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

Cancer of Rectum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04456283
• Other study ID #: 9076078
• Status: Recruiting
• Start date: May 20, 2019
• Est. completion date: July 15, 2021

Study information

• Verified date: June 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 15, 2021
• Est. primary completion date: May 15, 2020
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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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Related Conditions & MeSH terms

• Cancer of Rectum
• Lymph Node Disease
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Brazil	Medicine School, Sao Paulo University	Sao Paulo

Sponsors (5)

Lead Sponsor	Collaborator
University of Sao Paulo	CAIO SERGIO NAHAS, Ivan Cecconello, SERGIO CARLOS NAHAS, Ulysses Ribeiro Junior

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5 years Survival	5 years Survival	5 years