Reirradiation for abdominal and pelvic cancer

Phase 1 Trial of Ablative Stereotactic MR-Guided Adaptive Reirradiation for Abdominal and Pelvic Tumors

This study tests whether a second round of radiation treatment can be safely given to people with abdominal or pelvic cancer who have already had radiation before, to see how it affects their tumors and health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Baptist Health South Florida (Academic / other)
• Drugs / interventions: Chemotherapy, immunotherapy, radiation
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT06397573 on ClinicalTrials.gov

What this trial studies

This research focuses on patients with abdominal or pelvic cancer who have previously undergone radiation therapy. The study aims to evaluate the safety and potential side effects of a second round of radiation treatment, known as reirradiation or reRT. Participants will receive this treatment to assess its effects on their tumors and overall health. The study will monitor both the positive and negative outcomes associated with this approach.

Who should consider this trial

Good fit: Ideal candidates include individuals with primary or metastatic lesions in the abdomen or pelvis who have previously received radiation therapy.

Not a fit: Patients who have not undergone prior radiation therapy or those with lesions outside the specified regions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with recurrent abdominal or pelvic cancer who have limited treatment alternatives.

How similar studies have performed: While there is ongoing research in reirradiation, this specific approach using MR-guided adaptive techniques is relatively novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Miami, Florida

• Miami Cancer Institute at Baptist Health South Florida — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Michael Chuong, M.D. — Miami Cancer Institute at Baptist Health, Inc.
• Study coordinator: Michael Chuong, M.D.

Conditions Abdominal Cancer; Pelvic Cancer