Status:
UNKNOWN
Survival of Patients With a Reduction in the Number of Lymph Nodes in Rectal Cancer After Neoadjuvant Chemoradiotherapy
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
SERGIO CARLOS NAHAS
CAIO SERGIO NAHAS
Conditions:
Cancer of Rectum
Lymph Node Disease
Eligibility:
All Genders
18-80 years
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 res...
Detailed Description
According to the International Union Against Cancer a minimum of 12 lymph nodes (LN) should be obtained in the surgical specimen for colorectal cancer staging. Recent studies have reported that the us...
Eligibility Criteria
Inclusion
- Patients with a biopsy-proven mid and low rectal adenocarcinoma located within 10 cm from the anal verge, stage cT3-4N0M0 or cT (any)N + M0, and patients with low (\< 5 cm from anal verge) cT2N0 of distal rectum because of the risk of needing an abdominoperineal resection.
- \-
Exclusion
- Patients with synchronous colorectal cancer or other non-colorectal cancers, stage IV disease, rectal cancer in the setting of inflammatory bowel disease or familial adenomatous polyposis, palliative resections, previous pelvic radiotherapy, significant comorbidities that prevent curative surgical resection and/or CRT, concurrent participation in another research protocol involving therapeutic intervention
- \-
Key Trial Info
Start Date :
May 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 15 2021
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04456283
Start Date
May 20 2019
End Date
July 15 2021
Last Update
July 2 2020
Active Locations (1)
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1
Medicine School, Sao Paulo University
São Paulo, Brazil, 05403-900