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Trial record 2 of 5 for:    Leonardo Alfonso Bustamante

Survival of Patients With a Reduction in the Number of Lymph Nodes in Rectal Cancer After Neoadjuvant Chemoradiotherapy

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ClinicalTrials.gov Identifier: NCT04456283
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborators:
SERGIO CARLOS NAHAS
CAIO SERGIO NAHAS
Ivan Cecconello
Ulysses Ribeiro Junior
Information provided by (Responsible Party):
Leonardo Alfonso Bustamante, University of Sao Paulo

Tracking Information
First Submitted Date June 28, 2020
First Posted Date July 2, 2020
Last Update Posted Date July 2, 2020
Actual Study Start Date May 20, 2019
Actual Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 28, 2020)
5 years Survival [ Time Frame: 5 years ]
5 years Survival
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Survival of Patients With a Reduction in the Number of Lymph Nodes in Rectal Cancer After Neoadjuvant Chemoradiotherapy
Official Title Prospective Analysis of the Survival of Patients With a Reduction in the Number of Lymph Nodes in Rectal Cancer After Neoadjuvant Chemoradiotherapy
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.

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 use of neoadjuvant chemoradiotherapy (QRN) may result in failure to obtain the minimum number of LN in the piece in 30-52% of patients. 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. Patients and methods: From January 2013 to January 2015, patients with rectal cancer were submitted to QRN (5-FU and 5040 Gys) followed by total excision of mesorectum with ligation of the inferior mesenteric vessels in their roots. Patients with T3, T4 and / or N + staging that were up to 10 cm from the anal border were included. Patients whose treatment with neoadjuvant chemoradiotherapy was incomplete or who had significant delays in re- staging and / or performing the surgery were excluded. All were staged by rectal examination, colonoscopy, chest and abdominal CT, and pelvic MRI, and also re-staged 8 weeks after neoadjuvant termination, operated and submitted to total excision of the mesorectum. The patients were divided into 4 groups: a) Incomplete pathological response with less than 12 LN. b) Incomplete pathological response with 12 or more LN. c) Complete pathological response with less than 12 LN. d) Complete pathological response with 12 or more LN. The possible variables related to the number of LN obtained and related to general and disease free survival were studied.

Expected results:

To analyze the 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. Demonstrate that patients with complete pathologic response and less than 12 LN have a disease-free survival equal to or better than patients with 12 LN or more.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with mid and low rectal cancer within 10 cm from the anal verge, stage cT3-4N0M0 or cT (any)N + M0
Condition
  • Cancer of Rectum
  • Lymph Node Disease
Intervention Behavioral: Survival
5 year survival after Chemoradiation theraphy for Rectal Cancer
Study Groups/Cohorts
  • 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
    Intervention: Behavioral: Survival
  • 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
    Intervention: Behavioral: Survival
  • 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
    Intervention: Behavioral: Survival
  • 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
    Intervention: Behavioral: Survival
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 28, 2020)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 15, 2021
Actual Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria: 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.

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Exclusion Criteria: 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

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT04456283
Other Study ID Numbers 9076078
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Leonardo Alfonso Bustamante, University of Sao Paulo
Study Sponsor University of Sao Paulo
Collaborators
  • SERGIO CARLOS NAHAS
  • CAIO SERGIO NAHAS
  • Ivan Cecconello
  • Ulysses Ribeiro Junior
Investigators Not Provided
PRS Account University of Sao Paulo
Verification Date June 2020