Skip to content

A prospective, randomized, controlled, multi-center clinical study of postoperative adjuvant radiotherapy for high-risk localized adrenocortical carcinoma

A prospective, randomized, controlled, multi-center clinical study of postoperative adjuvant radiotherapy for high-risk localized adrenocortical carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106325
Enrollment
Unknown
Registered
2025-07-22
Start date
2025-07-30
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adrenocortical carcinoma

Interventions

experimental group:Adjuvant Radiotherapy
control group:followed up regularly

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients voluntarily participated in this study and signed informed consent; 2. patients aged >=18 or =6 months; 4. complete radical adrenocortical carcinoma resection; 5. adrenal cortical carcinoma diagnosed by postoperative pathology; 6. pathological staging of localized adrenocortical carcinoma: ENSAT stage 1-3; Among them ENSAT stage 3 was defined as positive regional lymph nodes or tumor invasion regardless of T stage Invasion of surrounding tissues/organs or renal vein/inferior vena cava without distant metastasis; 7. High-risk factors: Ki-67%>10%, ENSAT stage 3, positive surgical margin, and high pathological grade, if one of these factors is present; 8. No residual or metastatic lesions were found by imaging examination before postoperative radiotherapy; 9. Subjects were willing to return to the hospital for follow-up with good compliance.

Exclusion criteria

Exclusion criteria: 1. ENSAT stage 4 adrenocortical carcinoma; 2. Karnofsky score 2; 3. previous local radiotherapy in the abdomen and pelvis; 4. Vital organ dysfunction (heart, lung, liver, kidney, bone marrow hematopoiesis), which can not tolerate radiotherapy; 5. pregnant or lactating women and those of childbearing age who are unwilling to use contraception; 6. persons with mental illness, history of alcohol or drug abuse, or inability to obtain informed consent; 7. those who were judged by other investigators to be not suitable for the trial, such as serious diseases including mental disorders requiring timely intervention, severe abnormal test results, and other social or family risk factors; 8. patients with other primary cancers; Patients with other primary malignancies (except adequately treated cervical cancer or skin cancer in situ, such as basal-cell carcinoma, squamous-cell carcinoma, or nonmelanoma skin cancer) within 5 years before the study.

Design outcomes

Primary

MeasureTime frame
3-year local recurrence-free survival;

Secondary

MeasureTime frame
3-year overall survival rate;3-year disease free survival rate;Incidence of 3/4 grade radiotherapy adverse reactions;

Countries

China

Contacts

Public ContactHui Chang

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong province

changhui@sysucc.org.cn+86 134 8029 5989

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026