Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma

Recruiting now · Phase 1

Conditions studied: Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC), Recurrent Abdominal Adrenocortical Carcinoma (ACC), Carcinoma, Adrenocortical, Carcinoma, Adrenal Cortical

In brief

Background: Adrenocortical carcinoma (ACC) is a rare cancer of the adrenal glands. ACC often returns after tumors are removed with surgery. Less than 35% of people with ACC survive 5 years after diagnosis. Objective: To test a new type of external beam RT before surgery in people with ACC. Eligibility: People aged 18 years and older with ACC that came back after treatment but may be safely removed with surgery. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have tests of their heart function. They will have imaging scans. A small sample of tumor tissue may be collected if one is not available. They will undergo laparoscopy: Small incisions will be made in the abdomen so that a thin tube with a light and camera can be inserted to view the organs. RT comes from a machine that aims radiation at tumors. Participants will receive preoperative RT in daily fractions over approximately 2-3 weeks, followed by a planned surgical resection about 4 weeks after the completion of RT. Visits will last 30 to 60 minutes. Participants will undergo surgery to remove their tumors about 4 weeks after they finish RT. They will stay in the hospital 1 to 3 weeks after surgery. Participants will have follow-up visits for 10 years after surgery.

Key facts

Study ID

NCT06487481

Run by

National Cancer Institute (NCI)

People needed

32

Starts

2026-08-13

Expected to finish

2040-12-01

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.