Clinical trial 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".
Official title: Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and pCR After Neoadjuvant Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer, Adenocarcinoma
Rectal Cancer Stage II
Rectal Cancer Stage III
Distant Metastasis
Local Recurrence of Malignant Tumor of Rectum
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR

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).


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.

Primary outcomes:
measure: 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.
timeFrame: May 2022-June 2022
Secondary outcomes:
measure: To analyze operative and treatment data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
timeFrame: May 2022-June 2022
measure: To analyze demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
timeFrame: May 2022-June 2022
measure: To analyze further demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
timeFrame: May 2022-June 2022
measure: To analyze clinical data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
timeFrame: May 2022-June 2022
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital La Princesa
Study officials:
References: