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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. 5 years Survival [ Time Frame: 5 years ]
   5 years Survival

Eligibility Criteria

• 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.

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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

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Contacts and Locations

Locations

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

More 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
• Last Update Posted: July 2, 2020
• Last Verified: June 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant 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