Options mapped
Adrenocortical carcinoma: options by country
Sourced options by country plus visit-prep questions for Adrenocortical carcinoma. Each line links to its regulator, HTA, or guideline source. This page maps options; it does not recommend or rank them.
What this page does
Maps options by country
It maps sourced options by country alongside diagnosis wording, stage, test results, specialists, and trial-search terms.
What it does not do
Does not choose treatment
It does not rank treatments, recommend a choice, or decide clinical fit.
Where it comes from
Built on trusted sources
Every option links to a trusted regulator, HTA, or guideline source, and the list grows as new sources pass verification.
Information to gather before the next visit
- Is complete surgical resection feasible at an ACC-experienced center?
- Is mitotane being discussed as adjuvant, unresectable, metastatic, or symptom-control therapy?
- Are hormone-producing symptoms being managed alongside cancer-directed treatment?
- Is the ACC inoperable, functional, or nonfunctional under the U.S. label indication?
Trial-search terms to discuss
Options by country
Treatments by country
Regulatory and access status by country, from official sources. It shows what exists and where — not a recommendation.
United States
- Mitotane (Lysodren)[1]FDA-approvedFunctional versus nonfunctional hormonal status is clinically relevant; no genomic biomarker required by fetched U.S. label; Inoperable functional or nonfunctional ACC. · Label indication does not establish payer coverage, treatment suitability, or dosing for a specific patient. Label includes major safety updates and monitoring/handling precautions. Confidence/conflicts: High for U.S. labeled indication.
- Mitotane (Lysodren)[1]FDA-approvedFunctional versus nonfunctional hormonal status is clinically relevant; no genomic biomarker required by fetched U.S. label; Inoperable functional or nonfunctional ACC. · Label indication does not establish payer coverage, treatment suitability, or dosing for a specific patient. Label includes major safety updates and monitoring/handling precautions. Confidence/conflicts: High for U.S. labeled indication.
European Union
- Mitotane (Lysodren)[2]EMA authorisedFunctional hormone-producing status affects symptom benefit; no genomic biomarker required by fetched EMA source; Advanced unresectable, metastatic, or relapsed ACC; symptom treatment context per EMA wording. · EMA central authorisation does not establish member-state reimbursement, local specialist access, or individual eligibility. EMA notes limited evidence for some uses and the need for blood-level monitoring. Confidence/conflicts: High for EU authorised indication; national reimbursement remains unverified.
- Mitotane (Lysodren)[2]EMA authorisedFunctional hormone-producing status affects symptom benefit; no genomic biomarker required by fetched EMA source; Advanced unresectable, metastatic, or relapsed ACC; symptom treatment context per EMA wording. · EMA central authorisation does not establish member-state reimbursement, local specialist access, or individual eligibility. EMA notes limited evidence for some uses and the need for blood-level monitoring. Confidence/conflicts: High for EU authorised indication; national reimbursement remains unverified.
- Mitotane (Lysodren)[2]EMA authorisedFunctional hormone-producing status affects symptom benefit; no genomic biomarker required by fetched EMA source; Advanced unresectable, metastatic, or relapsed ACC; symptom treatment context per EMA wording. · EMA central authorisation does not establish member-state reimbursement, local specialist access, or individual eligibility. EMA notes limited evidence for some uses and the need for blood-level monitoring. Confidence/conflicts: High for EU authorised indication; national reimbursement remains unverified.
United Kingdom
- Mitotane (Lysodren), alone or with other chemotherapy drugs[3]ApprovedNo biomarker required by fetched UK source; Unresectable, relapsed, or metastatic ACC. · Cancer Research UK is a patient/professional cancer information charity, not MHRA/NICE. Exact UK licensing, commissioning, and local formulary status require separate regulator/NHS source verification. Confidence/conflicts: Medium-high for UK treatment-information context; exact MHRA/NICE status remains an active gap.
- Mitotane (Lysodren), alone or with other chemotherapy drugs[3]ApprovedNo biomarker required by fetched UK source; Unresectable, relapsed, or metastatic ACC. · Cancer Research UK is a patient/professional cancer information charity, not MHRA/NICE. Exact UK licensing, commissioning, and local formulary status require separate regulator/NHS source verification. Confidence/conflicts: Medium-high for UK treatment-information context; exact MHRA/NICE status remains an active gap.
Sources
- DailyMed / U.S. FDA label — official drug label · official drug label
- European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
- Cancer Research UK — UK cancer information / drug information · UK cancer information / drug information
This is official regulatory and access status only — not medical advice, not a recommendation, and not a statement about eligibility. Whether any option fits depends on your situation and your oncology team. Status changes over time; confirm the current position with the linked source. Last checked 2026-06-12.
