New radiation approach before surgery for rare adrenal cancer
NCT ID NCT06487481
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 58 times
Summary
This early-phase trial tests giving radiation therapy before surgery to people whose adrenal cancer has come back. The goal is to find a safe radiation dose and see if it helps shrink tumors before removal. About 32 adults with resectable recurrent ACC will receive daily radiation for 2-3 weeks, then have surgery 4 weeks later, and be followed for up to 10 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy
- What this could lead to
- If it works, this could make surgery more effective for recurrent ACC and improve how long people live without the cancer coming back.
- What could go wrong
- This is a very early phase 1 trial with only 32 people, so it is not yet clear if the radiation helps. There are risks from radiation and surgery, and the cancer may still return.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2040
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * 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 CRITERIA: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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