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New proton therapy may reduce side effects in esophageal cancer treatment

NCT ID NCT01512589

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two radiation methods—proton beam therapy and standard intensity-modulated radiation therapy—for people with esophageal cancer. Both are given alongside chemotherapy. The goal is to see if the newer proton therapy is safer and more effective at controlling the cancer while causing fewer side effects. About 147 adults with stage II-III esophageal cancer are taking part.

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 therapy (PBT) and intensity-modulated radiation therapy (IMRT)
What this could lead to
If proton therapy works better, it could offer a more precise radiation option for esophageal cancer with fewer side effects.
What could go wrong
This is a mid-stage trial with 147 participants, so results are not yet conclusive. Proton therapy is newer and may not prove superior to standard radiation.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

147 people

The number who actually took part.

Started

Apr 2012

Expected to finish

Apr 2027

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: 1. Age \>/= 18 2. Histologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach. 3. Potentially resectable or unresectable esophageal cancer patients 4. Induction chemotherapy prior to concurrent chemoradiation allowed 5. Prior Endoscopic Mucosal Resection (EMR) with a diagnosis of stage II-III esophageal cancer is eligible 6. Performance status of Karnofsky Performance Scale (KPS) \>/= 60 or Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2. 7. Prior thoracic radiation allowable only if there is minimal to no overlap with the treatment area estimated at the time of consultation. 8. Negative pregnancy test (serum or urine) for women of child bearing potential. All protocol participants must agree to adequate contraception. 9. Complete blood count (CBC) and complete metabolic panel (chemo-14: Glucose, Calcium, Albumin, Total Protein, Sodium, Potassium, Carbon Dioxide (CO2), Chloride, Blood Urea Nitrogen (BUN), Creatinine, Alkaline Phosphatase, Alanine Aminotransferase (ALT) Serum Glutamic Pyruvic Transaminase (SGPT), Aspartate Aminotransferase (AST) Serum Glutamic-oxaloacetic Transaminase (SGOT), and Bilirubin) to assess adequate hematologic, renal and hepatic functioning will be obtained. The values are as follows: Adequate hematologic (White Blood Count (WBC) \>2,500/uL, platelets \> 75,000/uL), renal (Serum creatinine \</= 1.5X Upper Limit of Normal (ULN) or creatinine clearance \> 50 mL/min), and liver function (bilirubin \</=1.5 fold the upper limit of normal and liver enzymes \< 3 fold the upper limit of normal) 10. Able to communicate in the English language. 11. Any patient deemed eligible for chemoradiation for esophageal cancer treatment. Exclusion Criteria: 1. Patients with active second malignancy are allowed as long as it is determined by the treating physician that the treatment of esophageal cancer is of higher priority through proper evaluation. However patients with active stage 4, metastatic cancers, receiving other systemic therapies at the time of the esophageal cancer diagnosis, will not be eligible. 2. Pregnant or breast-feeding females 3. Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: a) active uncontrolled infection; b) Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device; c) no myocardial infarction within 3 months of registration 4. Radiation treatment alone without concurrent chemotherapy or chemotherapy use alone.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

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