Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-02 @ 6:36 AM
Study NCT ID:
NCT00939666
Status:
COMPLETED
Last Update Posted:
2017-03-24
First Post:
2009-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimal Invasive Strategies for Good and Complete Response to Chemoradiation in 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2009-07-14', 'studyFirstSubmitQcDate': '2009-07-14', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local recurrence', 'timeFrame': '2 and 5 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 and 5 years'}, {'measure': 'Disease-free survival', 'timeFrame': '2 and 5 years'}, {'measure': 'Distant metastasis-free survival', 'timeFrame': '2 and 5 years'}, {'measure': 'Quality of life', 'timeFrame': '6 weeks to 1 year'}, {'measure': 'Compliance', 'timeFrame': '2 and 5 years'}, {'measure': 'Percentage of patients that chooses the minimal invasive strategies over standard surgery', 'timeFrame': '2-5 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectal cancer', 'Chemoradiation', 'Response', 'Wait-and-see policy', 'Transanal endoscopic microsurgery'], 'conditions': ['Locally Advanced Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '22067400', 'type': 'RESULT', 'citation': 'Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewe KW, Buijsen J, Beets GL. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011 Dec 10;29(35):4633-40. doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7.'}, {'pmid': '33725387', 'type': 'DERIVED', 'citation': 'Haak HE, Zmuc J, Lambregts DMJ, Beets-Tan RGH, Melenhorst J, Beets GL, Maas M; Dutch Watch-and-Wait Consortium. The evaluation of follow-up strategies of watch-and-wait patients with a complete response after neoadjuvant therapy in rectal cancer. Colorectal Dis. 2021 Jul;23(7):1785-1792. doi: 10.1111/codi.15636. Epub 2021 Apr 2.'}]}, 'descriptionModule': {'briefSummary': "The high proportion of complete and good responders with modern chemoradiation and the improvement in magnetic resonance (MR)-imaging techniques have stimulated a renewed interest to the question whether in patients with complete or good response the overall benefits of a 'wait-and-see policy' or transanal endoscopic microsurgery (TEM) combined with intensive follow-up may outweigh the benefits associated with conventional surgery (total mesorectal excision (TME)or abdominoperineal resection (APR)). On the one hand, less invasive strategies will expose subjects to more diagnostic procedures and possibly a slightly higher risk of local failure and the need for salvage surgery. On the other hand, mortality and morbidity associated with radical surgery (e.g. anastomotic leakage, relaparotomy, wound and pelvic infection, chronic wound healing disturbances, abscess, colostomy, faecal or urinary incontinence and sexual dysfunction) can be avoided. The investigators believe that wait-and-see policy for complete responders and TEM for good responders after chemoradiation is a feasible alternative to standard surgery, provided these patients are intensively followed.", 'detailedDescription': "The high proportion of complete and good responders with modern chemoradiation and the improvement in magnetic resonance (MR)-imaging techniques have stimulated a renewed interest to the question whether in patients with complete or good response the overall benefits of a 'wait-and-see policy' or transanal endoscopic microsurgery (TEM) combined with intensive follow-up may outweigh the benefits associated with conventional surgery (total mesorectal excision (TME) or abdominoperineal resection (APR)). On the one hand, less invasive strategies will expose subjects to more diagnostic procedures and possibly a slightly higher risk of local failure and the need for salvage surgery. On the other hand, mortality and morbidity associated with radical surgery (e.g. anastomotic leakage, relaparotomy, wound and pelvic infection, chronic wound healing disturbances, abscess, colostomy, faecal or urinary incontinence and sexual dysfunction) can be avoided. The investigators believe that wait-and-see policy for complete responders and TEM for good responders after chemoradiation is a feasible alternative to standard surgery, provided these patients are intensively followed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older\n* Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response: Clinical complete response (ycT0N0) or very good response (ycT1-2N0) after pre-operative chemoradiation will be determined clinically (digital rectal examination, endoscopy), radiologically (contrast-enhanced-MRI) and pathologically (biopsy)\n* Informed consent and capability of giving informed consent\n* Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient (in other words that the patient understands the experimental base of the study).\n\nExclusion Criteria:\n\n* Recurrent rectal cancer.\n* Distant metastasis.\n* Unable or unwilling to comply to the intensive follow-up schedule.\n* Contra-indications for MRI. If MRI is not possible because of contra-indications (e.g. pacemaker) we will exclude patients. MRI is crucial for response evaluation and follow-up and can not be omitted in patients that follow the alternative strategies ('wait-and-see policy' or TEM)."}, 'identificationModule': {'nctId': 'NCT00939666', 'briefTitle': 'Minimal Invasive Strategies for Good and Complete Response to Chemoradiation in Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Minimal Invasive Treatment for Patients With Good Response to Chemoradiation With Selection and Follow-up by MRI: a Single Arm Phase-II Feasibility Study in Rectal Cancer', 'orgStudyIdInfo': {'id': 'MEC 09-2-034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wait&see or TEM with intensive follow-up', 'description': 'All patients will be included in this arm', 'interventionNames': ['Procedure: Wait&see or TEM with intensive follow-up']}], 'interventions': [{'name': 'Wait&see or TEM with intensive follow-up', 'type': 'PROCEDURE', 'description': 'Wait\\&see or TEM with intensive follow-up', 'armGroupLabels': ['Wait&see or TEM with intensive follow-up']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Roermond', 'country': 'Netherlands', 'facility': 'Laurentius Hospital Roermond', 'geoPoint': {'lat': 51.19417, 'lon': 5.9875}}], 'overallOfficials': [{'name': 'Geerard L Beets, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center, Maastricht, The Netherlands'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Pooling of data is expected in the future'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}