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New proton beam combo aims to shrink esophageal tumors before surgery

NCT ID NCT02213497

Disease control Sponsor: Abramson Cancer Center at Penn Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a new approach for people with locally advanced esophageal cancer. Before surgery, patients receive proton beam radiotherapy along with two chemotherapy drugs (carboplatin and paclitaxel). The main goal is to find the safest dose and see how well patients tolerate the combination. Only 30 participants are enrolled, so the focus is on safety, not yet on cure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Proton beam radiotherapy combined with carboplatin and paclitaxel chemotherapy
What this could lead to
If successful, this could lead to a safer and more effective way to shrink esophageal tumors before surgery, potentially improving outcomes.
What could go wrong
This is an early phase 1 trial with only 30 participants, focused on safety and dosing. It is too small to prove effectiveness, and side effects from the combined treatment may be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Apr 2014

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina * Patients with AJCC 7th edition clinical stage IIB-IIIC * Patient must be \>18 years of age. * Patients must have an ECOG Performance Status of 0-1 * Patients must be able to provide informed consent. * Patients must be surgical candidates with adequate hematologic, renal, hepatic and pulmonary function * serum AST and ALT \< 2 times the upper limit of normal * Patients must have bilirubin \< 1.5 × normal. * WBC \> 3000/mm3, platelets \> 100,000 mm3. * Hemoglobin \> 10 g/dL serum creatinine \< 1.5 times the upper limit of normal * Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented. Exclusion Criteria: * Patients with primary tumors exceeding 8 cm in length or 5 cm in width ( length should be measured by endoscopic findings, width should be measured by diagnostic CT or CT portion of PET/CT) * Patients with primary tumors located at or above the carina * Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) * Pregnant women, women planning to become pregnant and women that are nursing

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Conditions

The condition(s) this trial relates to.

esophageal adenocarcinoma esophageal cancer Esophageal Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal cancer

Contacts and locations

Locations

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.