Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05871567
Other study ID # Università Vanvitelli Napoli
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date March 31, 2023

Study information

Verified date May 2023
Source University of Campania "Luigi Vanvitelli"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

- Microsatellite instable (MSI) tumors represent almost the 15% of all sporadic colorectal cancers (CRCs). - Literature data show that this unique tumor population appears to be poorly responsive to conventional chemotherapy and conversely reveals excellent results to immunotherapy. - Our data, as demonstrated by propensity score-matched and win ratio analysis, show that there are no substantial differences between MSI and MSS tumors in early CRC stages treated with surgery alone. - On the contrary, stable tumors (MSS) did much better than MSI tumors in advanced CRC stages undergoing conventional adjuvant treatment. - Determination of status of DNA mismatch repair system is crucial in high-risk CRCs to optimize treatment.


Description:

Colorectal cancers (CRCs) with deficient DNA mismatch repair (MMR) system (so called dMMR or MSI tumors) represent a no-negligible part of sporadic CRCs. Prognostic value of this unique cell population remains controversial, but undoubtedly these tumors are characterized by poor response to conventional chemotherapy, an high tumor mutational burden resulting in a brisk immuno response, and, as recently observed, excellent results to the immunotherapy. The aim of this study was to evaluate, by using sophisticated statistical analyses, the predictive value of MSI status and its optimal treatment. A series of 403 consecutive CRC patients treated by the same oncological team from 2014 to 2021 entered the study. No patients underwent immunotherapy. Immunohistochemistry, integrated by polymerase chain reaction if appropriate, was used to categorize specimens in microsatellite stable (MSS) and instable (MSI) tumors. The win ratio (WR) approach was utilized to compare composite outcomes of MSS and MSI tumors while controlling for radical versus no radical resection, propensity score-matched analysis, and reversing primary endpoint.


Recruitment information / eligibility

Status Completed
Enrollment 403
Est. completion date March 31, 2023
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 86 Years
Eligibility Inclusion Criteria: - all consecutive CRC patients observed from January 2014 to December 2021 Exclusion Criteria: - Patients with suspected or confirmed Lynch's syndrome (12 patients) and rectal cancers (98 patients) undergoing neoadjuvant treatment

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
colorectal resection
potential resective surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli"

Outcome

Type Measure Description Time frame Safety issue
Primary survival rate overall survival "From date of surgical operation until the date of death from any cause assessed up to 60 months"
Secondary recurrence rate disease-free survival "From date of surgical operation until the date of documented tumor recurrence assessed up to 60 months"
See also
  Status Clinical Trial Phase
Recruiting NCT05429866 - Immunological Variables Associated to ICI Toxicity in Cancer Patients Phase 2
Active, not recruiting NCT03983993 - Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer Phase 2
Not yet recruiting NCT06006923 - Regorafenib in Combination With Pembrolizumab or Pembrolizumab for MSI-H Colorectal Cancer Phase 2
Recruiting NCT05714553 - NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours Phase 1/Phase 2
Not yet recruiting NCT05841134 - Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer Phase 2
Recruiting NCT06414304 - Dynamics of MSI and Genomic Profile of Colorectal Cancer In the Course of Immune Checkpoint Inhibitor Therapy
Active, not recruiting NCT04301557 - PD1 Antibody Toripalimab and Chemoradiotherapy for dMMR/MSI-H Locally Advanced Colorectal Cancer Phase 2
Terminated NCT04244552 - A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies Phase 1
Completed NCT04440943 - A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies Phase 1
Recruiting NCT04730544 - Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI mCRC. Phase 2
Recruiting NCT04802876 - Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors Phase 2