"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".

Completed

• Conditions: Rectal Cancer, Adenocarcinoma; Rectal Cancer Stage II; Rectal Cancer Stage III; Local Recurrence of Malignant Tumor of Rectum; Distant Metastasis
• Interventions: Procedure: neoadjuvant treatment

• Registration Number: NCT05495308
• Lead Sponsor: Hospital San Carlos, Madrid

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-05-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-10
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NON-DISTANT METASTASES	neoadjuvant treatment	Those patiens who do not develop distant metastasis during the follow-up time.
DISTANT METASTASES	neoadjuvant treatment	Those patiens who develop distant metastasis during the follow-up time.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 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 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.

Trial Locations

Locations (1)

Hospital La Princesa; 🇪🇸 Madrid, Spain