Recruiting
Phase 1

Adaptive Radiation

Sponsor:

Fox Chase Cancer Center

Code:

NCT05880667

Conditions

Neoplasm - Soft Tissue Pelvis Malignant Secondary

Malignant Neoplasm of Stomach

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Adaptive Stereotactic Body Radiation

Study Details

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.

Conditions

Neoplasm - Soft Tissue Pelvis Malignant Secondary

Malignant Neoplasm of Stomach

Study ID

NCT05880667

Start date

Aug 1, 2023

Status verified date

Oct, 2025

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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.
2. Age > 18 years.
3. ECOG performance status 0 or 1
4. Estimated survival of >/= 12 months
5. 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
6. 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:

1. 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.
2. Subjects must not be receiving any other investigational agents.
3. Subjects must not have known peritoneal carcinomatosis visible on imaging.
4. Subjects must not have known active solid tumors on imaging outside of abdomen/pelvis noted on screening imaging
5. Subjects must not have 6 or more active metastatic sites.
6. Subjects must not have had prior radiotherapy to any target metastatic lesion. Prior radiotherapy to non-target sites is allowed.
7. 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.
8. Any condition or significant co-morbidity that prevents safe delivery of SBRT per the discretion of the treating physician(s).
9. Subjects must not be pregnant or breast-feeding. Refer to section 4.4 for further detail.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adaptive Stereotactic Body Radiation

Simulation and treatment to be performed over 3-4 weeks per dose escalation

Interventions

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.

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 and Locations

Locations

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Principal Investigator:

Joshua E. Meyer

More Information

Sponsor

Fox Chase Cancer Center

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fox Chase Cancer Center on 2025-10-29.