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

NCT07141147 | Not Yet Recruiting DMC

• 1 other identifier: 2025-FXY-098
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Adrenocortical carcinoma; Radiotherapy; Multicenter clinical

Outcome Measures

Primary Outcomes (1)

• 3-year local recurrence-free survival

  The percentage of the patients survive without local recurrence after a time period, from pathological diagnosis

  From a definitive pathological diagnosis to a 3-year follow-up

Secondary Outcomes (3)

• The incidence of grade 3/4 toxicities

  The whole period of postoperative adjuvant radiotherapy，an average of 6 weeks

• 3-year overall surviva

  From a definitive pathological diagnosis to a 3-year follow-up

• 3-year disease-free survival

  From a definitive pathological diagnosis to a 3-year follow-up

Study Arms (2)

Experimental group

EXPERIMENTAL

Postoperative Adjuvant Radiotherapy

Radiation: Radiation

Control group

NO INTERVENTION

Regular postoperative follow-up

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years and ≤ 75 years.
• ECOG performance status score ≤ 1, with an expected survival period ≥ 6 months.
• Completion of radical resection for adrenocortical carcinoma (ACC) with curative intent.
• Postoperative pathological diagnosis of adrenocortical carcinoma.
• Pathological stage is localized ACC: ENSAT stage 1-3; where ENSAT stage 3 is defined as any T stage (T1-4) with regional lymph node positivity, or tumor invasion into surrounding tissues/organs or the renal vein/inferior vena cava, but without distant metastasis.
• High-risk factors: Ki-67 index \>10%, ENSAT stage 3, positive resection margin, high pathological grade; the presence of any one of these factors qualifies.
• Postoperative imaging review prior to radiotherapy shows no evidence of residual or metastatic disease.

You may not qualify if:

• ENSAT Stage 4 adrenocortical carcinoma.
• Performance status: Karnofsky Performance Status (KPS) score ≤ 70 or Zubrod score \> 2.
• Prior radiotherapy to the abdomen or pelvis.
• Insufficient function of major organs (heart, lung, liver, kidney, bone marrow hematopoiesis) precluding tolerance to radiotherapy.
• Pregnant or lactating women, and subjects of childbearing potential unwilling to use contraception.
• Patients with psychiatric disorders, history of alcoholism or substance abuse, or those unable to provide informed consent.
• Other conditions deemed by the investigator to make the subject unsuitable for participation in this trial, including but not limited to: severe illnesses requiring immediate intervention (including psychiatric disorders), severely abnormal laboratory results, or other social or familial high-risk factors.
• Patients with other concurrent primary cancers; or patients diagnosed with another primary malignancy within the 5 years prior to the study (except for adequately treated carcinoma in situ of the cervix, or skin cancers such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Adrenocortical Carcinoma

Interventions

Radiation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Central Study Contacts

Hui Chang, MD

CONTACT

+8613480295989; changhui@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice Director of the Department of Radiation Oncology, Cancer Center

Model Details: This trial uses a simple randomized controlled design.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 26, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2030
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)