NCT05880667

Adaptive Radiation for Abdominopelvic Metastases

Adaptive Radiation for Abdominopelvic Metastases (ARAM)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single arm Phase I trial of adaptive stereotactic body radiation (SBRT) for abdominopelvic metastases. Adaptive SBRT will allow for escalation of the prescription dose and target coverage while maintaining grade 3+ toxicity no greater than 10%. Subjects with metastatic cancer to the abdomen or pelvis requiring local control or palliation will be enrolled.

Detailed description

This is a dose-escalation study where the objective is to find the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of adaptive SBRT for abdominopelvic SBRT. There are 3 doses of interest 8Gy/fraction (level 1), 9Gy/fraction (level 2), and 10Gy/fraction (level 3). The starting dose will be level 2. We will use a Bayesian Optimal Interval Design (BOIN) to define dose escalation and de-escalation rules based on the proportion of patients experiencing a dose-limiting toxicity (DLT). DLT events are Grade 3 events possibly, probably, or definitely related to the study intervention.

Conditions

• Neoplasm - Soft Tissue Pelvis Malignant Secondary
• Malignant Neoplasm of Stomach

Interventions

Type	Name	Description
RADIATION	Adaptive Stereotactic Body Radiation	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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2028-06-01
• Completion: 2029-06-01
• First posted: 2023-05-30
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States