Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and pCR After Neoadjuvant Treatment.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Cancer, Adenocarcinoma
- Sponsor
- Hospital San Carlos, Madrid
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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).
Investigators
Carlos Cerdán Santacruz
Colorectal Surgery Department at Hospital Universitario de la Princesa, Madrid. Spain. ORCID: 0000-0002-6507-900X
Hospital San Carlos, Madrid
Eligibility Criteria
Inclusion Criteria
- •Patients with pathological confirmation of rectal cancer preoperatively, in any of its histological variants.
- •Tumor located less than 12 cm from the anal margin.
- •Radiological stage II or III (cT3-4 N0 and/or any T with positive cN).
- •Neoadjuvant treatment with radio-chemotherapy.
- •Radical surgery performed on a scheduled basis and with curative intent.
- •Definitive pathology study with complete tumor regression.
Exclusion Criteria
- •Patients operated on with palliative intent.
- •Patients diagnosed with a hereditary colorectal cancer syndrome.
- •Patients who presented synchronous metastases at the time of diagnosis, or concurrent malignancy of another origin.
- •Patients who underwent emergency surgery.
Outcomes
Primary Outcomes
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.
Time Frame: May 2022-June 2022
Patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.
Secondary Outcomes
- To analyze clinical data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.(May 2022-June 2022)
- To analyze demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.(May 2022-June 2022)
- To analyze operative and treatment data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.(May 2022-June 2022)
- To analyze further demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.(May 2022-June 2022)