"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.

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).

Study Overview

• Status: Completed
• Conditions: Rectal Cancer Stage II; Rectal Cancer Stage III; Rectal Cancer, Adenocarcinoma; Distant Metastasis; Local Recurrence of Malignant Tumor of Rectum
• Intervention / Treatment: Procedure: neoadjuvant treatment

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hospital La Princesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NON-DISTANT METASTASES; Those patiens who do not develop distant metastasis during the follow-up time.	Procedure: neoadjuvant treatment; We study the number of patients who achive a complete pathological response after neoadjuvant treatment with radiochemotherapy.
DISTANT METASTASES; Those patiens who develop distant metastasis during the follow-up time.	Procedure: neoadjuvant treatment; We study the number of patients who achive a complete pathological response after neoadjuvant treatment with radiochemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR.	May 2022-June 2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To analyze operative and treatment data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.	Operative and treatment data related to adverse oncologic outcomes.	May 2022-June 2022
To analyze demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.	Age (years) related to worse long-term oncologic outcomes.	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.	Normal Pretreatment CEA (ng/dl) related to worse long-term oncologic outcomes.	May 2022-June 2022
To analyze clinical data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.	Tumour location (cm) and Distance from anal verge (cm) related to worse long-term oncologic outcomes.	May 2022-June 2022

Collaborators and Investigators

• Sponsor: Hospital San Carlos, Madrid

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Neoplasms; Recurrence; Rectal Neoplasms
• Other Study ID Numbers: C.I. 20/741-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No