Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-06-25 @ 1:46 AM
Study NCT ID:
NCT03773367
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2018-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000077146', 'term': 'Irinotecan'}], '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': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2018-12-10', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the rate of histopathological response according to Becker criteria.', 'timeFrame': 'After surgery.', 'description': 'Assessment of histopathological response, ypTNM, resection margin and residual tumor status. If Laurén classification and mismatch repair (MMR) or microsatelite instability status (MSI) could not be assessed on pretreatment biopsies it should be assessed on the resected specimen. Results do not have to be awaited before start of chemotherapy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric adenocarcinoma', 'Gastroesophageal junction adenocarcinoma', 'Chemotherapy', 'Fluorouracil', 'Oxaliplatin', 'Irinotecan', 'Preoperative chemotherapy', 'Postoperative chemotherapy', 'Histopathological response', 'Rate of R0-resection'], 'conditions': ['Resectable Gastric and Gastroesophageal Junction Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'In this clinical trial, patients with gastric and gastroesophageal junction adenocarcinoma will be included. Treatment with curative intent will be given with chemotherapy for 4 cycles with fluorouracil, oxaliplatin and irinotecan preoperatively followed by surgery, and then additionally 4 cycles of the same chemotherapy postoperatively. The standard treatment today is preoperative treatment with fluorouracil and oxaliplatin pre-and postoperatively. The rationale for this trial is, that the addition of irinotecan might improve treatments results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically verified, resectable gastric or gastroesophageal (GE) (gastroesophageal) junction (Siewert type I-III) adenocarcinoma Confirmation of patient operability by surgeon\n* Primary tumor, regional nodes, metastasis (TNM), 8th edition): cT2-4a or cN+, cM0\n* Age: 18 years or older\n* World Health Organization (WHO) performance status ≤ 1\n* Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy\n* Adequate laboratory findings:\n\n * hematological: hemoglobin \\> 90 g/L (transfusion is allowed to attain this), absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 75 x 109/L\n * hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) ≤ 3 x ULN\n * renal: creatinine ≤ 1.5 x ULN (upper limit of normal)\n* Fertile men and women must use highly effective means of contraception (failure rate \\<1%) such as:\n\n * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal administration)\n * progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable administration)\n * intrauterine device\n * intrauterine hormone-releasing system\n * bilateral tubal occlusion\n * vasectomised partner\n * sexual abstinence\n* Signed written informed consent\n* The patient must be able to comply with the protocol\n\nExclusion Criteria:\n\n* Neuroendocrine or adenosquamous carcinoma\n* Prior oncological treatment or surgical resection for the present disease\n* Presence of other concurrent malignancies or previous malignancies within 5 years except for adequately treated basal or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix uteri\n* Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure\n* Active inflammatory bowel disease\n* Symptomatic peripheral neuropathy greater than grade 1 (CTCAE version 4.03)\n* Known hypersensitivity to any contents of the study drugs\n* Pregnancy (positive pregnancy test) and/or breast feeding\n* Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial'}, 'identificationModule': {'nctId': 'NCT03773367', 'acronym': 'INTENSE', 'briefTitle': 'Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.', 'organization': {'class': 'OTHER', 'fullName': 'Lund University Hospital'}, 'officialTitle': 'Irinotecan-based Triplet (FOLFOXIRI) as Perioperative Treatment in Resectable Gastric and Gastroesophageal Junction Adenocarcinoma.', 'orgStudyIdInfo': {'id': 'SEGCG18-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with chemotherapy pre- and postoperative.', 'interventionNames': ['Drug: Fluorouracil', 'Drug: Oxaliplatin', 'Drug: Irinotecan']}], 'interventions': [{'name': 'Fluorouracil', 'type': 'DRUG', 'description': 'Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.', 'armGroupLabels': ['Treatment with chemotherapy pre- and postoperative.']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.', 'armGroupLabels': ['Treatment with chemotherapy pre- and postoperative.']}, {'name': 'Irinotecan', 'type': 'DRUG', 'description': 'Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.', 'armGroupLabels': ['Treatment with chemotherapy pre- and postoperative.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0450', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital, Ullevål Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '352 34', 'city': 'Vaxjo', 'country': 'Sweden', 'facility': 'Centrallasarettet i Växjö', 'geoPoint': {'lat': 56.87767, 'lon': 14.80906}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}