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

Status: NOT_YET_RECRUITING (ClinicalTrials.gov)Not yet recruiting
Phase: NA
Sponsor: Sun Yat-sen University
Registry records: CTGOV NCT07141147 (NOT_YET_RECRUITING)
Registry last updated 2025-09-03

Eligibility, line by line

Criteria extracted by claude-sonnet-5-5; 0 extracted quotes rejected for not matching the registry text.

Full eligibility text as the registry publishes it

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).

Routes in: how this trial is reached and paid for

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Cancer Center, Sun Yat-sen University, Guangzhou

Verdict	In plain words (machine summary)	Registry text, verbatim
inclusion inclusion · age sex · confidence 0.98	age ≥ 18 years and ≤ 75 years.	"age ≥ 18 years and ≤ 75 years"
inclusion inclusion · performance status · confidence 0.98	ECOG performance status score ≤ 1	"ECOG performance status score ≤ 1"
inclusion inclusion · life expectancy · confidence 0.90	expected survival period ≥ 6 months	"expected survival period ≥ 6 months"
inclusion inclusion · prior therapy · confidence 0.95	Completion of radical resection for adrenocortical carcinoma (ACC) with curative intent.	"Completion of radical resection for adrenocortical carcinoma (ACC) with curative intent."
inclusion inclusion · condition · confidence 0.97	Postoperative pathological diagnosis of adrenocortical carcinoma.	"Postoperative pathological diagnosis of adrenocortical carcinoma."
inclusion inclusion · stage extent · confidence 0.90	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.	"Pathological stage is localized ACC: ENSAT stage 1-3"
inclusion inclusion · other · confidence 0.30	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.	"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."
inclusion inclusion · stage extent · confidence 0.70	Postoperative imaging review prior to radiotherapy shows no evidence of residual or metastatic disease.	"Postoperative imaging review prior to radiotherapy shows no evidence of residual or metastatic disease."
exclusion exclusion · stage extent · confidence 0.95	ENSAT Stage 4 adrenocortical carcinoma.	"ENSAT Stage 4 adrenocortical carcinoma."
exclusion exclusion · performance status · confidence 0.30	Karnofsky Performance Status (KPS) score ≤ 70	"Karnofsky Performance Status (KPS) score ≤ 70"
exclusion exclusion · performance status · confidence 0.95	Zubrod score > 2	"Zubrod score \> 2"
exclusion exclusion · prior therapy · confidence 0.95	Prior radiotherapy to the abdomen or pelvis.	"Prior radiotherapy to the abdomen or pelvis."
exclusion exclusion · organ function · confidence 0.30	Insufficient function of major organs (heart, lung, liver, kidney, bone marrow hematopoiesis) precluding tolerance to radiotherapy.	"Insufficient function of major organs (heart, lung, liver, kidney, bone marrow hematopoiesis) precluding tolerance to radiotherapy."
exclusion exclusion · pregnancy contraception · confidence 0.30	Pregnant or lactating women, and subjects of childbearing potential unwilling to use contraception.	"Pregnant or lactating women, and subjects of childbearing potential unwilling to use contraception."
exclusion exclusion · comorbidity · confidence 0.90	Patients with psychiatric disorders, history of alcoholism or substance abuse	"Patients with psychiatric disorders, history of alcoholism or substance abuse"
exclusion exclusion · consent · confidence 0.30	those unable to provide informed consent	"those unable to provide informed consent"
exclusion exclusion · other · confidence 0.30	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.	"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."
exclusion exclusion · comorbidity · confidence 0.90	Patients with other concurrent primary cancers	"Patients with other concurrent primary cancers"
exclusion exclusion · comorbidity · confidence 0.92	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).	"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)"

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

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