Survival of Patients With a Reduction in the Number of Lymph Nodes in Rectal Cancer After Neoadjuvant Chemoradiotherapy
Prospective Analysis of the Survival of Patients With a Reduction in the Number of Lymph Nodes in Rectal Cancer After Neoadjuvant Chemoradiotherapy
1 other identifier
observational
250
1 country
1
Brief Summary
Objective: To analyze the survival of patients with a reduction in the number of resected LN in patients submitted to neoadjuvant and total excision of the mesorectum with rectal cancer. Expected results: Survival rate between patients Complete Pathologic Response with less than 12 LN and 12 or more LN. To determine the difference in survival between patients with less than 12 LN in complete versus incomplete response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2020
CompletedFirst Submitted
Initial submission to the registry
June 28, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2021
CompletedJuly 2, 2020
June 1, 2020
12 months
June 28, 2020
June 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
5 years Survival
5 years Survival
5 years
Study Arms (4)
Incomplete pathological response with less than 12 LN.
Patients with incomplete pathological response after Chemoradiation theraphy for Rectal Cancer and less than 12 lymph nodes
Incomplete pathological response with 12 or more LN.
Patients with incomplete pathological response after Chemoradiation theraphy for Rectal Cancer and 12 lymph or more nodes
Complete pathological response with less than 12 LN.
Patients with complete pathological response after Chemoradiation theraphy for Rectal Cancer and less than 12 lymph nodes
Complete pathological response with 12 or more LN.
Patients with complete pathological response after Chemoradiation theraphy for Rectal Cancer and 12 lymph or more nodes
Interventions
5 year survival after Chemoradiation theraphy for Rectal Cancer
Eligibility Criteria
Patients with mid and low rectal cancer within 10 cm from the anal verge, stage cT3-4N0M0 or cT (any)N + M0
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulolead
- SERGIO CARLOS NAHAScollaborator
- CAIO SERGIO NAHAScollaborator
- Ivan Cecconellocollaborator
- Ulysses Ribeiro Juniorcollaborator
Study Sites (1)
Medicine School, Sao Paulo University
São Paulo, 05403-900, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Post doctoral fellow
Study Record Dates
First Submitted
June 28, 2020
First Posted
July 2, 2020
Study Start
May 20, 2019
Primary Completion
May 15, 2020
Study Completion
July 15, 2021
Last Updated
July 2, 2020
Record last verified: 2020-06