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NCT05495308

"Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and Pathologic Complete Response After Neoadjuvant Treatment. Results From an Observational Retrospective Multicenter Long-term Follow-up Study".

Completed Last updated 10 August 2022
What this trial tests

trial testing neoadjuvant treatment in Rectal Cancer, Adenocarcinoma in 4 participants. Completed in 1 May 2022.

Timeline
1 September 2021
Primary endpoint
1 March 2022
1 May 2022

Quick facts

Lead sponsorHospital San Carlos, Madrid
StatusCompleted
Study typeOBSERVATIONAL
Enrollment4
Start date1 September 2021
Primary completion1 March 2022
Estimated completion1 May 2022
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Hospital San Carlos, Madrid

Who can join

Adults 18 to 100, any sex, with Rectal Cancer, Adenocarcinoma or Rectal Cancer Stage II. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pathologic complete response (pCR) after multimodal treatment for locally advanced rectal cancer (LARC) patients is considered as the gold-standard of treatment success as it is associated to privileged oncologic outcome. Nevertheless, data from multicenter high-volume cohorts with long term follow-up are scarce. This is a multicenter observational study using prospectively collected data from the Spanish Rectal Cancer Project database. The main objective of the study is to update long-term oncologic follow-up of those patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR. Secondary objective is to analyze demographic, clinical, operative and treatment variables in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths. The results are reported in accordance with the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) Statement for observational studies. All calculations are performed using Stata 13.1 (StataCorp, Texas, USA).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Conditional Survival in Patients with Locally Advanced Rectal Cancer and Pathologic Complete Response: Results from an Observational Retrospective Multicenter Long-Term Follow-Up Study.
    Cerdán Santacruz C, Cano-Valderrama O, Fernández LM, Sanz-Ongil R, et al · · 2025 · PMID 40867336 · DOI 10.3390/cancers17162707

Verify or expand the search:

Other recruiting trials for Rectal Cancer, Adenocarcinoma

Currently open trials in the same condition.

Other Hospital San Carlos, Madrid trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05495308.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing