Adaptive Radiation for Abdominopelvic Metastases

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Adaptive Stereotactic Body Radiation — 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.

Study Details

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.

Key Dates

Start date

Aug 1, 2023

Status verified

Oct 2025

Primary completion

Jun 1, 2028

Completion

Jun 1, 2029

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Adaptive Stereotactic Body Radiation
  Simulation and treatment to be performed over 3-4 weeks per dose escalation

Primary Outcome Measure

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 ]

Central Contacts

• Tanu Singh
  12152141439
  [email protected]
• Joshua Meyer, MD
  215-728-2667
  [email protected]

Locations (1)

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