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

NCT07141147 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-09-03

No results posted yet for this study

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.

Conditions

  • Radiotherapy
  • High-risk Localized Adrenocortical Carcinoma

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-09-30
Completion
2030-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07141147 on ClinicalTrials.gov