"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.
1 other identifier
observational
4
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 4, 2022
CompletedFirst Posted
Study publicly available on registry
August 10, 2022
CompletedAugust 10, 2022
August 1, 2022
6 months
August 4, 2022
August 8, 2022
Conditions
Outcome Measures
Primary Outcomes (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.
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 Outcomes (4)
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
To analyze demographic data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
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.
May 2022-June 2022
To analyze clinical data in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths.
May 2022-June 2022
Study Arms (2)
NON-DISTANT METASTASES
Those patiens who do not develop distant metastasis during the follow-up time.
DISTANT METASTASES
Those patiens who develop distant metastasis during the follow-up time.
Interventions
We study the number of patients who achive a complete pathological response after neoadjuvant treatment with radiochemotherapy.
Eligibility Criteria
Patients treated for LARC with nCRT and surgery (either TME or subtotal TME; S-TME) who had obtained a pCR
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital La Princesa
Madrid, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 80 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Colorectal Surgery Department at Hospital Universitario de la Princesa, Madrid. Spain. ORCID: 0000-0002-6507-900X
Study Record Dates
First Submitted
August 4, 2022
First Posted
August 10, 2022
Study Start
September 1, 2021
Primary Completion
March 1, 2022
Study Completion
May 1, 2022
Last Updated
August 10, 2022
Record last verified: 2022-08