MedTrace Logo

"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".

NCT05495308 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2022-08-10

No results posted yet for this study

Summary

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).

Conditions

  • Rectal Cancer, Adenocarcinoma
  • Rectal Cancer Stage II
  • Rectal Cancer Stage III
  • Distant Metastasis
  • Local Recurrence of Malignant Tumor of Rectum

Interventions

PROCEDURE

neoadjuvant treatment

We study the number of patients who achive a complete pathological response after neoadjuvant treatment with radiochemotherapy.

Sponsors & Collaborators

  • Hospital San Carlos, Madrid

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-03-01
Completion
2022-05-01

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05495308 on ClinicalTrials.gov