{ "FullStudy":{ "Rank":218111, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512589", "OrgStudyIdInfo":{ "OrgStudyId":"2011-1036" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"NCI-2012-00078", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"NCI CTRP" },{ "SecondaryId":"5U19CA021239", "SecondaryIdType":"U.S. NIH Grant/Contract", "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=5U19CA021239&Fy=all" } ] }, "Organization":{ "OrgFullName":"M.D. Anderson Cancer Center", "OrgClass":"OTHER" }, "BriefTitle":"Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy (IMRT) Trial", "OfficialTitle":"Phase IIB Randomized Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for the Treatment of Esophageal Cancer" }, "StatusModule":{ "StatusVerifiedDate":"May 2019", "OverallStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2020", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"April 2021", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 21, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 23, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"M.D. Anderson Cancer Center", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Massachusetts General Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"National Cancer Institute (NCI)", "CollaboratorClass":"NIH" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"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.\n\nPBT 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.", "DetailedDescription":"Study Treatment:\n\nIf 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:\n\nIf you are in Group 1, you will receive IMRT.\nIf you are in Group 2, you will receive PBT.\n\nYou will receive radiation therapy 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.\n\nYour doctor may think it is in your best interest to also receive chemotherapy while you are receiving radiation therapy. If this occurs, you will sign a separate consent form for these drugs with a full description of how they are given and the risks they may cause.\n\nStudy Visits:\n\nBefore you begin receiving radiation therapy, you will have a baseline visit. The following tests and procedures will be performed:\n\nBlood (about 1-2 tablespoons) will be drawn for routine tests.\nYour performance status will be recorded.\nYou will have a PET/CT or CT scan to check the status of the disease.\nYou will have lung function tests\nYou will complete the symptom and quality of life questionnaires.\nYour esophagus will be examined using an endoscope. If the doctor thinks it is needed, you will have a biopsy to check the status of the disease.\n\nYou will then have a study visit every week while you are receiving radiation therapy. The following tests and procedures will be performed:\n\nYour medical history will be recorded.\nYou will have a physical exam.\nYour performance status, weight, and vital signs will be recorded.\nBlood (about 1-2 tablespoons) will be drawn for routine tests.\nYou will complete the symptom and quality of life questionnaires.\n\nLength of Study:\n\nYou will receive radiation therapy for up to 28 treatments (about 5½ weeks). You will no longer be able to receive radiation therapy if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.\n\nYour participation on the study will be over once you have completed the follow-up visits.\n\nFollow-Up:\n\nAfter you stop receiving radiation therapy, there will be a 4-6 week break. During this time, you will contacted 2 times each week to complete the symptom and quality of life questionnaires. You will receive a call from an automated calling service or from the study staff at a scheduled time of your choosing. You will continue to be followed routinely during treatment and for follow-up visits and tests.\n\nAbout 4-6 weeks after you stop receiving radiation therapy, the following tests and procedures will be performed:\n\nYour medical history will be recorded.\nYou will have a physical exam.\nYour performance status, weight, and vital signs will be recorded.\nYou will have a PET/CT scan to check the status of the disease.\nYou will have lung function tests.\nBlood (about 1-2 tablespoons) will be drawn for routine tests.\nYou will complete the symptom and quality of life questionnaires.\nYour esophagus will be examined using an endoscope. If the doctor thinks it is needed, you will have a biopsy to check the status of the disease.\n\nIf your doctor thinks it is in your best interest after you have completed radiation therapy, you will have surgery to remove the tumor. You will sign a separate consent form that describes the procedure and its risks. As part of this study, the study doctor will check you for side effects and discomfort after the surgery.\n\nEvery 3-4 months for 2 years, and then every 4-6 months for the next 3 years, you will have follow-up visits. The following tests and procedures will be performed:\n\nYour medical history will be recorded.\nYou will have a physical exam.\nYour performance status, weight, and vital signs will be recorded.\nYou will have either a CT or a PET/CT scan to check the status of the disease.