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NOT YET RECRUITING
NCT07141147
NA

A Prospective, Randomized, Multicenter Clinical Study Comparing Adjuvant Radiotherapy Versus Observation in High-risk Localized Adrenocortical Carcinoma After Surgery.

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This study is a prospective, randomized, controlled, multicenter clinical trial designed to evaluate whether adjuvant radiotherapy can improve the 3-year recurrence-free survival (RFS) in high-risk localized adrenocortical carcinoma (ACC) patients after radical resection. According to the inclusion and exclusion criteria of the study protocol, 58patients with high-risk localized ACC who underwent radical resection were enrolled and randomly divided into two groups: the control group (Group A), which received regular postoperative follow-up without intervention, and the study group (Group B), which received adjuvant radiotherapy after surgery. The study compared the 3-year RFS and 3-year overall survival (OS) between the two groups and assessed the incidence of grade 3/4 radiotherapy-related adverse reactions, aiming to further clarify the efficacy and safety of postoperative adjuvant radiotherapy.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2025-09-15

Completion Date

2030-09-30

Last Updated

2025-09-03

Healthy Volunteers

No

Interventions

RADIATION

Radiation

1. Technique:Linear accelerator with volumetric modulated arc therapy for irradiation. 2. Target Volume Delineation (Two-phase irradiation): Clinical Target Volume 1 (CTV1):Encompasses tumor bed (preoperative MRI/CT-defined ACC extent) + regional lymphatics (ipsilateral para-aortic nodes). Clinical Target Volume 2 (CTV2):Tumor bed only (preoperative MRI/CT-defined ACC extent). Planning Target Volume (PTV):PTV1: CTV1 + 0.6 cm margin.PTV2: CTV2 + 0.6 cm margin. 4.Organs at Risk (OARs):Stomach, liver, bilateral kidneys, pancreas, spinal cord, and bowel/colon within radiation fields. 5.Prescription Dose: Phase 1: PTV1 → 45 Gy in 25 fractions (1.8 Gy/fraction), 5 fractions/week. Phase 2: PTV2 → 10 Gy in 5 fractions (2.0 Gy/fraction), 5 fractions/week.

Locations (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China