Clinical trial · Observational

Assessment of Efficacy of Neoadjuvant Therapy in Locally Advanced Rectal Cancer

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

NCT06314737CI-TRIAL-00075142completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Locally Advanced Rectal Carcinoma	Rectal Carcinoma	CURATED_BROADER	0.78

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (2)

label
Neoadjuvant therapy group
description
The primary tumor received neoadjuvant therapy before surgical treatment.
label
Surgical treatment group
description
The primary tumor did not receive neoadjuvant therapy before surgical treatment.

Primary outcomes (1)

measure
Overall Survival
timeFrame
From date of randomization until the date of death from any cause, assessed up to 120 months
description
Overall survival is defined as the time from the date of randomization to the date of death from any cause.

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

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.

References

Publications (1)

DERIVEDWang 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