Adaptive radiation treatment for metastatic cancer in the abdomen and pelvis
Adaptive Radiation for Abdominopelvic Metastases (ARAM)
This study is testing a new type of radiation therapy for patients with metastatic cancer in the abdomen or pelvis to see how much radiation can be safely given while helping to control symptoms and reduce side effects.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fox Chase Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05880667 on ClinicalTrials.gov |
What this trial studies
This Phase I trial investigates the use of adaptive stereotactic body radiation therapy (SBRT) for patients with metastatic cancer affecting the abdomen or pelvis. The study aims to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) by escalating doses of radiation while monitoring for dose-limiting toxicities. Participants will receive one of three dose levels, starting with 9Gy per fraction, and the study will utilize a Bayesian Optimal Interval Design to guide dose adjustments based on patient responses. The goal is to improve local control or palliation of metastatic lesions while minimizing severe side effects.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with confirmed metastatic cancer in the abdomen or pelvis, having at least one measurable target lesion.
Not a fit: Patients with non-metastatic cancer or those who have already received radiation treatment for their lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide improved local control of metastatic tumors with manageable side effects for patients.
How similar studies have performed: Other studies using adaptive SBRT have shown promise, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects must have histologically or cytologically confirmed cancer that is metastatic (all solid tumor types accepted), with at least one target lesion untreated by radiation, IR techniques, or growing in the abdomen or pelvis. Adjacent lymph nodes in the same region (5 cm or closer) constitute one active lesion. Target lesion must be measurable according to RECIST v 1.1. Previous systemic therapies are allowed. 2. Age \> 18 years. 3. ECOG performance status 0 or 1 4. Estimated survival of \>/= 12 months 5. Subjects must have normal organ and marrow function as defined below * Absolute neutrophil count \> 1,500/mcL * Platelets \> 100,000/mcL * Total bilirubin \< 2 mg/dL * AST/ALT (SGOT/SGPT) \< 5X ULN * Creatinine \< 1.5X ULN OR * Creatinine clearance ≥ 50 ml/min/1.73 m2 for subjects with creatinine levels above institutional normal 6. Subjects must possess the ability to understand and willingness to sign a written informed consent and HIPAA consent document. Translation services including translation of informed consent documents will be provided, as feasible, to encourage diversity of inclusion of eligible patients. Exclusion Criteria: 1. Subjects must not be experiencing toxicity due to prior therapy that has not resolved to ≤Grade 1 by study registration, with the exception of sensory neuropathy related to previous systemic therapy exposure, alopecia and fatigue. 2. Subjects must not be receiving any other investigational agents. 3. Subjects must not have known peritoneal carcinomatosis visible on imaging. 4. Subjects must not have known active solid tumors on imaging outside of abdomen/pelvis noted on screening imaging 5. Subjects must not have 6 or more active metastatic sites. 6. Subjects must not have had prior radiotherapy to any target metastatic lesion. Prior radiotherapy to non-target sites is allowed. 7. Subjects must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 8. Any condition or significant co-morbidity that prevents safe delivery of SBRT per the discretion of the treating physician(s). 9. Subjects must not be pregnant or breast-feeding. Refer to section 4.4 for further detail.
Where this trial is running
Philadelphia, Pennsylvania
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Joshua Meyer, MD — Fox Chase Cancer Center
- Study coordinator: Tanu Singh
- Email: tanu.singh@fccc.edu
- Phone: 12152141439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.