Ablative Stereotactic MR-Guided Adaptive Reirradiation

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

11 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This research study will enroll people who have cancer in their abdomen or pelvis that was treated previously with radiation therapy. The purpose of this research study is to test the safety and possible harms of treating tumors in these regions with another round of radiation therapy, called reirradiation or "reRT." The researchers want to find out what effects (good and bad) reRT has in people with cancer in the abdomen and pelvis.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• A primary or metastatic lesion in the abdomen or pelvis for which reirradiation will be delivered. There is no maximum lesion size.
• Single course of prior radiation therapy with prescribed equivalent dose in 2 Gy fractions (EDQ210) of at least 40 Gy.
• 50% isodose line of the prior radiation therapy course is expected to overlap at minimum the 50% isodose line of the radiation therapy delivered in this study.
• At least 6 months from completion of prior radiation therapy to initiation of study therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Life expectancy at least 6 months.
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if it is the participant's preferred method. Should a participant become pregnant or suspect pregnancy while participating in this study, the treating physician must be informed immediately.
• Concurrent hormonal therapy or immunotherapy such as immune checkpoint inhibitor is allowed

Exclusion Criteria:

• Contraindication to having an MRI scan.
• Lesion that would receive study therapy arises from or invades a gastrointestinal (GI) luminal organ (a lesion abutting but not invading a GI luminal organ is permitted)
• Lesion that would receive study therapy is not located in the abdomen or pelvis.
• \> 1 course of overlapping radiation therapy delivered to the abdomen or pelvis.
• \< 70% of the gross tumor volume (GTV) receives at least the 95% of the prescribed dose on the original plan using the simulation day anatomy.
• More than 1 lesion in the abdomen or pelvis that requires reirradiation.
• History of inflammatory bowel disease.
• Unable to acquire DICOM radiation therapy treatment plan from the prior radiation therapy.
• Unresolved grade 2+ toxicity (Common Terminology Criteria for Adverse Events version 5.0) from previous anti-cancer therapy.
• Any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of participant safety or study results.
• Individuals who are pregnant.
• Chemotherapy given within 1 week prior to or following reirradiation.
• Vascular endothelial growth factor (VEGF) inhibitor given within 8 weeks prior to or following reirradiation

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Baptist Health South Florida

Study start

Jun 5, 2024 Actual

Primary completion

Aug 20, 2026 Actual

Study completion

Aug 20, 2026 Actual

First posted

May 3, 2024 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.