Beyond approved care
In clinical trials & emerging options
Options that are not — or not yet — an approved standard where you live: studies, clinical trials, off-label use, and early evidence that your own oncologist may not raise. Each is labeled by how strong the evidence is. A listing here is information to research and discuss with your team; it does not mean a treatment is proven, safe for you, or available today.
In clinical trials
- Complete surgical removal; adjuvant mitotane under clinical evaluation; radiation therapy for selected unresectable/localized or metastatic sites; mitotane; mitotane plus streptozotocin or mitotane plus etoposide/doxorubicin/cisplatin; antisteroidogenic drugs for hormone excess; clinical trialsClinical trialClinical trialInvestigationalUnited States · No biomarker required by fetched NCI PDQ source; Stage I-II localized ACC, stage III locally advanced ACC, stage IV metastatic ACC, recurrent ACC, hormone-producing ACC symptom control. · NCI PDQ is an evidence summary and not a formal guideline, payer, or regulator source. Adjuvant mitotane and several radiation/systemic approaches are described as under clinical evaluation. Confidence/conflicts: High for U.S. evidence-summary framework; regulator-specific mitotane indication recorded separately. National Cancer Institute (NCI) — national cancer agency evidence summary
- Complete surgical removal; adjuvant mitotane under clinical evaluation; radiation therapy for selected unresectable/localized or metastatic sites; mitotane; mitotane plus streptozotocin or mitotane plus etoposide/doxorubicin/cisplatin; antisteroidogenic drugs for hormone excess; clinical trialsClinical trialClinical trialInvestigationalUnited States · No biomarker required by fetched NCI PDQ source; Stage I-II localized ACC, stage III locally advanced ACC, stage IV metastatic ACC, recurrent ACC, hormone-producing ACC symptom control. · NCI PDQ is an evidence summary and not a formal guideline, payer, or regulator source. Adjuvant mitotane and several radiation/systemic approaches are described as under clinical evaluation. Confidence/conflicts: High for U.S. evidence-summary framework; regulator-specific mitotane indication recorded separately. National Cancer Institute (NCI) — national cancer agency evidence summary
- Complete surgical removal; adjuvant mitotane under clinical evaluation; radiation therapy for selected unresectable/localized or metastatic sites; mitotane; mitotane plus streptozotocin or mitotane plus etoposide/doxorubicin/cisplatin; antisteroidogenic drugs for hormone excess; clinical trialsClinical trialClinical trialInvestigationalUnited States · No biomarker required by fetched NCI PDQ source; Stage I-II localized ACC, stage III locally advanced ACC, stage IV metastatic ACC, recurrent ACC, hormone-producing ACC symptom control. · NCI PDQ is an evidence summary and not a formal guideline, payer, or regulator source. Adjuvant mitotane and several radiation/systemic approaches are described as under clinical evaluation. Confidence/conflicts: High for U.S. evidence-summary framework; regulator-specific mitotane indication recorded separately. National Cancer Institute (NCI) — national cancer agency evidence summary
- Complete surgical removal; adjuvant mitotane under clinical evaluation; radiation therapy for selected unresectable/localized or metastatic sites; mitotane; mitotane plus streptozotocin or mitotane plus etoposide/doxorubicin/cisplatin; antisteroidogenic drugs for hormone excess; clinical trialsClinical trialClinical trialInvestigationalUnited States · No biomarker required by fetched NCI PDQ source; Stage I-II localized ACC, stage III locally advanced ACC, stage IV metastatic ACC, recurrent ACC, hormone-producing ACC symptom control. · NCI PDQ is an evidence summary and not a formal guideline, payer, or regulator source. Adjuvant mitotane and several radiation/systemic approaches are described as under clinical evaluation. Confidence/conflicts: High for U.S. evidence-summary framework; regulator-specific mitotane indication recorded separately. National Cancer Institute (NCI) — national cancer agency evidence summary
- Complete surgical removal; adjuvant mitotane under clinical evaluation; radiation therapy for selected unresectable/localized or metastatic sites; mitotane; mitotane plus streptozotocin or mitotane plus etoposide/doxorubicin/cisplatin; antisteroidogenic drugs for hormone excess; clinical trialsClinical trialClinical trialInvestigationalUnited States · No biomarker required by fetched NCI PDQ source; Stage I-II localized ACC, stage III locally advanced ACC, stage IV metastatic ACC, recurrent ACC, hormone-producing ACC symptom control. · NCI PDQ is an evidence summary and not a formal guideline, payer, or regulator source. Adjuvant mitotane and several radiation/systemic approaches are described as under clinical evaluation. Confidence/conflicts: High for U.S. evidence-summary framework; regulator-specific mitotane indication recorded separately. National Cancer Institute (NCI) — national cancer agency evidence summary
