Ablative Stereotactic MR-Guided Adaptive Reirradiation

Not Applicable

Recruiting

• Conditions: Abdominal Cancer; Pelvic Cancer
• Interventions: Radiation: Reirradiation

• Registration Number: NCT06397573
• Lead Sponsor: Baptist Health South Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-03
• Study Start: 2024-06-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ablative Reirradiation	Reirradiation	-

Primary Outcome Measures

Name	Time	Method
Grade 5 toxicity	1 year	Number of participants who experience Grade 5 toxicity (graded per CTCAE) possibly, probably, or definitely related to reRT.
Grade 3 or higher acute toxicity	1 year	Number of participants who experience Grade 3 or higher acute toxicity \[graded per Common Terminology Criteria for Adverse Events (CTCAE)\] possibly, probably, or definitely related to reRT.

Secondary Outcome Measures

Name	Time	Method
Freedom from local progression (FFLP)	1 year	FFLP is defined as the duration of time from baseline to progressive disease (PD) in the re-irradiated lesion or death of any cause, whichever occurs first. Response to treatment will be assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Grade 3 or higher late toxicity	1 year	Number of participants who experience Grade 3 or higher acute toxicity \[graded per Common Terminology Criteria for Adverse Events (CTCAE)\] possibly, probably, or definitely related to reRT that occurs at least 90 days after reRT therapy has ended.
Overall survival (OS)	1 year	OS is defined as the defined as the duration of time from baseline to death of any cause, or date of last follow-up, whichever occurs first.
Quality of life (QOL)	1 year	QOL will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. The FACT-G is a 27-item questionnaire measuring physical, social, emotional, and functional well-being. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much), with a possible range of 0-108 points. Negatively worded items are reverse scored prior to summing so that higher scores indicate better QOL.

Trial Locations

Locations (1)

Miami Cancer Institute at Baptist Health South Florida; 🇺🇸 Miami, Florida, United States