Spots Global Cancer Trial Database for Adaptive Radiation for Abdominopelvic Metastases

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Adaptive Radiation for Abdominopelvic Metastases

Official Title: Adaptive Radiation for Abdominopelvic Metastases (ARAM)

Study ID: NCT05880667

Conditions

Neoplasm - Soft Tissue Pelvis Malignant Secondary

Malignant Neoplasm of Stomach

Interventions

Adaptive Stereotactic Body Radiation

Study Description

Brief 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.