- Complete surgical removal; adjuvant mitotane under clinical evaluation; radiation therapy for selected unresectable/localized or metastatic sites; mitotane; mitotane plus streptozotocin or mitotane plus etoposide/doxorubicin/cisplatin; antisteroidogenic drugs for hormone excess; clinical trialsClinical trialClinical trialInvestigationalUnited States · No biomarker required by fetched NCI PDQ source; Stage I-II localized ACC, stage III locally advanced ACC, stage IV metastatic ACC, recurrent ACC, hormone-producing ACC symptom control. · NCI PDQ is an evidence summary and not a formal guideline, payer, or regulator source. Adjuvant mitotane and several radiation/systemic approaches are described as under clinical evaluation. Confidence/conflicts: High for U.S. evidence-summary framework; regulator-specific mitotane indication recorded separately. National Cancer Institute (NCI) — national cancer agency evidence summary
- OsilodrostatClinical trial · NCT02468193Clinical trialTrial only (registry)Japan · Hormone-producing Cushing syndrome context; no genomic biomarker required by fetched registry record; Cushing syndrome and related adrenal disease context including adrenal carcinoma. · This is not an ACC-directed anticancer trial; it is a hormonal/symptom-control context that includes adrenal carcinoma. Registry listing does not establish PMDA approval, reimbursement, routine access, or individual eligibility. Confidence/conflicts: Medium for Japan ACC-related supportive/hormonal trial context; low for Japan tumor-directed ACC treatment availability. ClinicalTrials.gov — clinical-trial registry
- OsilodrostatClinical trial · NCT02468193Clinical trialTrial only (registry)Japan · Hormone-producing Cushing syndrome context; no genomic biomarker required by fetched registry record; Cushing syndrome and related adrenal disease context including adrenal carcinoma. · This is not an ACC-directed anticancer trial; it is a hormonal/symptom-control context that includes adrenal carcinoma. Registry listing does not establish PMDA approval, reimbursement, routine access, or individual eligibility. Confidence/conflicts: Medium for Japan ACC-related supportive/hormonal trial context; low for Japan tumor-directed ACC treatment availability. ClinicalTrials.gov — clinical-trial registry
- Pembrolizumab plus lenvatinib; real-world adrenal disease registry/cohort management studiesClinical trial · NCT05036434Clinical trialTrial only (registry)Korea · No biomarker required by fetched Korea registry records; Advanced adrenal cortical carcinoma for pembrolizumab/lenvatinib; adrenal disease evidence-generation/cohort contexts including ACC. · Registry records do not establish MFDS approval, reimbursement, routine access, or individual eligibility. Observational adrenal disease records are not treatment access records. Confidence/conflicts: Medium-high for Korea registry-listed ACC trial/cohort activity; routine access unverified. ClinicalTrials.gov — clinical-trial registry
- Pembrolizumab plus lenvatinib; real-world adrenal disease registry/cohort management studiesClinical trial · NCT05036434Clinical trialTrial only (registry)Korea · No biomarker required by fetched Korea registry records; Advanced adrenal cortical carcinoma for pembrolizumab/lenvatinib; adrenal disease evidence-generation/cohort contexts including ACC. · Registry records do not establish MFDS approval, reimbursement, routine access, or individual eligibility. Observational adrenal disease records are not treatment access records. Confidence/conflicts: Medium-high for Korea registry-listed ACC trial/cohort activity; routine access unverified. ClinicalTrials.gov — clinical-trial registry
- Pembrolizumab plus lenvatinib; real-world adrenal disease registry/cohort management studiesClinical trial · NCT05036434Clinical trialTrial only (registry)Korea · No biomarker required by fetched Korea registry records; Advanced adrenal cortical carcinoma for pembrolizumab/lenvatinib; adrenal disease evidence-generation/cohort contexts including ACC. · Registry records do not establish MFDS approval, reimbursement, routine access, or individual eligibility. Observational adrenal disease records are not treatment access records. Confidence/conflicts: Medium-high for Korea registry-listed ACC trial/cohort activity; routine access unverified. ClinicalTrials.gov — clinical-trial registry
- Pembrolizumab plus lenvatinib; real-world adrenal disease registry/cohort management studiesClinical trial · NCT05036434Clinical trialTrial only (registry)Korea · No biomarker required by fetched Korea registry records; Advanced adrenal cortical carcinoma for pembrolizumab/lenvatinib; adrenal disease evidence-generation/cohort contexts including ACC. · Registry records do not establish MFDS approval, reimbursement, routine access, or individual eligibility. Observational adrenal disease records are not treatment access records. Confidence/conflicts: Medium-high for Korea registry-listed ACC trial/cohort activity; routine access unverified. ClinicalTrials.gov — clinical-trial registry
