Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-26 @ 7:25 AM
Study NCT ID:
NCT05054959
Status:
RECRUITING
Last Update Posted:
2021-09-23
First Post:
2021-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D060830', 'term': 'Consolidation Chemotherapy'}, {'id': 'D060828', 'term': 'Induction Chemotherapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012074', 'term': 'Remission Induction'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-19', 'studyFirstSubmitDate': '2021-09-19', 'studyFirstSubmitQcDate': '2021-09-19', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete remission rate', 'timeFrame': '2 weeks after completiton of TNT', 'description': 'The proportion of complete responses will be defined as the sum of the proportions of pCR in operated patients and cCR in non-operated patients.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'after 3 years of follow-up', 'description': 'time from randomization to death'}, {'measure': 'Survival without recurrence of the disease', 'timeFrame': 'after 3 years of follow-up', 'description': 'time from the end of treatment (in the case of cCR) or from radical surgery to death or recurrence of the disease - whichever comes first.'}, {'measure': 'Disease free survival', 'timeFrame': 'after 3 years of follow-up', 'description': 'the time from the end of treatment (in the case of cCR) or surgery to the recurrence of disease, the onset of new cancer, death from cancer or other causes'}, {'measure': 'local control', 'timeFrame': 'after 3 years of follow-up', 'description': 'the time from the end of the treatment (in the case of cCR) or surgery to local recurrence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rectal cancer', 'total neoadjuvant therapy', 'induction chemotherapy', 'consolidation chemotherapy'], 'conditions': ['Locally Advanced Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '24717570', 'type': 'BACKGROUND', 'citation': 'Cercek A, Goodman KA, Hajj C, Weisberger E, Segal NH, Reidy-Lagunes DL, Stadler ZK, Wu AJ, Weiser MR, Paty PB, Guillem JG, Nash GM, Temple LK, Garcia-Aguilar J, Saltz LB. Neoadjuvant chemotherapy first, followed by chemoradiation and then surgery, in the management of locally advanced rectal cancer. J Natl Compr Canc Netw. 2014 Apr;12(4):513-9. doi: 10.6004/jnccn.2014.0056.'}, {'pmid': '33643528', 'type': 'BACKGROUND', 'citation': 'Tuta M, Boc N, Brecelj E, Peternel M, Velenik V. Total neoadjuvant therapy vs standard therapy of locally advanced rectal cancer with high-risk factors for failure. World J Gastrointest Oncol. 2021 Feb 15;13(2):119-130. doi: 10.4251/wjgo.v13.i2.119.'}, {'pmid': '31652124', 'type': 'BACKGROUND', 'citation': 'Tuta M, Boc N, Brecelj E, Omejc M, Anderluh F, Ermenc AS, Peressutti AJ, Oblak I, Krebs B, Velenik V. Total neoadjuvant treatment of locally advanced rectal cancer with high risk factors in Slovenia. Radiol Oncol. 2019 Oct 25;53(4):465-472. doi: 10.2478/raon-2019-0046.'}, {'pmid': '31150315', 'type': 'BACKGROUND', 'citation': 'Fokas E, Allgauer M, Polat B, Klautke G, Grabenbauer GG, Fietkau R, Kuhnt T, Staib L, Brunner T, Grosu AL, Schmiegel W, Jacobasch L, Weitz J, Folprecht G, Schlenska-Lange A, Flentje M, Germer CT, Grutzmann R, Schwarzbach M, Paolucci V, Bechstein WO, Friede T, Ghadimi M, Hofheinz RD, Rodel C; German Rectal Cancer Study Group. Randomized Phase II Trial of Chemoradiotherapy Plus Induction or Consolidation Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: CAO/ARO/AIO-12. J Clin Oncol. 2019 Dec 1;37(34):3212-3222. doi: 10.1200/JCO.19.00308. Epub 2019 May 31.'}, {'pmid': '30210040', 'type': 'BACKGROUND', 'citation': 'Golo D, But-Hadzic J, Anderluh F, Brecelj E, Edhemovic I, Jeromen A, Omejc M, Oblak I, Secerov-Ermenc A, Velenik V. Induction chemotherapy, chemoradiotherapy and consolidation chemotherapy in preoperative treatment of rectal cancer - long-term results of phase II OIGIT-01 Trial. Radiol Oncol. 2018 Sep 11;52(3):267-274. doi: 10.2478/raon-2018-0028.'}, {'pmid': '27727065', 'type': 'BACKGROUND', 'citation': 'But-Hadzic J, Anderluh F, Brecelj E, Edhemovic I, Secerov-Ermenc A, Hudej R, Jeromen A, Kozelj M, Krebs B, Oblak I, Omejc M, Vogrin A, Velenik V. Acute Toxicity and Tumor Response in Locally Advanced Rectal Cancer After Preoperative Chemoradiation Therapy With Shortening of the Overall Treatment Time Using Intensity-Modulated Radiation Therapy With Simultaneous Integrated Boost: A Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2016 Dec 1;96(5):1003-1010. doi: 10.1016/j.ijrobp.2016.08.031. Epub 2016 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to identify the most promising sequence of modalities in total neoadjuvant treatment of localy advanced rectal cancer with high risk of recurrence', 'detailedDescription': 'International