Clinical trial NCT05923450: Tumor Deposits in Colorectal Cancers
Official title: Presence of Tumor Deposits is a Strong Indicator of Poor Outcome in Stage III Colorectal Cancers Undergoing Radical Surgery: Need for an Urgent Revision of the Staging System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extranodal Extension
Keywords: tumor deposits
colorectal cancers
TNM staging system
ROC Curve
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 243
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: colorectal cancer patients with metastatic nodes undergoing radical surgery and adjuvant chemotherapy

Brief summary: Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs), but they are quite ignored in the current staging system. Previous proposals to incorporate TDs in node stage or consider them distant metastases raised some doubt. The Authors propose a new staging system to optimize treatments.

Detailed description: Tumor deposits (TDs) are emerging as an adverse prognostic factor in colorectal cancers (CRCs).In the current staging system TDs are somewhat neglected.

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.

Eligibility criteria: Inclusion Criteria:

* colorectal cancers in stage III TNM undergoing radical surgery and adjuvant chemotherapy

Exclusion Criteria:

* Lynch syndrome
* Rectal Cancer undergoing neoadjuvant (radio)chemotherapy
* colorectal cancers without metastatic nodes
* metastatic colorectal cancers
* eligible patients refusing adjuvant chemotherapy

Primary outcomes:
measure: Overall Survival
timeFrame: 5 years
measure: Disease-free Survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Campania 'Luigi Vanvitelli'
name: Gennaro Galizia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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: clinicalguidelines@esmo.org. 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.
citation: 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.
citation: 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.