New proton therapy may reduce side effects in esophageal cancer treatment
NCT ID NCT01512589
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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147 people
The number who actually took part.
- Started
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Apr 2012
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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