recommendations for the treatment of LARC with a high risk of disease recurrence are inconsistent, regarding TNT. In Germain randomised study more pCR were achieved with consolidation chemotherapy. We will compare our standard approach (induction plus consolidation CT) with consolidation CT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:- histologically proven rectal adenocarcinoma\n\n* no distant metastases on CT scan (M0 disease)\n* at least one high risk factor for disease recurrence identified on MR imaging:\n\n * T4 tumor (cT4)\n * N2 disease (cN2)\n * extramural venous invasion (cEMVI+)\n * positive lateral lymph nodes\n * distance of tumor to mesorectal fascia or positive lymph nodes is 1 mm or less (cMRF+)\n* capacity for informed consent\n* willingness to attend regular check-ups during and after treatment\n\nExclusion Criteria:history of previous irradiation in the pelvic area\n\n* absolute contraindications for MR imaging\n* distant metastases cannot be reliably excluded\n* synchronous cancer\n* chronic inflammatory bowel disease'}, 'identificationModule': {'nctId': 'NCT05054959', 'acronym': 'ICONA', 'briefTitle': 'Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Oncology Ljubljana'}, 'officialTitle': 'Induction Versus Consolidation Chemotherapy in Total Neoadjuvant Therapy of Localy Advanced Rectal Cancer With High Risk of Recurrence (ICONA Study)', 'orgStudyIdInfo': {'id': 'KME 0120-214/2021/3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'consolidation chemotherapy', 'description': 'chemoradiation: intensity-modulated irradiation technique with simultaneous integrated boost to the tumor (IMRT-SIB) or with volumetric modulated arc therapy (VMAT) with simultaneous integrated boost (VMAT-SIB) to the total tumor dose of 46.2 Gy in T1-3 tumors and 48.4 Gy in T4 tumors in 22 fractions with concomitant CT with capecitabine (dosage: 825 mg / m2 / 12 h per os continuously from the first to the last day of irradiation).\n\n6 cycles of CAPOX chemotherapy. One cycle of CAPOX CT lasts 3 weeks and consists of capecitabine 1000 mg / m2 / 12h per os for 1-14 days and oxaliplatin 130 mg / m2 intravenously in a two-hour infusion on day 1.', 'interventionNames': ['Other: consolidation chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'induction chemotherapy', 'description': '4 cycles of induction CAPOX chemotherapy. One cycle of CAPOX CT lasts 3 weeks and consists of capecitabine 1000 mg / m2 / 12h per os for 1-14 days and oxaliplatin 130 mg / m2 intravenously in a two-hour infusion on day 1.\n\nChemoradiation:intensity-modulated irradiation technique with simultaneous integrated boost to the tumor (IMRT-SIB) or with volumetric modulated arc therapy (VMAT) with simultaneous integrated boost (VMAT-SIB) to the total tumor dose of 46.2 Gy in T1-3 tumors and 48.4 Gy in T4 tumors in 22 fractions with concomitant CT with capecitabine (dosage: 825 mg / m2 / 12 h per os continuously from the first to the last day of irradiation).\n\n2 cycles of consolidation CAPOX chemotherapy.', 'interventionNames': ['Other: induction chemotherapy']}], 'interventions': [{'name': 'consolidation chemotherapy', 'type': 'OTHER', 'description': '6 cycles CAPOX after chemoradiotherapy', 'armGroupLabels': ['consolidation chemotherapy']}, {'name': 'induction chemotherapy', 'type': 'OTHER', 'description': '4 cycles CAPOX before and 2 cycles CAPOX after chemoradiotherapy', 'armGroupLabels': ['induction chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Vaneja Velenik, PhD', 'role': 'CONTACT', 'email': 'vvelenik@onko-i.si', 'phone': '+386 1 5879 297'}, {'name': 'Miha Orazem, MD', 'role': 'CONTACT', 'email': 'morazem@onko-i.si', 'phone': '+386 1 5879 294'}, {'name': 'Vaneja Velenik, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Franc Anderluh, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ajra Secerov ErmencOblak, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Janja Ocvirk, PhD, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Erik Brecelj, PhD, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Miha Orazem, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institute of Oncology', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Vaneja Velenik, PhD', 'role': 'CONTACT', 'email': 'vvelenik@onko-i.si', 'phone': '+386 15879297'}, {'name': 'Miha Orazem, MD', 'role': 'CONTACT', 'email': 'morazem@oko-i.si', 'phone': '+386 58792941'}], 'overallOfficials': [{'name': 'Vaneja Velenik, PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Oncology Ljubljana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Oncology Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Institute of Oncology Ljubljana', 'investigatorFullName': 'Violeta Kaluza', 'investigatorAffiliation': 'Institute of Oncology Ljubljana'}}}}