"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".

Rectal Cancer Stage III Clinical Trial

Official title:

Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and pCR After Neoadjuvant Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05495308
• Other study ID #: C.I. 20/741-E
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2022
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: May 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Local Recurrence of Malignant Tumor of Rectum
• Neoplasms
• Rectal Cancer Stage II
• Rectal Cancer Stage III
• Rectal Cancer, Adenocarcinoma
• Rectal Neoplasms
• Recurrence

Intervention

Procedure:
• neoadjuvant treatment
We study the number of patients who achive a complete pathological response after neoadjuvant treatment with radiochemotherapy.

Locations

Country	Name	City	State
Spain	Hospital La Princesa	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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