Clinical trial · Interventional
A Prospective, Randomized, Multicenter Clinical Study Comparing Adjuvant Radiotherapy Versus Observation in High-risk Localized Adrenocortical Carcinoma After Surgery.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-risk Localized Adrenocortical Carcinoma | Adrenal Cortical Carcinoma | PROBABILISTIC | 0.70 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Postoperative Adjuvant Radiotherapy
- interventionNames
- Radiation: Radiation
- type
- NO_INTERVENTION
- label
- Control group
- description
- Regular postoperative follow-up
Primary outcomes (1)
- measure
- 3-year local recurrence-free survival
- timeFrame
- From a definitive pathological diagnosis to a 3-year follow-up
- description
- The percentage of the patients survive without local recurrence after a time period, from pathological diagnosis
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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).
References
Publications (0)
Data not yet available