\nYou will complete the symptom and quality of life questionnaires. (If the disease gets worse, these questionnaires will no longer be completed.)\n\nAdditionally, the following tests and procedures will be performed at follow-up visits only when the doctor thinks they are needed:\n\nBlood (about 1-2 tablespoons) may be drawn for routine tests.\nYou may have lung function tests.\nYour esophagus will be examined using an endoscope. If the doctor thinks it is needed, you will have a biopsy to check the status of the disease.\n\nYou may be contacted by the study staff to ask about your health, even if you choose not to return to MD Anderson for follow-up visits after completing treatment for esophageal cancer.\n\nThis is an investigational study. IMRT and PBT are delivered using FDA-approved and commercially available methods. It is investigational to compare IMRT to PBT.\n\nUp to 180 patients will take part in this study. All will be enrolled at MD Anderson." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Esophageal Cancer" ] }, "KeywordList":{ "Keyword":[ "Proton Beam Therapy", "PBT", "Intensity-Modulated Radiation Therapy", "IMRT", "Esophageal cancer", "Adenocarcinoma", "Squamous cell carcinoma", "Cervical esophagus", "Thoracic esophagus", "Gastroesophageal junction", "Cardia of stomach", "Questionnaires", "Surveys", "Symptom scores", "Quality of life", "QOL" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"180", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Proton Beam Therapy (PBT)", "ArmGroupType":"Experimental", "ArmGroupDescription":"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).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Radiation: Proton Beam Therapy (PBT)", "Behavioral: Questionnaires" ] } },{ "ArmGroupLabel":"Intensity Modulated Radiation Therapy (IMRT)", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"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).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Radiation: Intensity Modulated Radiation Therapy (IMRT)", "Behavioral: Questionnaires" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Radiation", "InterventionName":"Proton Beam Therapy (PBT)", "InterventionDescription":"1.8 Gy (Relative Biologic Equivalence ((RBE)) to be delivered to the periphery of the planning target volume (PTV) 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Proton Beam Therapy (PBT)" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Radiation Therapy", "XRT" ] } },{ "InterventionType":"Radiation", "InterventionName":"Intensity Modulated Radiation Therapy (IMRT)", "InterventionDescription":"1.8 Gy to be delivered to the periphery of the planning target volume (PTV) 1 time each day, 5 days a week (Monday through Friday) for up to 28 treatments.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Intensity Modulated Radiation Therapy (IMRT)" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Radiation Therapy", "XRT" ] } },{ "InterventionType":"Behavioral", "InterventionName":"Questionnaires", "InterventionDescription":"Symptom and Quality of Life questionnaires completed at baseline, every week during radiation therapy, during break after radiation therapy, and during follow up phase.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Intensity Modulated Radiation Therapy (IMRT)", "Proton Beam Therapy (PBT)" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Surveys" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Progression-Free Survival (PFS)", "PrimaryOutcomeDescription":"Defined from the time of enrollment to the date of death or any recurrence. The progression-free survival (PFS) time distribution will be estimated in each treatment arm using the Kaplan-Meier method.", "PrimaryOutcomeTimeFrame":"6 weeks after radiation therapy" },{ "PrimaryOutcomeMeasure":"Total Toxicity Burden (TTB)", "PrimaryOutcomeDescription":"TTB defined from the time of randomization to 12 months after randomization. Total toxicity burden (TTB) is computed as a composite score from serious adverse events (SAEs) and, among patients who undergo surgery, postoperative complications (POCs).", "PrimaryOutcomeTimeFrame":"12 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAge >/= 18\nHistologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.\nPotentially resectable or unresectable esophageal cancer patients\nInduction chemotherapy prior to concurrent chemoradiation allowed\nPrior Endoscopic Mucosal Resection (EMR) with a diagnosis of stage II-III esophageal cancer is eligible\nPerformance status of Karnofsky Performance Scale (KPS) >/= 60 or Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2.\nPrior thoracic radiation allowable only if there is minimal to no overlap with the treatment area estimated at the time of consultation.\nNegative pregnancy test (serum or urine) for women of child bearing potential. All protocol participants must agree to adequate contraception.\nComplete 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 50 mL/min), and liver function (bilirubin