- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05880667
Adaptive Radiation for Abdominopelvic Metastases
Adaptive Radiation for Abdominopelvic Metastases (ARAM)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Tanu singh
- Phone Number: 12152141439
- Email: tanu.singh@fccc.edu
Study Contact Backup
- Name: Joshua Meyer, MD
- Phone Number: 215-728-2667
- Email: Joshua.Meyer@fccc.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19111
- Recruiting
- Fox Chase Cancer Center
-
Principal Investigator:
- Joshua E. Meyer
-
Contact:
- Joshua E. Meyer, MD
- Phone Number: 215-728-2667
- Email: joshua.meyer@fccc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- Age > 18 years.
- ECOG performance status 0 or 1
- Estimated survival of >/= 12 months
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
- 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:
- 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.
- Subjects must not be receiving any other investigational agents.
- Subjects must not have known peritoneal carcinomatosis visible on imaging.
- Subjects must not have known active solid tumors on imaging outside of abdomen/pelvis noted on screening imaging
- Subjects must not have 6 or more active metastatic sites.
- Subjects must not have had prior radiotherapy to any target metastatic lesion. Prior radiotherapy to non-target sites is allowed.
- 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.
- Any condition or significant co-morbidity that prevents safe delivery of SBRT per the discretion of the treating physician(s).
- Subjects must not be pregnant or breast-feeding. Refer to section 4.4 for further detail.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adaptive Stereotactic Body Radiation
Simulation and treatment to be performed over 3-4 weeks per dose escalation
|
Radiation therapy is given following generation of planning imaging at the time of simulation. A recent development has been diagnostic quality onboard imaging incorporated within radiation treatment machines. The incorporation of onboard imaging into standard practice has allowed the use Stereotactic Body Radiation (SBRT), which is a precise radiation technique that allows safe delivery of ablative radiation doses. More recently, the development of improved technologies and software have allowed radiation plans to be generated and delivered that are specific to the anatomy of the very moment the patient is being treated. This novel ability to adjust the radiation treatment plan based upon real time imaging is termed adaptive radiation therapy. This study will utilize the novel adaptive radiation therapy technology in a patient population with technically challenging disease to deliver ablative radiation with an appropriately low toxicity rate. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the ability of adaptive SBRT to deliver increased doses of radiation safely to patients with challenging anatomical locations of metastatic disease without causing unacceptable toxicity.
Time Frame: 3 months
|
Cohorts of size 10 will be enrolled, Severe (grade 3) toxicity occurring within 3 months of treatment that is possibly, probably, or definitely related to trial therapy will be assessed.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joshua Meyer, MD, Fox Chase Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RT-218
- 23-1012 (Other Identifier: Fox Chase Cancer Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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