Adaptive Radiation for Abdominopelvic Metastases

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05880667
Study type	Interventional
Source	Fox Chase Cancer Center
Contact	Tanu Singh
Phone	12152141439
Email	tanu.singh@fccc.edu
Status	Recruiting
Phase	Phase 1
Start date	August 1, 2023
Completion date	June 1, 2029

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT01727908` - Screening for Familial Gastric Cancer in First Degree Relatives	N/A
Completed	`NCT02337673` - Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography
Completed	`NCT02158988` - Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis	Phase 3
Recruiting	`NCT01642953` - Early Recovery After Gastric Cancer Surgery	Phase 2
Active, not recruiting	`NCT02205047` - Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction Adenocarcinoma	Phase 2
Recruiting	`NCT02381847` - Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients	Phase 3
Completed	`NCT01443065` - MEGA (Met or EGFR Inhibition in Gastroesophageal Adenocarcinoma): FOLFOX Alone or in Combination With AMG 102 or Panitumumab as First-line Treatment in Patients With Advanced Gastroesophageal Adenocarcinoma	Phase 2
Completed	`NCT01758965` - Surgicel® Fibrillar for Delayed Bleeding After ESD	N/A
Completed	`NCT02528110` - Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer	Phase 2
Completed	`NCT01187212` - Sorafenib Trial in Advanced and/or Recurrent Gastric Adenocarcinoma: Treatment Evaluation: STARGATE	Phase 2
Recruiting	`NCT04345770` - Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer	Phase 2