Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:26 AM
Study NCT ID:
NCT07353567
Status:
COMPLETED
Last Update Posted:
2026-03-03
First Post:
2025-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Outcomes and Risk Factors of Local Re-Recurrence in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-28', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2026-01-18', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local re-recurrence free survival', 'timeFrame': 'LrRFS was calculated from the date of salvage radical surgery until the date when any local re-recurrence was detected by imaging or histology, or until censored at the last follow-up or death, assessed up to 180 months.]'}, {'measure': 'post-recurrent overall survival', 'timeFrame': 'PROS was calculated from the date of salvage radical surgery until the date of death or until censored at the last follow-up, assessed up to 180 months.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Local Re-Recurrence of Malignant Tumor of Rectum', 'Local Recurrence of Malignant Tumor of Rectum']}, 'descriptionModule': {'briefSummary': 'To analyze the long-term oncological outcome and identify independent risk factors for local re-recurrence in patients undergoing radical salvage surgery for locally recurrent rectal cancer.', 'detailedDescription': 'Locally recurrent rectal cancer (LRRC) occurs in 5-12% of rectal cancer patients following curative treatment and continues to pose a considerable clinical challenge1-6. At present, radical salvage surgery represents the only potentially curative approach, with 5-year overall survival (OS) rates of 40-55% reported in selected patient cohorts7-11. Despite advances in surgical techniques and systemic treatments, a significant proportion of patients still develops local re-recurrence (LrR) after salvage surgery for LRRC. In a cohort study with a 10 years of follow-up, 42% of LRRC patients undergoing radical surgery developed LrR, with a concomitant distant metastasis rate of 54.8%11, and another multicenter retrospective study reported a 33% rate of LrR12. Nevertheless, data regarding risk factors and the prognosis of LrR remains scarce.\n\nSeveral clinical factors associated with LrR has been reported, including positive resection margin and the administration of systemic or local treatments13-15. Furthermore, it remains unclear whether clinicopathological characteristics-from the primary tumor through to local recurrence-can predict the risk of re-recurrence after salvage radical resection.\n\nTherefore, this study aimed to investigate the incidence of LrR among LRRC patients who underwent radical salvage surgery at a high-volume tertiary center in China, and to identify independent prognostic factors associated with LrR. The results may contribute to improving postoperative surveillance and facilitating the development of individualized management strategies for LRRC patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 298 patients who underwent radical salvage surgery for LRRC were included in the study, from January 1st, 2010 to March 1st, 2025.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1). Patients had undergone curative-intent resection for a histologically confirmed primary rectal or rectosigmoid adenocarcinoma. A disease-free interval ≥1 months was required to distinguish subsequent local recurrence from persistent disease;\n* (2). LRRC located within the true pelvis or at the pelvic brim, confirmed by radiological imaging (e.g., MRI, CT, PET-CT) and/or pathological verification;\n* (3). Patients who underwent radical salvage surgery (R0/R1) for LRRC. No evidence of residual disease or early second recurrence was observed within 1 months after salvage surgery.\n* (4). Availability of complete clinicopathological and treatment-related data.\n\nExclusion Criteria:\n\n* (1). History of synchronous or metachronous other primary malignancies;\n* (2). R2 resection for LRRC;\n* (3). Presence of uncontrollable synchronous distant metastasis at the time of either primary tumor treatment or LRRC diagnosis;\n* (4). Patients lost to follow-up or lacking essential survival data.'}, 'identificationModule': {'nctId': 'NCT07353567', 'briefTitle': 'Long-term Outcomes and Risk Factors of Local Re-Recurrence in Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'officialTitle': 'Long-term Outcomes and Risk Factors of Local Re-Recurrence in Patients With Locally Recurrent Rectal Cancer', 'orgStudyIdInfo': {'id': '2025ZSLYEC-595'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients without local re-recurrence'}, {'label': 'patients with local re-recurrence'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Please contact us by Email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of the Department', 'investigatorFullName': 'Cai Zerong', 'investigatorAffiliation': 'Sixth Affiliated Hospital, Sun Yat-sen University'}}}}