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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-120
SponsorNational Cancer Institute (NCI)

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Surgical resection
  • Preoperative RT

Treatment groups

32 Participants
are divided into 1 treatment group