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Trial Title:
Ablative Stereotactic MR-Guided Adaptive Reirradiation
NCT ID:
NCT06397573
Condition:
Abdominal Cancer
Pelvic Cancer
Conditions: Official terms:
Pelvic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Reirradiation
Description:
Ablative reirradiation of 50 Gy in 5 fractions (5 sessions) that will occur once per day,
either for 5 days in a row, or every other day.
Arm group label:
Ablative Reirradiation
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.
Criteria for 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.
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Miami Cancer Institute at Baptist Health South Florida
Address:
City:
Miami
Zip:
33176
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Chuong, M.D.
Phone:
786-596-2000
Email:
MichaelChu@baptisthealth.net
Contact backup:
Last name:
Carolina Rojas
Phone:
(786) 527-8543
Email:
CarolinaRoj@baptisthealth.net
Investigator:
Last name:
Michael Chuong, MD
Email:
Principal Investigator
Start date:
June 5, 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Baptist Health South Florida
Agency class:
Other
Collaborator:
Agency:
Baptist Health Foundation
Agency class:
Other
Source:
Baptist Health South Florida
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06397573
https://cancer.baptisthealth.net/miami-cancer-institute
