Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-01 @ 3:20 AM
Study NCT ID:
NCT03431428
Status:
UNKNOWN
Last Update Posted:
2018-02-13
First Post:
2018-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients
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': 'D000067368', 'term': 'Transanal Endoscopic Surgery'}], 'ancestors': [{'id': 'D057605', 'term': 'Natural Orifice Endoscopic Surgery'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011351', 'term': 'Proctoscopy'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 477}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-10', 'studyFirstSubmitDate': '2018-01-13', 'studyFirstSubmitQcDate': '2018-02-10', 'lastUpdatePostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'three years', 'description': 'The progression-free survival of 3 years'}, {'measure': 'OS', 'timeFrame': 'three years', 'description': '3 years of overall survival time'}], 'secondaryOutcomes': [{'measure': 'carcinoembryonic antigen（CEA）', 'timeFrame': 'every 3 months,for 2 years', 'description': 'The level of carcinoembryonic antigen in blood'}, {'measure': 'carbohydrate antigen 19-9（CA-199）', 'timeFrame': 'every 3 months,for 2 years', 'description': 'The level of carbohydrate antigen 19-9 in blood'}, {'measure': 'International Index of Erectile Function-15', 'timeFrame': 'every 3 months ,for 2 years', 'description': 'Describe the function of Erectile ,only for male patients'}, {'measure': 'International prostate symptom score', 'timeFrame': 'every 3 months ,for 2 years', 'description': 'Describe the function of prostate,only for male patients'}, {'measure': 'Female sexual function index', 'timeFrame': 'every 3 months,for 2 years', 'description': 'Describe the function of sexual for female patients'}, {'measure': 'Wexner incontinence score', 'timeFrame': 'every 3 months,for 2 years', 'description': 'Describe the degree of Anus incontinence'}, {'measure': 'QOL', 'timeFrame': 'every 3 months,for 2 years', 'description': 'Describe the quality of life for tumor patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Almost-cCR', 'Surgery', 'Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '37310167', 'type': 'DERIVED', 'citation': 'Motamedi MAK, Mak NT, Brown CJ, Raval MJ, Karimuddin AA, Giustini D, Phang PT. Local versus radical surgery for early rectal cancer with or without neoadjuvant or adjuvant therapy. Cochrane Database Syst Rev. 2023 Jun 13;6(6):CD002198. doi: 10.1002/14651858.CD002198.pub3.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is evaluate the effect of two different surgical treatment on lower rectal cancer after almost clinical complete response(almost-cCR). All almost clinical complete response(almost-cCRs) were entered into two groups randomly. The estimated sample size of the minimal operation group was 221, and 221 in the Mile's group. Three years' progression-free survival(PFS) and overall survival(OS) were compared.", 'detailedDescription': 'Patients with low rectal cancer were treated with neoadjuvant radiotherapy, and two cycles of XELOX at the interval. All almost-cCRs after neoadjuvant treatment were randomly divided into minimal operation group or Mile\'s group. All cCRs were treated with "watch and wait". Patients after local recurrence were randomly divided into minimal operation group or Mile\'s group. If pathological result was pathological staging 3 after neoadjuvant therapy（ypT3） in minimal operation group or local postoperative recurrence occurred, patients need supplement of abdominoperineal resection (APR). With 3 years follow-up，the main research goals are 3 years of progression-free survival(PFS) and overall survival(OS). Secondary endpoints are side effects of chemotherapy, assessment of quality of life, surgical complications, adverse prognostic factors and so on.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histology is confirmed as rectal adenocarcinoma.\n2. 18 to 75 years old.\n3. Preoperative staging is lower than clinical stage primary tumor grade 3, regional lymph node grade 1, and metastasis was grade 0（cT3cN1M0）.\n4. The anus couldn't be retained after TME.\n5. Almost-cCR or cCR recurrence during observation.\n\nExclusion Criteria:\n\n1. Patients were unable to tolerate the operation.\n2. Preoperative stage: T4b or progress during the treatment.\n3. HIV infection stage or chronic hepatitis B.\n4. Active clinical severe infections.\n5. Evil liquid state or decompensation of organ function.\n6. Other malignant tumor history in five years.\n7. Other primary carcinoma.\n8. Unstable condition and incompliance of the patient"}, 'identificationModule': {'nctId': 'NCT03431428', 'briefTitle': 'Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Liaoning Cancer Hospital & Institute'}, 'officialTitle': 'Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients: A Case-matched Study', 'orgStudyIdInfo': {'id': '20171112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'transanal surgery', 'description': 'To ensure the complete cutting edge with no residual tumor, the tumor with corresponding mesorectal excision was removed by the distance edge of 1cm.\n\nThe intestinal wall was sutured to ensure the integrity of the bowel.', 'interventionNames': ['Procedure: transanal surgery', 'Drug: Preoperative chemoradiotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Miles surgery', 'description': 'According to the total mesorectal excision(TME) principle, complete mesorectum, lymph node and the anus was excised. A sigmoid colostomy was finally performed.', 'interventionNames': ['Procedure: Miles surgery', 'Drug: Preoperative chemoradiotherapy']}], 'interventions': [{'name': 'transanal surgery', 'type': 'PROCEDURE', 'description': 'Transanal surgery could Preserve anus to reduce trauma and improve the quality of life', 'armGroupLabels': ['transanal surgery']}, {'name': 'Miles surgery', 'type': 'PROCEDURE', 'description': 'Miles surgery cut off the anus, enlarge the trauma and reduce the quality of life.', 'armGroupLabels': ['Miles surgery']}, {'name': 'Preoperative chemoradiotherapy', 'type': 'DRUG', 'description': 'After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.', 'armGroupLabels': ['Miles surgery', 'transanal surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rui Zhang, doctor', 'role': 'CONTACT', 'email': 'zzzrrr1234@sina.com', 'phone': '13898872185'}], 'facility': 'Liaoning cancer Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'rui zhang, doctor', 'role': 'CONTACT', 'email': 'zzzrrr1234@sina.com', 'phone': '8613898872185'}, {'name': 'xin liu, master', 'role': 'CONTACT', 'email': 'liuxin5626855@sina.com', 'phone': '8618900918981'}], 'overallOfficials': [{'name': 'peirong ding, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}, {'name': 'ji zhu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}, {'name': 'zhenning wang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Hospital of China Medical University'}, {'name': 'hong zhang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shengjing Hospital'}, {'name': 'yu han, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Affiliated Hospital of Harbin Medical University'}, {'name': 'zhaocheng chi, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jilin Provincial Tumor Hospital'}, {'name': 'quan wang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Bethune Hospital of Jilin University'}, {'name': 'ge liu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Dalian Medical University'}, {'name': 'hang lu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jinzhou Medical University'}, {'name': 'zheng liu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, {'name': 'rui Zhang, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Liaoning Cancer Hospital & Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhang Rui', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of colorectal surgery,clinical professor', 'investigatorFullName': 'Zhang Rui', 'investigatorAffiliation': 'Liaoning Cancer Hospital & Institute'}}}}