"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".

• Sponsor: Hospital San Carlos, Madrid (Other)
• Overall Status: Completed
• CT.gov ID: NCT05495308
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Actual Duration (Months): 8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer, Adenocarcinoma; Rectal Cancer Stage II; Rectal Cancer Stage III; Distant Metastasis; Local Recurrence of Malignant Tumor of Rectum	Procedure: neoadjuvant treatment

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 4 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Oncologic Results and Risk Factors for Recurrence in Patients With Locally Advanced Rectal Cancer and pCR After Neoadjuvant Treatment.
• Actual Study Start Date: Sep 1, 2021
• Actual Primary Completion Date: Mar 1, 2022
• Actual Study Completion Date: May 1, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital La Princesa	Madrid		Spain

Sponsors and Collaborators

• Hospital San Carlos, Madrid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carlos Cerdán Santacruz, Colorectal Surgery Department at Hospital Universitario de la Princesa, Madrid. Spain. ORCID: 0000-0002-6507-900X, Hospital San Carlos, Madrid
• ClinicalTrials.gov Identifier: NCT05495308
• Other Study ID Numbers: C.I. 20/741-E
• First Posted: Aug 10, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rectal Neoplasms; Neoplasms; Recurrence

Study Results

No Results Posted as of Aug 10, 2022