Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-24 @ 4:31 PM
Study NCT ID:
NCT01684904
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2012-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proton Therapy for Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061766', 'term': 'Proton Therapy'}], 'ancestors': [{'id': 'D063193', 'term': 'Heavy Ion Radiotherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2032-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2012-09-07', 'studyFirstSubmitQcDate': '2012-09-10', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess overall survival of patients treated with proton-chemotherapy (PCT) followed by surgery in patients with resectable primary esophageal or esophagogastric cancer', 'timeFrame': 'The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events as a measure of safety and tolerability', 'timeFrame': 'The major analysis for reporting the initial results of treatment will be undertaken when each patient has been potentially followed for a minimum of 3 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Esophagus Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this phase II study is to investigate the feasibility, toxicity and efficacy of a regimen incorporating a proven systemic regimen, carboplatin /paclitaxel, with conformal proton modality, followed by definitive surgery. In most combined-modality trials to date, chemotherapy regimens have included cisplatin, usually in conjunction with 5-fluorouracil.\n\nIn designing the regimen, the investigators attempt to improve on the standard cisplatin/5-fluorouracil regimen in several ways. First, full-dose paclitaxel is added to the regimen. This agent has activity against advanced esophageal cancer and is also a potent radiosensitizer. Second, the substitution of carboplatin for cisplatin has resulted in reduced toxicity of various combination regimens similar to that used by CROSS trial and allows for easier administration in the outpatient setting.4 Third, for localized esophageal cancer, dose distribution patterns achievable with proton beam could potentially offer important clinical advantages relative to those achievable with x-rays (photons).19 Based on this, the investigators believe that this study should be conducted with the radiation modality that offers the best dosimetry achievable at our institution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologically confirmed primary squamous cell or adenocarcinoma of the esophagus that involves the mid, distal or esophagogastric junction. The cancer may involve the stomach up to 5 cm.\n* Endoscopy with biopsy\n* Stage T1N102, T2-3N0-2 according to the American Joint Committee on Cancer (AJCC) 7th edition staging, based upon the following minimum diagnostic work-up:\n\nHistory/physical examination with documentation of patient's weight within 30 days of registration\n\nChest/Abdominal/Pelvic contrast CT within 56 days of registration\n\nWhole body PET/CT within 56 days of registration\n\nEndoscopic ultrasound\n\nPatients may have regional adenopathy including para-esophageal, gastric, gastroheptaic and celiac nodes. If celiac adenopathy present, it must be ≤ 2cm.\n\nPatients with tumors at the level of the carina or above should undergo bronchoscopy to exclude fistula\n\nPulmonary function test (including routine spirometry and DLCO) within 60 days prior to registration\n\nSerum creatinine ≤ 2 x the upper limit of normal within 4 weeks of registration\n\nNa, K, BUN, Glucose within 4 weeks prior to registration\n\nCBC/differential within 4 weeks prior to registration with adequate bone marrow function, defined as follows:\n\n* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3\n* Platelets ≥ 100,000 cell/mm3\n* Hemoglobin ≥ 8.0 g/dl (Note: the use of transfusion or other intervention to achieve Hgb ≥ 8.0 is acceptable.)\n\nAdequate liver function, defined as total bilirubin ≤ 1.5 x upper limit of normal, AST ≤ 3 x the upper limit of normal within 4 weeks of registration\n\nAge ≥ 18\n\nZubrod performance status 0-2 within 4 weeks of registration\n\nSurgical consultation to confirm that patient will be able to undergo curative resection after completion of PCT prior to registration\n\nFor women of childbearing potential, a negative serum pregnancy test within 14 days prior to registration\n\nWomen of childbearing potential and male participants must practice adequate contraception while on study\n\nPatient must sign study specific informed consent prior to study entry\n\nExclusion Criteria:\n\nPatients with cervical esophageal carcinoma\n\nPatients with T1N0 disease and T4 disease\n\nPrior radiation for esophageal cancer or prior chest radiotherapy\n\nPrior chemotherapy for esophageal cancer\n\nEvidence of tracheoesophageal fistula or invasion into the trachea or major bronchi\n\nPrior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 2 years ( e.g. carcinoma in situ of breast, oral cavity, or cervix are permissible)\n\nPrior radiotherapy that would results in overlap of radiation fields\n\nMedical contraindications to esophagectomy\n\nPrior allergic reaction to paclitaxel or carboplatin\n\nSevere, active co-morbidity that may impact survival\n\nPregnancy, nursing women, or women of child bearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception\n\n\\-"}, 'identificationModule': {'nctId': 'NCT01684904', 'briefTitle': 'Proton Therapy for Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'A Phase II Trial of Proton Chemotherapy (PCT) for Resectable Esophageal or Esophagogastric Junction Cancer', 'orgStudyIdInfo': {'id': '5120054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proton radiation', 'description': 'Proton radiation', 'interventionNames': ['Radiation: Proton radiation']}], 'interventions': [{'name': 'Proton radiation', 'type': 'RADIATION', 'armGroupLabels': ['Proton radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gary Yang, MD', 'role': 'CONTACT', 'email': 'gyang@llu.edu', 'phone': '909-558-4280'}, {'name': 'Gary Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'centralContacts': [{'name': 'Proton Referral Office First call: Referral Office intake personnel', 'role': 'CONTACT', 'phone': '909-558-4288 or 1 800 PROTONS'}, {'name': 'Gary Yang, MD', 'role': 'CONTACT', 'email': 'gyang@llu.edu', 'phone': '909-558-4000', 'phoneExt': '15689'}], 'overallOfficials': [{'name': 'Gary Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'gyang@llu.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}