the safety and efficacy of the combination of propranolol plus chemoradiation
Measured: Up to 5 years
Progression Free Survival
Imaging findings from first radiation treatment to progression of disease
Measured: UP to 5 years
Secondary outcomes (1)
Overall Survival
will be assessed by chart review of date of last follow-up or date of death
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Apr 2021
- Primary completion1 Apr 2031 (estimated)
- Study completion1 Apr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anurag Singh, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682158
- Sponsor's protocol ID
- I 630420
- Status last verified
- Oct 2026
- First submitted
- 21 Dec 2020
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided