Actively Recruiting
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-14
32
Participants Needed
1
Research Sites
758 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathological confirmation of adrenocortical carcinoma (ACC)
- Measurable disease by RECIST v1.1 at enrollment
- Recurrent ACC that can be surgically removed at NIH Clinical Center
- Suitable for external beam radiotherapy and surgery as determined by the investigator
- Metastatic ACC outside the treatment area must be treatable by surgery or ablation
- Current, past, or no mitotane therapy; evaluated in separate cohorts
- Agree to tumor biopsy of accessible tumor sites before treatment
- ECOG performance status 0-2
- Adequate organ function including hemoglobin ≥ 9.0 gm/dL, ANC ≥ 1,500/mm³, platelets ≥ 75,000/mm³, AST and ALT ≤ 3 x ULN, bilirubin ≤ 2 x ULN, creatinine within normal limits or clearance > 60 mL/min/1.73 m²
- Use effective contraception before RT and until 4 months after surgery if of childbearing potential
- Agree to stop nursing before RT and until 4 months after surgery if breastfeeding
- Able to understand and sign informed consent
- Agree to co-enroll in tissue collection protocol 09C0242
You will not qualify if you...
- Primary ACC or adrenal tumor without pathological confirmation
- Prior abdominal radiation therapy
- Chemotherapy, immunotherapy, investigational therapy, or radiotherapy within 4 weeks before treatment or unresolved toxicities above grade 2
- Infection requiring intravenous antibiotics
- Known or suspected ACC peritoneal metastasis
- Known or suspected radiation sensitivity disorders
- Conditions preventing diagnostic laparoscopy
- High risk for major surgery or severe cardio-pulmonary complications
- Receiving other investigational therapies
- Pregnancy
- Active systemic infections, coagulation disorders, or major uncontrolled medical illnesses
- Acute intraabdominal conditions like obstruction or peritonitis
- Active or recent CNS metastasis within 6 months prior to RT
- HIV-positive with CD4 below 200 or not on antiretroviral therapy
- History of other primary cancer unless disease-free for at least 3 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
K
Kristine J Villaruel
CONTACT
N
Naris Nilubol, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here