Status:
NOT_YET_RECRUITING
A Prospective, Randomized, Multicenter Clinical Study Comparing Adjuvant Radiotherapy Versus Observation in High-risk Localized Adrenocortical Carcinoma After Surgery.
Lead Sponsor:
Sun Yat-sen University
Conditions:
Radiotherapy
High-risk Localized Adrenocortical Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
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 lo...
Detailed Description
Adrenocortical Carcinoma (ACC) is an extremely rare and highly aggressive malignant tumor. Its incidence is 0.7-2 per million people, yet it carries a poor prognosis, with an overall 5-year survival r...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2030
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT07141147
Start Date
September 15 2025
End Date
September 30 2030
Last Update
September 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060