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New treatment option for Adrenocortical Carcinoma (ACC)
Official title Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
ClinicalTrials.gov ID: NCT06487481
What this study is testing
- What it's testing
- Background: Adrenocortical carcinoma (ACC) is a rare cancer of the adrenal glands. ACC often returns after tumors are removed with surgery.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- 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...
- 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)
You likely can't join 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...
- Infection requiring parenteral antibiotics
- Suspected or proven ACC peritoneal metastasis
- Pre-existing known or suspected radiation sensitivity syndromes
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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."
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.