- Camrelizumab plus apatinib plus mitotane; adjuvant radiotherapy versus observation; camrelizumab plus apatinib second-line; individualized mRNA neoantigen vaccine (mRNA-0523-L001); triprolizumab plus radiotherapy; China adrenal disease registryClinical trial · NCT06831175Clinical trialTrial only (registry)China · Individualized mRNA neoantigen vaccine study implies tumor-specific neoantigen selection; no other biomarker required by fetched China registry records; Advanced ACC; high-risk localized ACC after surgery; recurrent/metastatic ACC; advanced endocrine tumor including ACC. · Registry records do not establish NMPA approval, reimbursement, routine access, active enrollment for all studies, or individual eligibility. Some records are registry or not-yet-recruiting rather than treatment access. Confidence/conflicts: High for China registry-listed ACC trial activity; local approval/access status unverified. ClinicalTrials.gov — clinical-trial registry
- Camrelizumab plus apatinib plus mitotane; adjuvant radiotherapy versus observation; camrelizumab plus apatinib second-line; individualized mRNA neoantigen vaccine (mRNA-0523-L001); triprolizumab plus radiotherapy; China adrenal disease registryClinical trial · NCT06831175Clinical trialTrial only (registry)China · Individualized mRNA neoantigen vaccine study implies tumor-specific neoantigen selection; no other biomarker required by fetched China registry records; Advanced ACC; high-risk localized ACC after surgery; recurrent/metastatic ACC; advanced endocrine tumor including ACC. · Registry records do not establish NMPA approval, reimbursement, routine access, active enrollment for all studies, or individual eligibility. Some records are registry or not-yet-recruiting rather than treatment access. Confidence/conflicts: High for China registry-listed ACC trial activity; local approval/access status unverified. ClinicalTrials.gov — clinical-trial registry
- Camrelizumab plus apatinib plus mitotane; adjuvant radiotherapy versus observation; camrelizumab plus apatinib second-line; individualized mRNA neoantigen vaccine (mRNA-0523-L001); triprolizumab plus radiotherapy; China adrenal disease registryClinical trial · NCT06831175Clinical trialTrial only (registry)China · Individualized mRNA neoantigen vaccine study implies tumor-specific neoantigen selection; no other biomarker required by fetched China registry records; Advanced ACC; high-risk localized ACC after surgery; recurrent/metastatic ACC; advanced endocrine tumor including ACC. · Registry records do not establish NMPA approval, reimbursement, routine access, active enrollment for all studies, or individual eligibility. Some records are registry or not-yet-recruiting rather than treatment access. Confidence/conflicts: High for China registry-listed ACC trial activity; local approval/access status unverified. ClinicalTrials.gov — clinical-trial registry
- Camrelizumab plus apatinib plus mitotane; adjuvant radiotherapy versus observation; camrelizumab plus apatinib second-line; individualized mRNA neoantigen vaccine (mRNA-0523-L001); triprolizumab plus radiotherapy; China adrenal disease registryClinical trial · NCT06831175Clinical trialTrial only (registry)China · Individualized mRNA neoantigen vaccine study implies tumor-specific neoantigen selection; no other biomarker required by fetched China registry records; Advanced ACC; high-risk localized ACC after surgery; recurrent/metastatic ACC; advanced endocrine tumor including ACC. · Registry records do not establish NMPA approval, reimbursement, routine access, active enrollment for all studies, or individual eligibility. Some records are registry or not-yet-recruiting rather than treatment access. Confidence/conflicts: High for China registry-listed ACC trial activity; local approval/access status unverified. ClinicalTrials.gov — clinical-trial registry
- Camrelizumab plus apatinib plus mitotane; adjuvant radiotherapy versus observation; camrelizumab plus apatinib second-line; individualized mRNA neoantigen vaccine (mRNA-0523-L001); triprolizumab plus radiotherapy; China adrenal disease registryClinical trial · NCT06831175Clinical trialTrial only (registry)China · Individualized mRNA neoantigen vaccine study implies tumor-specific neoantigen selection; no other biomarker required by fetched China registry records; Advanced ACC; high-risk localized ACC after surgery; recurrent/metastatic ACC; advanced endocrine tumor including ACC. · Registry records do not establish NMPA approval, reimbursement, routine access, active enrollment for all studies, or individual eligibility. Some records are registry or not-yet-recruiting rather than treatment access. Confidence/conflicts: High for China registry-listed ACC trial activity; local approval/access status unverified. ClinicalTrials.gov — clinical-trial registry
A clinical-trial listing or early report shows an option is being studied — not that it works, that it is safe for any one person, or that a site is enrolling today. Whether any of these fits is a conversation for your oncology team and the trial team. Last checked 2026-06-12.