Assessment of Efficacy of Neoadjuvant Therapy in Locally Advanced Rectal Cancer

NCT06314737 | Completed

• 1 other identifier: 2021ZSLYEC-192
• Study Type: observational
• Target: 3,515
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study analyzed the efficacy differences between neoadjuvant therapy and direct surgical treatment in patients with locally advanced rectal cancer in the real world. The aim was to evaluate the impact of neoadjuvant therapy on overall survival, disease-free survival, and local recurrence-free survival in patients with locally advanced rectal cancer, explore the population benefiting most from neoadjuvant therapy, and provide evidence-based medicine for the benefits of neoadjuvant therapy in patients with colorectal cancer in the real world.

Conditions

Locally Advanced Rectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival is defined as the time from the date of randomization to the date of death from any cause.

  From date of randomization until the date of death from any cause, assessed up to 120 months

Study Arms (2)

Neoadjuvant therapy group

The primary tumor received neoadjuvant therapy before surgical treatment.

Surgical treatment group

The primary tumor did not receive neoadjuvant therapy before surgical treatment.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who visited the Sixth Affiliated Hospital of Sun Yat-sen University between October 2010 and December 2018, were diagnosed with primary rectal adenocarcinoma based on initial pathological examination, and were diagnosed as T3-4 or N+ based on pelvic MRI or abdominal-pelvic CT scan. Their distance from the tumor lower margin to the anal verge was ≤12cm, and they subsequently underwent surgical treatment.

You may qualify if:

• Pathological examination confirmed primary rectal adenocarcinoma;
• Pelvic MRI or abdominal-pelvic CT at initial diagnosis diagnosed as T3-4 or N+;
• Thoracoabdominal CT indicated no evidence of distant metastasis;
• Distance from the tumor lower margin to the anal verge ≤12cm;
• Underwent surgical treatment.

You may not qualify if:

• Concurrently diagnosed with multiple colorectal cancers or concomitant other malignant tumors;
• Locally recurrent rectal cancer;
• Initial diagnosis suggests suspicious distant metastasis;
• Histological diagnosis of rectal squamous cell carcinoma, adenocarcinoma, or neuroendocrine carcinoma;
• MRI information lost;
• Did not undergo surgical treatment;
• Upper rectal cancer or cancer at the rectosigmoid junction.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Related Publications (1)

• Wang Z, Bai F, Chen Y, Liu X, Huang Z, Zhu Q, Wu X, Cai Z. Does the initial treatment of primary tumor impact prognosis after recurrence in locally advanced rectal cancer? Results from a retrospective cohort analysis. Int J Colorectal Dis. 2024 Sep 28;39(1):153. doi: 10.1007/s00384-024-04721-9.

  PMID: 39333450 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

The pathological specimens before operation and the specimens after operation

Study Officials

• Zerong Cai, MD

  Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 18, 2024
• Study Start: October 2, 2010
• Primary Completion: December 6, 2018
• Study Completion: January 1, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share