Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment
Cancer of Rectum Lymph Node Disease Behavioral: Survival

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prospective Analysis of the Survival of Patients With a Reduction in the Number of Lymph Nodes in Rectal Cancer After Neoadjuvant Chemoradiotherapy
Actual Study Start Date : May 20, 2019
Actual Primary Completion Date : May 15, 2020
Estimated Study Completion Date : July 15, 2021

Group/Cohort Intervention/treatment
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
Behavioral: Survival
5 year survival after Chemoradiation theraphy for Rectal Cancer

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
Behavioral: Survival
5 year survival after Chemoradiation theraphy for Rectal Cancer

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
Behavioral: Survival
5 year survival after Chemoradiation theraphy for Rectal Cancer

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
Behavioral: Survival
5 year survival after Chemoradiation theraphy for Rectal Cancer




Primary Outcome Measures :
  1. 5 years Survival [ Time Frame: 5 years ]
    5 years Survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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.

-

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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456283


Locations
Layout table for location information
Brazil
Medicine School, Sao Paulo University Recruiting
Sao Paulo, Brazil, 05403-900
Contact: Leonardo A Bustamante, Surgeon    55 11 985000091    leo708@hotmail.com   
Principal Investigator: Leonardo A Bustamante L, MD         
Sponsors and Collaborators
University of Sao Paulo
SERGIO CARLOS NAHAS
CAIO SERGIO NAHAS
Ivan Cecconello
Ulysses Ribeiro Junior
Layout table for additonal information
Responsible Party: Leonardo Alfonso Bustamante, Post doctoral fellow, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04456283    
Other Study ID Numbers: 9076078
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases