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NCT01512589Active, not recruitingPhase 2

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 · Last updated 6 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
147 (actual)
First submitted
13 Jan 2012
Start date
30 Apr 2012
Primary completion date
30 Apr 2027
Lead sponsor
M.D. Anderson Cancer Center
NCT number
NCT01512589

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 147
  • From 30 Apr 2012 to the primary completion date, 30 Apr 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Radiation treatment alone without concurrent chemotherapy or chemotherapy use alone.

Other illness

  • 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

Other

  • Pregnant or breast-feeding females

Who the study is looking for

  • Age \>/= 18
  • Histologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.
  • Potentially resectable or unresectable esophageal cancer patients
  • Induction chemotherapy prior to concurrent chemoradiation allowed
  • Prior Endoscopic Mucosal Resection (EMR) with a diagnosis of stage II-III esophageal cancer is eligible
  • Performance status of Karnofsky Performance Scale (KPS) \>/= 60 or Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.
  • Prior thoracic radiation allowable only if there is minimal to no overlap with the treatment area estimated at the time of consultation.
  • Negative pregnancy test (serum or urine) for women of child bearing potential. All protocol participants must agree to adequate contraception.
  • 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)
  • Able to communicate in the English language.
  • Any patient deemed eligible for chemoradiation for esophageal cancer treatment.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.