Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT06946420
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2031-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-04-23', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of symtomps', 'timeFrame': 'From the week after the treatment up to 12 months after', 'description': 'Comparison between the experimental arm and the standard arm in terms of pain reduction or absence of pain (particularly with regard to abdominal pain and widespread pain from disease) using NRS scale, one-dimensional 11-point scale that assesses pain intensity in adult'}], 'secondaryOutcomes': [{'measure': 'Pain level', 'timeFrame': 'From the week after the treatment up to 12 months after', 'description': 'Level of metastasis-associated or primary pain (presence/absence, level and response)'}, {'measure': 'Radiotherapy use', 'timeFrame': 'From the week after the treatment up to 12 months after', 'description': 'Rate of recourse to Radiotherapy for pain, obstruction, bleeding or other symptom referable to the primary at 6 months from randomization (and not present at randomization)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radiation Therapy', 'SBRT', 'Pancreatic Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'Thisi is an Interventional drug-free randomized 1:1 open-label, multicenter, phase 3 trial in patients with first-line metastatic pancreatic cancer. The interventional group of patients will undergo radiotherapy on the primary lesion and SBRT on distal metastatic sites before receiving standard systemic therapy (chemotherapy), while the other group of patients will receive only standard systemic therapy (chemotherapy) without undergoing radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with pancreatic cancer, metastatic, candidate for first-line treatment standard systemic; either newly diagnosed in metastatic stage or first progression to metastasis.\n* Obtaining informed consent\n* Patients \\>18 years of age\n* ECOG 0-2\n* Performance of imaging (CT with mdc, MRI with mdc, CT-PET with appropriate tracer) adequate for baseline local and systemic staging and likely to be similarly repeatable at 6 and 12 months after randomization\n* Confirmation at the time of randomization, by the Radiotherapy Center, that it is possible to perform all treatments potentially planned for the patient (if enrolled in experimental arm) within a maximum of 25 total days prior to referral to the Medical Oncology Center for systemic therapy\n\nExclusion Criteria:\n\n* Metastatic picture of line subsequent to the first\n* Technical or organizational impracticality to the eventual termination of radiation treatments Within 25 days after randomization\n* Inability to express independent consent to treatments\n* Pregnancy\n* Patient in hospice or with prognosis \\< 6 months\n* Predicted unavailability for follow-up at 6 months\n* Absence of adequate or likely non-repeatable pretreatment imaging study at 6 and 12 months\n* Previous radiation therapy\n* Previous radiometabolic therapy\n* Inability to maintain treatment position for SBRT\n* Symptomatic emergent or other presentation precluding study development as planned (e.g., epidural compression of the spinal cord or cauda equina)\n* Previous chemotherapy, immunotherapy or target therapy'}, 'identificationModule': {'nctId': 'NCT06946420', 'acronym': 'SENECA', 'briefTitle': 'SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'SENECA: First Line metaStatic pancrEatic caNcer Primary and Distant (if Oligometastatic) lEsion direCted rAdiotherapy, a Phase III Randomized Multicentric Trial', 'orgStudyIdInfo': {'id': '0001898 24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard systemic therapy (chemotherapy) without RT/SBRT', 'description': 'Patients will undergo only standard systemic treatment (chemotherapy drugs at the discretion of the oncologist) without receiving radiotherapy or stereotactic treatment.', 'interventionNames': ['Drug: Standard systemic therapy (chemotherapy) without RT/SBRT']}, {'type': 'EXPERIMENTAL', 'label': 'RT / SBRT before standard systemic therapy (chemotherapy)', 'description': 'Combination of RT on primary pancreatic Gross Tumor Volume (GTV) (SBRT or RT) + SBRT on each of the distal lesions SBRT or RT will be delivered immediately before the initiation of systemic therapy ((chemotherapy drugs at the discretion of the oncologist))', 'interventionNames': ['Radiation: SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy']}], 'interventions': [{'name': 'SBRT or RT on primary pancreatic and/or metastatic distant lesions before chemotherapy', 'type': 'RADIATION', 'otherNames': ['SBRT', 'Radiation therapy', 'pancreatic cancer'], 'description': 'This group of patients will first undergo radiotherapy on the primary pancreatic lesion and stereotactic treatment on the metastatic sites before being started on standard systemic therapy (chemotherapy)', 'armGroupLabels': ['RT / SBRT before standard systemic therapy (chemotherapy)']}, {'name': 'Standard systemic therapy (chemotherapy) without RT/SBRT', 'type': 'DRUG', 'otherNames': ['systemic therapy', 'No radiation', 'standard'], 'description': 'This group of patients will undergo standard systemic therapy (chemotherapy drugs chosen by oncologist) without radiotherapy treatment', 'armGroupLabels': ['Standard systemic therapy (chemotherapy) without RT/SBRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'RM', 'country': 'Italy', 'facility': 'Policlinico Universitario Agostino Gemelli IRCSS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Manfrida Stefania', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}