RecruitingPhase 1NCT06487481

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

A Phase I Dose-escalation Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma


Sponsor

National Cancer Institute (NCI)

Enrollment

32 participants

Start Date

May 6, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether giving radiation therapy before surgery improves outcomes for people with adrenocortical carcinoma (cancer of the outer part of the adrenal gland) that has come back after initial treatment and can potentially be surgically removed again. **You may be eligible if...** - You are 18 or older - You have been diagnosed with adrenocortical carcinoma confirmed by pathology - Your cancer has come back and your doctors believe surgery is feasible at the NIH Clinical Center - You have at least one measurable area of disease - You are medically suitable to receive radiation and undergo surgery - You may or may not be currently taking mitotane (a common drug for this cancer) **You may NOT be eligible if...** - Your cancer has not come back or is not surgically operable - You are not eligible to undergo surgery at the NIH Clinical Center - You have conditions that make radiation or surgery unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURESurgical resection

Planned surgical resection (all participants) 4 weeks after completion of the preoperative RT

RADIATIONPreoperative RT

Preoperative RT at escalating doses in daily fractions over approximately 2-3 weeks; 2 weeks (DL1), or 3 weeks (DL2 or DL3) based on assigned Cohort and Dose Level (DL). Cohorts are by mitotane status at enrollment: Cohort 1 (with detectable mitotane levels), Cohort 2 (never had or without detectable mitotane levels), Cohort 3 (either).


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06487481


Related Trials