Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-01-05 @ 6:36 PM
Study NCT ID:
NCT04095468
Status:
RECRUITING
Last Update Posted:
2019-09-19
First Post:
2019-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 215}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2019-09-13', 'studyFirstSubmitQcDate': '2019-09-17', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentages of cCR and near-cCR in the patients with "resectable" cancer', 'timeFrame': '11 weeks from the start of radiotherapy'}, {'measure': 'Percentages of cCR and near-cCR in the patients with threatened mesorectal fascia.', 'timeFrame': '11 weeks from the start of radiotherapy'}, {'measure': 'Percentages of cCR and near-cCR in relation to the selected tumour characteristics.', 'timeFrame': '11 weeks from the start of radiotherapy', 'description': 'The selected tumour characteristics: TN categories, tumour length, degree of circumferential involvement, tumour mobility on digital rectal examination (mobile, tethered, fixed) and status of mesorectal fascia (threatened or not).'}, {'measure': 'Percentages of pCR in the patients after total mesorectal excision performed because of tumour persistence.', 'timeFrame': '12 weeks from the start of radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Local regrowth rate', 'timeFrame': '5 years'}, {'measure': 'Disease-free survival', 'timeFrame': '3 years'}, {'measure': 'Overall survival', 'timeFrame': '5 years'}, {'measure': 'Anorectal function assessed by low anterior resection syndrome (LARS) score', 'timeFrame': '3 years', 'description': 'The questionnaire will be completed by patients. It includes 5 items related to anorectal function. The range of the score (0-42) is divided into 0 to 20 (no LARS), 21 to 29 (minor LARS) and 30 to 42 (major LARS).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rectal cancer', 'preoperative radiotherapy', 'organ preservation', 'watch-and-wait'], 'conditions': ['Rectal Neoplasms', 'Rectal Cancer']}, 'descriptionModule': {'briefSummary': "Watch-and-wait strategy in rectal cancer is gaining momentum. There is a large variability in reporting the proportion of patients achieving clinical complete response (cCR) after routinely delivered preoperative radio(chemo)therapy, likely because of patients' selection. This proportion in population-based level is poorly defined. In addition, predictive factors for cCR are also poorly defined. It is known that cCR response is observed often in small tumours. However, cCR proportion in large cancers has not been sufficiently evaluated. For example, even though pathological complete response (pCR) does occur in large fixed cancer, it is unknown whether cCR does also occur because persistent fibrous stroma may mimic residual cancer in all of such cases.\n\nThis is a prospective observational population-based cohort study on low rectal cancer to answer the question of how often clinical or near-clinical tumour response occur after routinely delivered preoperative radiotherapy in relation to the pre-treatment tumour characteristics. The additional question was how often pCR occur in relation to the pre-treatment tumour characteristics in the patients managed by total mesorectal excision because of persistent tumour after radiotherapy. The additional aim was the implementation of watch-and-wait strategy or full-thickness local excision (as an option instead of total mesorectal excision in the patients with sustained near-cCR) within a frame of a prospective study. In the patients managed by organ preservation, the secondary outcome measures were: i) local regrowth rate, ii) effectiveness of salvage surgery, iii) disease-free survival at 3 years and overall survival at 5 years, iv) anorectal function."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '140 patients with "resectable" cancer and 75 patients with threatened mesorectal fascia as assessed on multidisciplinary tumor board.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary rectal cancer\n* Low tumour (accessible by digital rectal examination)\n* Routine preoperative radio(chemo)therapy according to the institutional policy; short-course radiation and immediate surgery is not allowed.\n* Informed consent for watch-and-wait strategy or local excision in patients with cCR and near-cCR\n\nExclusion Criteria:\n\n* Recurrent cancer\n* Cancers situated in the upper rectum\n* Distant metastases'}, 'identificationModule': {'nctId': 'NCT04095468', 'briefTitle': 'Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Maria Sklodowska-Curie National Research Institute of Oncology'}, 'officialTitle': 'Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer', 'orgStudyIdInfo': {'id': 'ORGANPRESERV1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Resectable rectal cancer', 'interventionNames': ['Radiation: Preoperative Radio(Chemo)Therapy']}, {'label': 'Rectal cancer with threatened mesorectal fascia', 'interventionNames': ['Radiation: Preoperative Radio(Chemo)Therapy']}], 'interventions': [{'name': 'Preoperative Radio(Chemo)Therapy', 'type': 'RADIATION', 'description': 'Preoperative radiotherapy +/- chemotherapy, then surgery (total mesorectal excision) or watch-and-wait', 'armGroupLabels': ['Rectal cancer with threatened mesorectal fascia', 'Resectable rectal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-781', 'city': 'Warsaw', 'state': 'Mazovian', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Krzysztof Bujko, M.D. PhD', 'role': 'CONTACT', 'email': 'Krzysztof.Bujko@coi.pl', 'phone': '+48601207466'}, {'name': 'Krzysztof Bujko, M.D. PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maria Skłodowska-Curie Institute - Oncology Center', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Bydgoszcz', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Michał Jankowski, M.D.', 'role': 'CONTACT'}, {'name': 'Michał Jankowski, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Collegium Medicum Nicolaus Copernicus University and Oncology Centre', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'city': 'Kielce', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Jacek Sadowski, M.D.', 'role': 'CONTACT'}, {'name': 'Jacek Sadowski, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Regional Oncological Centre', 'geoPoint': {'lat': 50.87033, 'lon': 20.62752}}, {'city': 'Krakow', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Piotr Richter, M.D.', 'role': 'CONTACT'}, {'name': 'Piotr Richter, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jagiellonian Medical University College', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lublin', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Małgorzata Jankiewicz, M.D.', 'role': 'CONTACT'}, {'name': 'Małgorzata Jankiewicz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. John's Cancer Center", 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Wroclaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Jolanta Szelachowska, M.D.', 'role': 'CONTACT'}, {'name': 'Jolanta Szelachowska, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Silesian Oncological Centre', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Zamość', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Marek Mazurek, M.D.', 'role': 'CONTACT'}, {'name': 'Marek Mazurek, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NU-MED Centre for Cancer Diagnosis and Treatment', 'geoPoint': {'lat': 50.72314, 'lon': 23.25196}}], 'centralContacts': [{'name': 'Krzysztof Bujko, M.D. PhD', 'role': 'CONTACT', 'email': 'Krzysztof.Bujko@coi.pl', 'phone': '+48601207466'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Sklodowska-Curie National Research Institute of Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Polish Society of Surgical Oncology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}