Distant Metastasis, Local Recurrence of Malignant Tumor of Rectum, Rectal Cancer, Adenocarcinoma, Rectal Cancer Stage II, Rectal Cancer Stage III
Conditions
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).
Interventions
PROCEDUREneoadjuvant treatment
We study the number of patients who achive a complete pathological response after neoadjuvant treatment with radiochemotherapy.
Sponsors
Hospital San Carlos, Madrid
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Operative and treatment data related to adverse oncologic outcomes. |
| To analyze demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths. | May 2022-June 2022 | Age (years) related to worse long-term oncologic outcomes. |
| 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 | Normal Pretreatment CEA (ng/dl) related to worse long-term oncologic 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 | Tumour location (cm) and Distance from anal verge (cm) related to worse long-term oncologic outcomes. |
Countries
Spain
Outcome results
None listed