Trials / Completed
CompletedNCT05495308
"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".
Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and pCR After Neoadjuvant Treatment.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 4 (actual)
- Sponsor
- Hospital San Carlos, Madrid · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | neoadjuvant treatment | We study the number of patients who achive a complete pathological response after neoadjuvant treatment with radiochemotherapy. |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2022-03-01
- Completion
- 2022-05-01
- First posted
- 2022-08-10
- Last updated
- 2022-08-10
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05495308. Inclusion in this directory is not an endorsement.