Adrenocortical carcinoma · NCT06487481
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
- Status
- RECRUITING (ClinicalTrials.gov)
- Phase
- PHASE1
- Sponsor
- National Cancer Institute (NCI)
- Registry records
- CTGOV NCT06487481 (RECRUITING)Registry last updated 2026-11-06
Eligibility, line by line
| Verdict | In plain words (machine summary) | Registry text, verbatim | If unmet |
|---|---|---|---|
| inclusion inclusion · age sex · confidence 0.98 | Age >= 18 years | "Age \>= 18 years" | |
| inclusion inclusion · condition · confidence 0.95 | 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. | "Pathological confirmation of ACC by the Laboratory of Pathology, NCI." | |
| inclusion inclusion · lesion burden · confidence 0.97 | Measurable disease by RECISTv1.1. criteria at enrollment | "Measurable disease by RECISTv1.1. criteria at enrollment" | |
| inclusion inclusion · stage extent · confidence 0.85 | Evidence of recurrent ACC amenable to surgical resection that can be performed at NIH Clinical Center (CC) | "Evidence of recurrent ACC amenable to surgical resection that can be performed at NIH Clinical Center (CC)" | |
| inclusion inclusion · other · confidence 0.30 | Must be suitable for external beam radiotherapy AND surgery in the opinion of the treating investigator (e.g., based on clinical history and imaging) | "Must be suitable for external beam radiotherapy AND surgery in the opinion of the treating investigator" | |
| inclusion inclusion · stage extent · confidence 0.30 | 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. | "Participants with metastatic ACC outside the area(s) to be exposed to investigational treatments" | |
| inclusion inclusion · prior therapy · confidence 0.30 | Mitotane therapy- Participants may be receiving mitotane currently, have received it in the past, or never have received mitotane. Participants will be evaluated in separate cohorts based on mitotane use. | "Mitotane therapy- Participants may be receiving mitotane currently, have received it in the past, or never have received mitotane." | |
| inclusion inclusion · consent · confidence 0.30 | Participants must agree to undergo tumor biopsy of easily accessible tumor sites prior to study treatment. | "Participants must agree to undergo tumor biopsy of easily accessible tumor sites prior to study treatment." | |
| inclusion inclusion · performance status · confidence 0.98 | Performance Status (ECOG) 0-2 | "Performance Status (ECOG) 0-2" | |
| inclusion inclusion · lab value · confidence 0.98 | Hemoglobin >= 9.0 gm/dL | "Hemoglobin \>= 9.0 gm/dL" | |
| inclusion inclusion · lab value · confidence 0.98 | ANC >= 1,500/mm^3 | "ANC \>= 1,500/mm\^3" | |
| inclusion inclusion · lab value · confidence 0.98 | Platelets >= 75,000/mm^3 | "Platelets \>= 75,000/mm\^3" | |
| inclusion inclusion · lab value · confidence 0.97 | AST and ALT <= 3 x Upper Limit Normal (ULN) | "AST and ALT \<= 3 x Upper Limit Normal (ULN)" | |
| inclusion inclusion · lab value · confidence 0.98 | Bilirubin <= 2 x ULN | "Bilirubin \<= 2 x ULN" | |
| inclusion inclusion · organ function · confidence 0.90 | 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. | "Creatinine within normal institutional limits or creatinine clearance \>60 mL/min/1.73 m\^2" | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | Individuals of childbearing potential must agree to use an effective method of contraception prior to RT and continue until at least 4 months following cytoreduction surgery. | "Individuals of childbearing potential must agree to use an effective method of contraception" | |
| inclusion inclusion · pregnancy contraception · confidence 0.30 | Nursing (including breastfeeding) participants must agree to discontinue nursing prior to RT and continue until at least 4 months following cytoreductive surgery. | "Nursing (including breastfeeding) participants must agree to discontinue nursing prior to RT" | |
| inclusion inclusion · consent · confidence 0.30 | Ability of participant to understand and willingness to sign a written informed consent document | "Ability of participant to understand and willingness to sign a written informed consent document" | |
| inclusion inclusion · consent · confidence 0.30 | Participants must agree to co-enroll in tissue collection protocol 09C0242 "Prospective comprehensive molecular analysis of endocrine neoplasms." | "Participants must agree to co-enroll in tissue collection protocol 09C0242" | |
| exclusion exclusion · condition · confidence 0.90 | Primary ACC or suspicious/indeterminate adrenal tumor without pathological confirmation | "Primary ACC or suspicious/indeterminate adrenal tumor without pathological confirmation" | |
| exclusion exclusion · prior therapy · confidence 0.97 | Prior abdominal radiation therapy | "Prior abdominal radiation therapy" | |
| exclusion exclusion · washout · confidence 0.93 | 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. | "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." | |
| exclusion exclusion · comorbidity · confidence 0.95 | Infection requiring parenteral antibiotics | "Infection requiring parenteral antibiotics" | |
| exclusion exclusion · stage extent · confidence 0.95 | Suspected or proven ACC peritoneal metastasis | "Suspected or proven ACC peritoneal metastasis" | |
| exclusion exclusion · comorbidity · confidence 0.95 | Pre-existing known or suspected radiation sensitivity syndromes | "Pre-existing known or suspected radiation sensitivity syndromes" | |
| exclusion exclusion · comorbidity · confidence 0.30 | Prohibitive condition(s) to diagnostic laparoscopy | "Prohibitive condition(s) to diagnostic laparoscopy" | |
| exclusion exclusion · comorbidity · confidence 0.30 | Participants who have an unacceptable risk for a major surgical procedure such as high risks for major cerebro-cardiovascular and pulmonary complications and those with estimated perioperative mortality greater than 15% per ACS NSQIP Surgical Risk calculator. | "Participants who have an unacceptable risk for a major surgical procedure" | |
| exclusion exclusion · prior therapy · confidence 0.93 | Participants receiving other investigational therapies | "Participants receiving other investigational therapies" | |
| exclusion exclusion · pregnancy contraception · confidence 0.97 | Participant pregnancy | "Participant pregnancy" | |
| exclusion exclusion · comorbidity · confidence 0.92 | 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. | "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." | |
| exclusion exclusion · comorbidity · confidence 0.95 | Acute intraabdominal conditions such as obstruction or peritonitis at the time of the evaluation or surgery. | "Acute intraabdominal conditions such as obstruction or peritonitis at the time of the evaluation or surgery." | |
| exclusion exclusion · comorbidity · confidence 0.93 | 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. | "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." | |
| exclusion exclusion · comorbidity · confidence 0.93 | HIV-positive participants with CD4 below 200 or who are not on anti-retroviral therapy | "HIV-positive participants with CD4 below 200 or who are not on anti-retroviral therapy" | |
| exclusion exclusion · comorbidity · confidence 0.95 | 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. | "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." |
Criteria extracted by claude-sonnet-5-5; 0 extracted quotes rejected for not matching the registry text.
Full eligibility text as the registry publishes it
* 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.
Routes in: how this trial is reached and paid for
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Care 0; transatlantic flight at your own cost, then supported
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- National Institutes of Health Clinical Center, Bethesda