Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-06 @ 10:49 AM
Study NCT ID:
NCT04097067
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2019-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 83}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2019-09-19', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'Until 6 months after end of treatment', 'description': '4 categories according to GELA-criteria: CR (complete remission) = CR or pMRD (probable minimal residual disease), PR (partial remission) = rRD (responding residual disease), NC (no change), PD (progressive disease)'}], 'secondaryOutcomes': [{'measure': 'QoL #1', 'timeFrame': 'Until 6 months after end of treatment', 'description': 'According to QLQ C30 (EORTC)'}, {'measure': 'QoL #2', 'timeFrame': 'Until 6 months after end of treatment', 'description': 'According to STO22 (EORTC)'}, {'measure': 'EFS', 'timeFrame': 'Until at least 6 months after end of treatment', 'description': 'Event-free survival (time to any failure or death from any cause, patients in CR or PR)'}, {'measure': 'LSS', 'timeFrame': 'Until at least 6 months after end of treatment', 'description': 'Lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients)'}, {'measure': 'PFS', 'timeFrame': 'Until at least 6 months after end of treatment', 'description': 'Progression-free survival (time to progression of lymphoma or death from any cause, all patients)'}, {'measure': 'OS', 'timeFrame': 'Until at least 6 months after end of treatment', 'description': 'Overall survival (time to death from any cause, all patients)'}, {'measure': 'Level of cytokines in blood serum', 'timeFrame': 'Until 6 months after end of treatment', 'description': 'IL-1β, IL-4, IL-8, TNFalpha and other inflammation relevant molecules Syndecan1, MMP-2 and S100 proteins'}, {'measure': 'Acute and chronic toxicities', 'timeFrame': 'Until at least 6 months after end of treatment', 'description': 'Acute toxicities during treatment according to NCI-CTC, chronic toxicities according to NCI-CTC/ LENT-SOMA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphoma', 'Lymphoma, B-Cell, Marginal Zone', 'Neoplasms by Histologic Type', 'Neoplasms', 'Lymphoproliferative Disorders', 'Lymphatic Diseases', 'Immunoproliferative Disorders', 'Immune System Diseases', 'Lymphoma, B-Cell', 'Lymphoma, Non-Hodgkin', 'Lymphoma, follicular'], 'conditions': ['Follicular Lymphoma (Gastric or Duodenal)', 'Marginal Zone Lymphoma (Gastric or Duodenal)']}, 'descriptionModule': {'briefSummary': 'This trial studies the effectivity of low-dose radiation therapy with 10x2Gy for the treatment of patients with stage I-II stomach or duodenal Lymphoma (Marginal Zone or Follicular)', 'detailedDescription': '* Prove the effectiveness of 20 Gy (and non-inferiority to actually recommended 30 Gy) with respect to response rate 6 months after radiotherapy.\n* Correlation of blood serum biomarker levels with lymphoma response to radiation treatment\n* Recording of survival rates, quality of life (QoL), radiogenic toxicities and inflammation relevant molecules in blood serum.\n\nPrimary Objective:\n\nResponse rate 6 months after end of treatment, 4 categories according to GELA-criteria: CR (complete remission) = CR or pMRD (probable minimal residual disease), PR (partial remission) = rRD (responding residual disease), NC (no change), PD (progressive disease)\n\nSecondary Objectives:\n\nQoL according to EORTC (QLQ C30 and STO22). EFS=Event-free survival (time to any failure or death from any cause, patients in CR or PR), LSS=lymphoma-specific survival (time to death related to lymphoma or associated with the treatment, all patients), PFS=Progression-free survival (time to progression of lymphoma or death from any cause, all patients), OS=overall survival (time to death from any cause, all patients). Level of cytokines IL-1β, IL-4, IL-8, TNFalpha and other inflammation relevant molecules Syndecan1, MMP-2 and S100 proteins. Acute toxicities during treatment according to NCI-CTC, chronic toxicities according to NCI-CTC/ LENT-SOMA.\n\nMonitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs)\n\n-Assessment of safety: Monitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary indolent gastric or duodenal lymphoma\n* pathology: marginal zone lymphoma (MZL) or follicular lymphoma (FL)\n* stage: clinical stage I or II (Ann Arbor classification)\n* H. pylori negative or antibiotic resistant lymphoma\n* IPI or FLIPI score low - high (0-4)\n* any size of tumor or affected lymph nodes\n* male or female with age ≥ 18 years\n* performance status ECOG 0 - 3\n* written informed consent by the patient\n\nExclusion Criteria:\n\n* prior radiation treatment of the gastrointestinal lymphoma\n* stage: clinical stage III or IV (Ann Arbor classification)-unability to understand the informed consent or unwillingness to participate in the study\n* severe comorbidity or organ dysfunction contraindicating the use of RT (liver cirrhosis Child-Pugh C, chronic obstructive pulmonary disease GOLD 4, heart insufficiency NYHA IV, dialysis dependent renal insufficiency, uncontrolled epilepsy)\n* known seropositivity for HIV\n* acute hepatitis B or C infection\n* chronic inflammatory bowel disease\n* prior malignant disease (exclusion: basalioma, non-metastasized solid tumor in constant remission diagnosed \\>3 years ago)\n* pregnancy or breastfeeding\n* active substance abuse or severely compromised compliance'}, 'identificationModule': {'nctId': 'NCT04097067', 'briefTitle': 'ISRT 20 Gy for Indolent Localized Gastrointestinal (GI)-Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Phase II Trial to Assess the Efficacy of Low Radiation Dose of 20 Gy for the Treatment of Marginal Zone Lymphoma or Follicular Lymphoma Stage I-II Localized in the Stomach or the Duodenum', 'orgStudyIdInfo': {'id': 'UKM01_2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (low-dose radiation therapy)', 'description': 'Patients undergo low-dose radiation therapy with daily 2 Gy ad 20 Gy (ISRT with IMRT \\& IGRT).\n\nBlood draw for biomarker-analysis (at baseline visit/ after 4 Gy/ after 10 Gy / after 20 Gy RT/ at 3 and 6 months after RT)', 'interventionNames': ['Radiation: Radiation Therapy']}], 'interventions': [{'name': 'Radiation Therapy', 'type': 'RADIATION', 'description': 'Low dose radiotherapy with 20 Gy (10x2Gy)', 'armGroupLabels': ['Treatment (low-dose radiation therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Gabriele Reinartz, MD (Priv. Doz.)', 'role': 'CONTACT', 'email': 'gabriele.reinartz@ukmuenster.de', 'phone': '+492518347358'}, {'name': 'Stephan Rehn, MD', 'role': 'CONTACT', 'email': 'stephan.rehn@ukmuenster.de', 'phone': '+492518347358'}], 'facility': 'Department of Radiation Oncology', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'centralContacts': [{'name': 'Gabriele Reinartz, MD (Priv. Doz.)', 'role': 'CONTACT', 'email': 'gabriele.reinartz@ukmuenster.de', 'phone': '+492518347358'}, {'name': 'Tina Fischer', 'role': 'CONTACT', 'email': 'tina.fischer@ukmuenster.de', 'phone': '+492518347358'}], 'overallOfficials': [{'name': 'Prof. Dr. H. Th. Eich', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology University Hospital Muenster'}, {'name': 'Priv. Doz. Dr. G. Reinartz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology University Hospital Muenster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Lymphoma Radiation Oncology Group (ILROG)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}