Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-11 @ 10:28 PM
Study NCT ID:
NCT05399394
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2022-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction FOLFIRINOX Followed by Chemoradiation in 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': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-30', 'studyFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2022-05-30', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'four months', 'description': 'During treatment, patients are evaluated through a directed history, weekly physical examination and blood exams. The occurrence and nature of any adverse events are recorded in accordance with the National Cancer Institute Common Toxicity Criteria (version 4.02) scale. When multiple treatment-related adverse events of the same type occurred in the same patient, only the most severe ones are reported. Subsequently, the dose of chemotherapy is adjusted according to the number of occurrences of grade 2 or greater events.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '3 years', 'description': 'Overall Survival (OS) is determined from the day of the histological diagnosis. OS curves are calculated with the Kaplan-Meier method.'}, {'measure': 'Progression-free survival', 'timeFrame': '3 years', 'description': 'Progression-free survival (PFS) is obtained from the beginning of treatment to the observation of progression/recurrence, or to last follow-up if no event is observed. PFS curves are calculated with the Kaplan-Meier method.'}, {'measure': 'Metastases-free survival', 'timeFrame': '3 years', 'description': 'Metastases-free survival (MFS) is obtained from the beginning of treatment to the observation of distant progression, or to last follow-up if no event is observed. MFS curves are calculated with the Kaplan-Meier method.'}, {'measure': 'Incidence of Local-regional Tumor Control', 'timeFrame': '3 years', 'description': 'Patients are not considered to have local-regional control unless they achieve at least a partial response of their primary tumor or stable disease by imaging. Patients who do not achieve objective response are considered to have local-regional failure. Local-regional control rates are analyzed using the Kaplan-Meier method.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chemoradiation', 'FOLFIRINOX'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'There is no a clear consensus regarding the optimal treatment strategy of locally advanced pancreatic cancer. There is a potential role for neoadjuvant therapy to treat micrometastatic disease with chemotherapy, as well as for the treatment of local disease with radiotherapy. The investigators evaluated the safety and efficacy of induction FOLFIRINOX followed by a high weekly dose of gemcitabine concurrent to radiation therapy in patients with borderline resectable and unresectable locally advanced pancreatic cancer (LAPC).', 'detailedDescription': 'Continued optimization in multimodality therapy and an accurate patient selection remain crucial points for the appropriate treatment of patients with pancreatic cancer. In all patients an accurate pre-treatment staging was performed, including multilayer CT scan, positron emission computed tomography (PET-CT) with 18F-2-fluoro-2-deoxy-D-glucose (FDG) and laparoscopy with peritoneal washing. Patients with the evidence of metastatic disease were excluded, and thus only a small number of patients was consequently enrolled with this approach.The induction phase of the treatment plan was designed to administer FOLFIRINOX protocol (oxaliplatin 85 mg/mq and irinotecan 180 mg/mq plus leucovorin 400 mg/mq followed by bolus FU 400 mg/mq on day 1, then FU 2,400 mg/mq as a 46-hour continuous infusion) every 14 days for four cycles. In the combined phase of the treatment radiotherapy target volumes were established by CT scan and PET-CT scan. Concurrent chemotherapy consisted of gemcitabine at the dose of 600 mg/mq weekly. Four weeks after the completion of radiochemotherapy, restaging including CT scan and PET-CT scan was performed. Tumor response was defined in accordance with the World Health Organization (WHO) definition through CT scan and PET-CT scan. Surgery was considered in patients whose tumors were technically resectable. After resection, patients were evaluated every three months by means of a standard surveillance protocol that included history and physical examination, cross-sectional imaging and measurement of serum markers, and the intervals were extended to six months after two years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* proven cytological or histological diagnosis of pancreatic ductal adenocarcinoma;\n* borderline resectable or unresectable pancreatic tumours;\n* no previous radiochemotherapy to abdomen;\n* 0-I Eastern Cooperative Oncology Group (ECOG) performance status;\n* adequate cardiac, liver and kidney function and a good bone marrow reserve.\n\nExclusion Criteria:\n\n* resectable and metastatic disease;\n* previous or concomitant malignant disease;\n* one or more of the following clinical conditions: infection, pregnancy or breast-feeding, liver failure, kidney failure, Pa O2 \\< 65 mmHg, Pa carbon dioxide (CO2) \\> 40 mmHg, mental disability.'}, 'identificationModule': {'nctId': 'NCT05399394', 'acronym': 'FOLRT', 'briefTitle': 'Induction FOLFIRINOX Followed by Chemoradiation in Locally Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Campus Bio-Medico University'}, 'officialTitle': 'Induction FOLFIRINOX Followed by Chemoradiation in Locally Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': '2016-000696-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAPC patients', 'description': 'Patients treated with induction FOLFIRINOX; for patients without disease progression as detected through restaging exams, chemotherapy was followed by chemoradiation which consisted of conformal radiation therapy and concurrent gemcitabine at the dose of 600 mg/mq weekly.', 'interventionNames': ['Drug: Chemotherapy', 'Radiation: Radiation']}], 'interventions': [{'name': 'Chemotherapy', 'type': 'DRUG', 'otherNames': ['Induction therapy'], 'description': 'The induction phase of the treatment plan was designed to administer FOLFIRINOX protocol (oxaliplatin 85 mg/mq and irinotecan 180 mg/mq plus leucovorin 400 mg/mq followed by bolus fluorouracil (FU) 400 mg/mq on day 1, then FU 2,400 mg/mq as a 46-hour continuous infusion) every 14 days for four cycles. In the combined phase, concurrent chemotherapy consisted of weekly gemcitabine at the dose of 600 mg/mq.', 'armGroupLabels': ['LAPC patients']}, {'name': 'Radiation', 'type': 'RADIATION', 'description': 'Radiotherapy target volumes are established by CT scan and PET-CT scan. Radiotherapy is delivered with a total dose of 54-59 Gy with fractionation of 1.8 Gy daily for 5 days a week. The Planning Target Volume (PTV) is defined by the Clinical Target Volume (CTV) with a safety margin to include organ motion and set-up errors. Organs at risk for radiation-induced side effects are contoured on the dose planning CT and dose volume histograms (DVH) are calculated. All treatments are delivered with a multifield isocentric technique using a multileaf collimator. A quality-control protocol are applied through cone-beam computed tomography systems (CBCT) for all patients to evaluate the precision of the set-up.', 'armGroupLabels': ['LAPC patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michele Fiore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Campus Bio-Medico University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Campus Bio-Medico University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}