Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 4:25 AM
Study NCT ID:
NCT01304160
Status:
COMPLETED
Last Update Posted:
2016-08-05
First Post:
2011-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-03', 'studyFirstSubmitDate': '2011-02-21', 'studyFirstSubmitQcDate': '2011-02-24', 'lastUpdatePostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'one year', 'description': 'Acute and chronic toxicities will be evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '3 monthly', 'description': 'Quality of life will be evaluated with the EORTC QLQ-C30 questionnaire'}, {'measure': 'Local control', 'timeFrame': '3 monthly', 'description': 'Local control will be assessed with 3 monthly CT-scans of the abdomen. RECIST criteria will be used to evaluate local control.'}, {'measure': 'overall survival', 'timeFrame': 'one and two year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pancreatic cancer', 'stereotactic body radiotherapy', 'radiation', 'gemcitabine', 'locally advanced'], 'conditions': ['Pancreatic Cancer', 'Unresectable Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of stereotactic radiation therapy given in five fractions (30 Gray in 5 fractions) followed by gemcitabine in patients with locally advanced pancreatic cancer.', 'detailedDescription': 'The purpose of this phase I/II study is to evaluate the efficacy and toxicity of a different stereotactic body radiation therapy regimen combined with gemcitabine. In the present study, 5 daily fractions of 6 Gray will be given over two weeks. Stereotactic body radiation therapy will be given with the Cyberknife system. This treatment technique allows to give a higher dose to the tumor as compared to conventional external beam radiation while lowering the dose to the normal tissues around. This treatment system is also capable of following the motion that the pancreas assumes during respiration as well as during treatment. This enables us to reduce the margin of security and further reduce dose to surrounding normal tissue.\n\nThe primary objective of this study is to evaluate acute and chronic toxicity of this regimen of stereotactic radiation therapy followed by gemcitabine. Quality of life, local control and overall survival will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pancreatic Adenocarcinoma, histologically and/or cytologically proven\n* Locally advanced pancreatic cancer, surgically non resectable\n* No distant metastasis\n* Work-up including medical history, physical exam, biochemistry, chest X-ray, CT-scan of abdomen and pelvis\n* ECOG performance status : ≤ 2\n* Primary tumor visible on CT-scan\n* Maximum tumor diameter of 6 cm (including primary tumor and regional lymph nodes)\n* White blood cell count \\> 3000 /uL, Neutrophils \\> 1500 /uL, Platelets \\> 100 000/uL, Hemoglobin \\> 95 mg/L, Total bilirubin \\< 1,5 normal limit, AST/ALT \\< 2,5 normal limit, normal creatinin\n* ≥ 18 years of age\n* Signed informed consent\n\nExclusion Criteria:\n\n* Prior abdominal radiation therapy\n* Connective tissue disease (scleroderma, lupus)\n* Prior treatment for pancreatic cancer such as radiation therapy, chemotherapy or surgery.'}, 'identificationModule': {'nctId': 'NCT01304160', 'briefTitle': 'Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Phase I/II Study to Investigate the Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'CE 09.153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'strereotactic radiotherapy, gemcitabine', 'description': 'stereotactic radiotherapy (30Gray in 5 fractions) followed by gemcitabine', 'interventionNames': ['Radiation: stereotactic body radiotherapy']}], 'interventions': [{'name': 'stereotactic body radiotherapy', 'type': 'RADIATION', 'description': '30Gray in 5 fractions', 'armGroupLabels': ['strereotactic radiotherapy, gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Université de Montréal (CHUM)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Marie-Pierre Campeau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'collaborators': [{'name': "Centre de Recherche du Centre Hospitalier de l'Université de Montréal", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}