RECRUITING

Ablative Stereotactic MR-Guided Adaptive Reirradiation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-05

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06397573

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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. * Uncontrolled brain metastases, spinal cord compression, or leptomeningeal carcinomatosis. * 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

Inclusion Criteria

Exclusion 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

* 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.
* Uncontrolled brain metastases, spinal cord compression, or leptomeningeal carcinomatosis.
* 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

Contacts and Locations

Study Contact

Michael Chuong, M.D.

CONTACT

(786) 596-2000

MichaelChu@baptisthealth.net

Carolina Rojas

CONTACT

(786) 527-8543

CarolinaRoj@baptisthealth.net

Principal Investigator

Michael Chuong, M.D.

PRINCIPAL_INVESTIGATOR

Miami Cancer Institute at Baptist Health, Inc.

Study Locations (Sites)

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, 33176

United States

Collaborators and Investigators

Sponsor: Baptist Health South Florida

Michael Chuong, M.D., PRINCIPAL_INVESTIGATOR, Miami Cancer Institute at Baptist Health, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-05

Study Completion Date2027-06

Study Record Updates

Study Start Date2024-06-05

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Abdominal Cancer
Pelvic Cancer