Study of Preoperative Radiation Therapy for Recurrent Adrenocortical Carcinoma
This study is looking at a new way to treat recurrent adrenocortical carcinoma (ACC), a rare cancer of the adrenal glands. It's testing if giving radiation therapy (RT) before surgery can be safe and help prevent the cancer from coming back. Participants will receive preoperative RT over 2-3 weeks, followed by surgical removal of the tumor about 4 weeks later. The main goal is to find the highest safe dose of this preoperative RT and understand any side effects. You may be able to join if you are 18 or older, have ACC that has returned but can be removed with surgery, and have a confirmed diagnosis of ACC. This study is currently unclear about its recruitment status and plans to enroll 32 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is a dose-escalation trial, meaning different groups will receive increasing doses of radiation.
- What's involved
- You will undergo screening, which includes a physical exam, blood and urine tests, heart function tests, and imaging scans. A tumor tissue sample may also be collected. You will then receive preoperative RT for 2-3 weeks, followed by surgery about 4 weeks later.
- Compensation
- Not stated in the trial record.
- Follow-up
- The safety and side effects of the treatment will be monitored from the start of radiation therapy and for 30 days after its completion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06487481
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~32 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:Surgical resectionPreoperative RT
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the maximum tolerated dose (MTD) and safety and toxicity profile of preoperative external beam radiation therapy (RT) with or without standard-of-care mitotane, before surgical resection in participants with resectable recurrent ACC
Measured over from the start of RT and for 30 days after its completion
Conditions
NCT06487481
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
National Institutes of Health Clinical Center
Bethesda, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Naris Nilubol, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age \>= 18 years
Pathological confirmation of ACC by the Laboratory of Pathology, NCI. Note: Confirmation may be done from archival sample; fresh tissue is not required unless otherwise acquired for clinical purposes.
Measurable disease by RECISTv1.1. criteria at enrollment
Evidence of recurrent ACC amenable to surgical resection that can be performed at NIH Clinical Center (CC)
Must be suitable for external beam radiotherapy AND surgery in the opinion of the treating investigator (e.g., based on clinical history and imaging)
Participants with metastatic ACC outside the area(s) to be exposed to investigational treatments (e.g., liver parenchyma, lung\[s\], or bone\[s\]) must have disease that is amendable for a complete resection and/or catheter-based and/or radiation-based ablation.
Mitotane therapy- Participants may be receiving mitotane currently, have received it in the past, or never have received mitotane. However, participants will be evaluated in separate cohorts based on mitotane use and, as enrollment is sequential, not all participants may be eligible for the study at all times. Note: Participants with a history of mitotane use may continue on study at the discretion of the treating investigator. Participants will not initiate mitotane on study.
Participants must agree to undergo tumor biopsy of easily accessible tumor sites prior to study treatment.
Performance Status (ECOG) 0-2
Adequate organ function, including:
Hemoglobin \>= 9.0 gm/dL
ANC \>= 1,500/mm\^3
Platelets \>= 75,000/mm\^3
AST and ALT \<= 3 x Upper Limit Normal (ULN)
Bilirubin \<= 2 x ULN
Creatinine within normal institutional limits or creatinine clearance \>60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal calculated using eGFR.
Individuals of childbearing potential must agree to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) prior to RT and continue until at least 4 months following cytoreduction surgery.
Nursing (including breastfeeding) participants must agree to discontinue nursing prior to RT and continue until at least 4 months following cytoreductive surgery.
Ability of participant to understand and willingness to sign a written informed consent document
Participants must agree to co-enroll in tissue collection protocol 09C0242 "Prospective comprehensive molecular analysis of endocrine neoplasms."
Exclusion
Primary ACC or suspicious/indeterminate adrenal tumor without pathological confirmation
Prior abdominal radiation therapy
Participants who have received chemotherapy, immunotherapy, investigational therapy, or radiotherapy treatment within the last 4 weeks prior to starting treatment and/or have not recovered from toxicities to less than grade 2 CTCAE.
Infection requiring parenteral antibiotics
Suspected or proven ACC peritoneal metastasis
Pre-existing known or suspected radiation sensitivity syndromes
Prohibitive condition(s) to diagnostic laparoscopy
Participants who have an unacceptable risk for a major surgical procedure such as participants with high risks for major cerebro-cardiovascular (such as those who had doxorubicin exposure as based on screening echocardiogram and ECG) and pulmonary complications and those with estimated perioperative mortality greater than 15% per ACS NSQIP Surgical Risk calculator.
Participants receiving other investigational therapies
Participant pregnancy
Active systemic infections, coagulation disorders, or other major medical illnesses such as uncontrolled diabetes mellitus, uncontrolled hypertension (persistently grade 2 or worse), active severe cerebro-cardio-pulmonary diseases, and acute major organ dysfunction.
Acute intraabdominal conditions such as obstruction or peritonitis at the time of the evaluation or surgery.
Evidence at screening of or currently active CNS metastasis within 6 months of RT; participants with history of treated brain metastases with intracranial recurrence within 6 months prior to treatment. Note: Participants with any signs or symptoms suggestive of previously undiagnosed brain metastasis at screening or with a history of brain metastasis should receive imaging at screening; otherwise, imaging is not required.
HIV-positive participants with CD4 below 200 or who are not on anti-retroviral therapy
Participants who have a history of another primary malignancy from which the participant has been disease-free for \< 3 years at the time of enrollment.
What this trial measures
- Determine the maximum tolerated dose (MTD) and safety and toxicity profile of preoperative external beam radiation therapy (RT) with or without standard-of-care mitotane, before surgical resection in participants with resectable recurrent ACCfrom the start of RT and for 30 days after its completion
Fraction of participants with a dose-limiting toxicity (DLT) will be reported at each dose level