"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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain
- Hospital La Princesa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
NON-DISTANT METASTASES
Those patiens who do not develop distant metastasis during the follow-up time.
|
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.
|
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.
Time Frame: May 2022-June 2022
|
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.
Time Frame: May 2022-June 2022
|
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.
Time Frame: May 2022-June 2022
|
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.
Time Frame: May 2022-June 2022
|
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.
Time Frame: May 2022-June 2022
|
Tumour location (cm) and Distance from anal verge (cm) related to worse long-term oncologic outcomes.
|
May 2022-June 2022
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C.I. 20/741-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.