Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
243 participants
OBSERVATIONAL
2012-01-01
2023-03-31
Brief Summary
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Detailed Description
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It has been proposed to add TD count to the number of metastatic lymph nodes or to consider TDs as distant metastases, but the scientific basis of these proposals seems dubious and not supported by robust statistical analyses.
The investigators supposed that splitting the three sub-stages of the stage III CRC according to absence or presence of TDs could be an easy and useful method to avoid the loss of crucial information. The proposed study will include 243 stage III CRC patients undergoing radical surgery and adjuvant chemotherapy. Each new substage, according to absence or presence of tumor deposits, will be analyzed with sophisticated statistical analysis (particularly the area-under-curve (AUC), calculated by the time-dependent receiver-operating-characteristic (ROC) curve for censored survival data) to individuate if this new staging does better the current one.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Tumor Deposits
Colorectal cancers with and without tumor deposits, undergoing curative surgery and adjuvant chemotherapy
Colorectal Resection
Radical resection of colorectal cancer
Interventions
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Colorectal Resection
Radical resection of colorectal cancer
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Rectal Cancer undergoing neoadjuvant (radio)chemotherapy
* colorectal cancers without metastatic nodes
* metastatic colorectal cancers
* eligible patients refusing adjuvant chemotherapy
ALL
No
Sponsors
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University of Campania Luigi Vanvitelli
OTHER
Responsible Party
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Gennaro Galizia
Full Professor of Surgery
Principal Investigators
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Gennaro Galizia, MD
Role: PRINCIPAL_INVESTIGATOR
University of Campania 'Luigi Vanvitelli'
References
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Galizia G, Lieto E, Auricchio A, Cardella F, Mabilia A, Podzemny V, Castellano P, Orditura M, Napolitano V. Naples Prognostic Score, Based on Nutritional and Inflammatory Status, is an Independent Predictor of Long-term Outcome in Patients Undergoing Surgery for Colorectal Cancer. Dis Colon Rectum. 2017 Dec;60(12):1273-1284. doi: 10.1097/DCR.0000000000000961.
Cervantes A, Adam R, Rosello S, Arnold D, Normanno N, Taieb J, Seligmann J, De Baere T, Osterlund P, Yoshino T, Martinelli E; ESMO Guidelines Committee. Electronic address: [email protected]. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Jan;34(1):10-32. doi: 10.1016/j.annonc.2022.10.003. Epub 2022 Oct 25. No abstract available.
Pyo DH, Kim SH, Ha SY, Yun SH, Cho YB, Huh JW, Park YA, Shin JK, Lee WY, Kim HC. Revised Nodal Staging Integrating Tumor Deposit Counts With Positive Lymph Nodes in Patients With Stage III Colon Cancer. Ann Surg. 2023 Apr 1;277(4):e825-e831. doi: 10.1097/SLA.0000000000005355. Epub 2021 Dec 23.
Khan H, Radomski SN, Siddiqi A, Zhou N, Paneitz DC, Johnston FM, Greer JB. Tumor deposits are associated with a higher risk of peritoneal disease in non-metastatic colorectal cancer patients. J Surg Oncol. 2023 May;127(6):975-982. doi: 10.1002/jso.27207. Epub 2023 Feb 15.
Lieto E, Auricchio A, Ronchi A, Del Sorbo G, Panarese I, Ferraraccio F, De Vita F, Galizia G, Cardella F. Presence of tumor deposits is a strong indicator of poor outcome in patients with stage III colorectal cancers undergoing radical surgery. J Gastrointest Surg. 2024 Jan;28(1):47-56. doi: 10.1016/j.gassur.2023.11.003.
Other Identifiers
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Vanvitelli Naples
Identifier Type: -
Identifier Source: org_study_id