Clinical trial · Interventional
Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy (IMRT) Trial
Phase IIB Randomized Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for the Treatment of Esophageal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn how safe and effective proton-beam therapy (PBT) may be in comparison to intensity modulated radiation therapy (IMRT) in combination with chemotherapy in patients with esophageal cancer. PBT and IMRT are both forms of radiation therapy that are designed to treat a specific area of the body while affecting as little of the surrounding normal tissue as possible. PBT is a newer technology that is designed to further reduce the amount of radiation that affects the surrounding normal tissue. However, this is still being studied.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity Modulated Radiation Therapy (IMRT) | Radiation | — | UNRESOLVED |
| Proton Beam Therapy (PBT) | Radiation | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Proton Beam Therapy (PBT)
- description
- Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy (or at RBE ("Relative Biologic Equivalence" for PBT)) to be delivered to the periphery of the planning target volume (PTV).
- interventionNames
- Radiation: Proton Beam Therapy (PBT)
- Behavioral: Questionnaires
- type
- ACTIVE_COMPARATOR
- label
- Intensity Modulated Radiation Therapy (IMRT)
- description
- Radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments. 1.8 Gy to be delivered to the periphery of the planning target volume (PTV).
- interventionNames
- Radiation: Intensity Modulated Radiation Therapy (IMRT)
- Behavioral: Questionnaires
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDWang X, van Rossum PSN, Chu Y, Hobbs BP, Grassberger C, Hong TS, Liao Z, Yang J, Zhang X, Netherton T, Mohan R, Lin SH. Severe Lymphopenia During Chemoradiation Therapy for Esophageal Cancer: Comprehensive Analysis of Randomized Phase 2B Trial of Proton Beam Therapy Versus Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. 2024 Feb 1;118(2):368-377. doi: 10.1016/j.ijrobp.2023.08.058. Epub 2023 Aug 29. PMID 37652304
- DERIVEDLin SH, Hobbs BP, Verma V, Tidwell RS, Smith GL, Lei X, Corsini EM, Mok I, Wei X, Yao L, Wang X, Komaki RU, Chang JY, Chun SG, Jeter MD, Swisher SG, Ajani JA, Blum-Murphy M, Vaporciyan AA, Mehran RJ, Koong AC, Gandhi SJ, Hofstetter WL, Hong TS, Delaney TF, Liao Z, Mohan R. Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer. J Clin Oncol. 2020 May 10;38(14):1569-1579. doi: 10.1200/JCO.19.02503. Epub 2020 Mar 11. PMID 32160096