Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT00436267
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2007-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Internal Radiation Therapy With Y-90 Microspheres, External Radiation Therapy With Tomotherapy, and Fluorouracil in Treating Patients With Newly Diagnosed or Recurrent Pancreatic Cancer and Liver Metastases That Cannot Be Removed By Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D050486', 'term': 'Serotonin Plasma Membrane Transport Proteins'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D027981', 'term': 'Symporters'}, {'id': 'D016623', 'term': 'Ion Pumps'}, {'id': 'D026901', 'term': 'Membrane Transport Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D050480', 'term': 'Plasma Membrane Neurotransmitter Transport Proteins'}, {'id': 'D050479', 'term': 'Neurotransmitter Transport Proteins'}, {'id': 'D000070590', 'term': 'Solute Carrier Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2007-02-15', 'studyFirstSubmitQcDate': '2007-02-15', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor response'}, {'measure': 'Hepatic and systemic toxicity'}], 'secondaryOutcomes': [{'measure': 'Time to progression'}, {'measure': 'Survival'}]}, 'conditionsModule': {'keywords': ['recurrent pancreatic cancer', 'stage IV pancreatic cancer', 'liver metastases'], 'conditions': ['Metastatic Cancer', 'Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy in different ways and giving it together with chemotherapy may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying the side effects and how well giving internal radiation therapy and external radiation therapy together with fluorouracil works in treating patients with newly diagnosed or recurrent pancreatic cancer and liver metastases that cannot be removed by surgery.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine tumor response in patients with unresectable, newly diagnosed or recurrent pancreatic cancer and liver metastases treated with selective internal radiotherapy with yttrium Y 90 microspheres, selective external radiotherapy with tomotherapy, and fluoroucacil.\n* Determine hepatic and systemic toxicity of this regimen in these patients.\n\nSecondary\n\n* Determine the efficacy of this regimen, in terms of time to progression and survival, in these patients.\n\nOUTLINE: Patients receive fluorouracil IV continuously on days 1-4. Patients undergo selective internal radiotherapy with yttrium Y 90 microspheres on day 2 and selective external radiotherapy with tomotherapy on day 3.\n\nPROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed pancreatic cancer with liver metastases\n\n * Unresectable disease AND meets any of the following criteria:\n\n * Newly diagnosed disease\n\n * No prior treatment\n * Received prior treatment and progressed\n * Underwent prior pancreatectomy and progressed\n * Liver-only disease (receives selective internal radiotherapy only)\n* No known CNS metastases\n* No known diffuse peritoneal metastases\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 80-100%\n* Life expectancy \\> 3 months\n* WBC ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* Hemoglobin ≥ 9 g/dL\n* Bilirubin \\< 2 mg/dL (without extrahepatic biliary obstruction)\n* Albumin \\> 2 g/dL\n* Creatinine \\< 2 mg/dL\n* Not pregnant\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Prior surgery, chemotherapy, and biologic therapy allowed\n* No prior external beam radiotherapy to liver or pancreatic bed'}, 'identificationModule': {'nctId': 'NCT00436267', 'briefTitle': 'Internal Radiation Therapy With Y-90 Microspheres, External Radiation Therapy With Tomotherapy, and Fluorouracil in Treating Patients With Newly Diagnosed or Recurrent Pancreatic Cancer and Liver Metastases That Cannot Be Removed By Surgery', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'CDR0000530018'}, 'secondaryIdInfos': [{'id': 'CCCGHS-SIRT-SERT'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'selective external radiation therapy', 'type': 'RADIATION'}, {'name': 'tomotherapy', 'type': 'RADIATION'}, {'name': 'yttrium Y 90 glass microspheres', 'type': 'RADIATION'}, {'name': 'yttrium Y 90 resin microspheres', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46526', 'city': 'Goshen', 'state': 'Indiana', 'country': 'United States', 'facility': 'Center for Cancer Care at Goshen General Hospital', 'geoPoint': {'lat': 41.58227, 'lon': -85.83444}}], 'overallOfficials': [{'name': 'Kenneth L. Pennington, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Goshen Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goshen Health System', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kenneth Lee Pennington', 'oldOrganization': 'Center for Cancer Care at Goshen General Hospital'}}}}