Assessment of Efficacy of Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Assessment of Efficacy of New Adjuvant Therapy in Locally Advanced Rectal Cancer

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.

Study Overview

• Status: Completed
• Conditions: Locally Advanced Rectal Carcinoma

Detailed Description

Colorectal cancer ranks third in terms of global incidence (10.2%) and second in terms of mortality (9.2%) among malignant tumors, with rectal cancer accounting for one-third of cases. The standard treatment regimen for locally advanced rectal cancer (LARC), neoadjuvant chemotherapy (NACT) combined with total mesorectal excision (TME), has been shown to better control local disease, reduce local recurrence rates, but does not improve overall survival. In recent years, with the continuous improvement of surgical techniques, surgical treatment has also achieved better local control effects for locally advanced rectal cancer. However, the efficacy of neoadjuvant therapy varies greatly in different studies. For locally advanced rectal cancer, a prospective clinical study published in the New England Journal of Medicine in 2004 compared the efficacy differences between preoperative neoadjuvant chemoradiotherapy (NCRT) and postoperative chemoradiotherapy. The study demonstrated that compared to postoperative chemoradiotherapy, preoperative NCRT combined with total mesorectal excision could better control the local disease, reduce the toxicity of chemoradiotherapy, but did not help prolong overall survival. However, due to issues such as increased postoperative complications associated with neoadjuvant radiotherapy, some rectal cancer patients refuse neoadjuvant radiotherapy. Therefore, a significant amount of research has also been devoted to proving the efficacy of neoadjuvant chemotherapy alone.

Additionally, neoadjuvant therapy can also increase the rate of sphincter preservation for low rectal cancer. However, there is still controversy over whether neoadjuvant therapy can bring survival benefits to rectal cancer patients. How to reduce overtreatment caused by neoadjuvant therapy and related toxic side effects is also a current research hotspot. This study analyzed the efficacy differences between neoadjuvant therapy and direct surgical treatment in patients with locally high-risk rectal cancer in the real world, aiming to evaluate the impact of neoadjuvant therapy on overall survival, disease-free survival, and local recurrence-free survival in patients with locally high-risk rectal cancer, explore the high-benefit population of neoadjuvant therapy, and provide evidence-based medicine evidence for the benefits of neoadjuvant therapy in real-world rectal cancer patients.

• Study Type: Observational
• Enrollment (Actual): 3515

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Study Director: Zerong Cai, MD, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2010
• Primary Completion (Actual): December 6, 2018
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: March 9, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 2021ZSLYEC-192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Please contact us by e-mail

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No