Status:
ACTIVE_NOT_RECRUITING
Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy (IMRT) Trial
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Massachusetts General Hospital
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 chemother...
Detailed Description
Study Treatment: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups: * If you are in Group 1, you will receiv...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Pregnant or breast-feeding females
- 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
- Radiation treatment alone without concurrent chemotherapy or chemotherapy use alone.
Key Trial Info
Start Date :
April 30 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2027
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT01512589
Start Date
April 30 2012
End Date
April 30 2027
Last Update
October 10 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030