Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-06-05
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ablative Reirradiation
Reirradiation
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.
Interventions
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Reirradiation
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Baptist Health Foundation
UNKNOWN
Baptist Health South Florida
OTHER
Responsible Party
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Principal Investigators
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Michael Chuong, M.D.
Role: PRINCIPAL_INVESTIGATOR
Miami Cancer Institute at Baptist Health, Inc.
Locations
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Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Michael Chuong, M.D.
Role: primary
Carolina Rojas
Role: backup
References
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Hunt A, Das P, Minsky BD, Koay EJ, Krishnan S, Herman JM, Taniguchi C, Koong A, Smith GL, Holliday EB. Hyperfractionated abdominal reirradiation for gastrointestinal malignancies. Radiat Oncol. 2018 Aug 7;13(1):143. doi: 10.1186/s13014-018-1084-0.
Tao R, Tsai CJ, Jensen G, Eng C, Kopetz S, Overman MJ, Skibber JM, Rodriguez-Bigas M, Chang GJ, You YN, Bednarski BK, Minsky BD, Delclos ME, Koay E, Krishnan S, Crane CH, Das P. Hyperfractionated accelerated reirradiation for rectal cancer: An analysis of outcomes and toxicity. Radiother Oncol. 2017 Jan;122(1):146-151. doi: 10.1016/j.radonc.2016.12.015. Epub 2017 Jan 3.
Moningi S, Ludmir EB, Polamraju P, Williamson T, Melkun MM, Herman JD, Krishnan S, Koay EJ, Koong AC, Minsky BD, Smith GL, Taniguchi C, Das P, Holliday EB. Definitive hyperfractionated, accelerated proton reirradiation for patients with pelvic malignancies. Clin Transl Radiat Oncol. 2019 Aug 27;19:59-65. doi: 10.1016/j.ctro.2019.08.004. eCollection 2019 Nov.
Sadozye AH. Re-irradiation in Gynaecological Malignancies: A Review. Clin Oncol (R Coll Radiol). 2018 Feb;30(2):110-115. doi: 10.1016/j.clon.2017.11.013. Epub 2017 Dec 9.
Munoz F, Fiorica F, Caravatta L, Rosa C, Ferella L, Boldrini L, Fionda B, Alitto AR, Nardangeli A, Dionisi F, Arcangeli S, Di Marzo A, Pontoriero A, Donato V, Massaccesi M. Outcomes and toxicities of re-irradiation for prostate cancer: A systematic review on behalf of the Re-Irradiation Working Group of the Italian Association of Radiotherapy and Clinical Oncology (AIRO). Cancer Treat Rev. 2021 Apr;95:102176. doi: 10.1016/j.ctrv.2021.102176. Epub 2021 Mar 8.
Barsky AR, Reddy VK, Plastaras JP, Ben-Josef E, Metz JM, Wojcieszynski AP. Proton beam re-irradiation for gastrointestinal malignancies: a systematic review. J Gastrointest Oncol. 2020 Feb;11(1):187-202. doi: 10.21037/jgo.2019.09.03.
Abusaris H, Hoogeman M, Nuyttens JJ. Re-irradiation: outcome, cumulative dose and toxicity in patients retreated with stereotactic radiotherapy in the abdominal or pelvic region. Technol Cancer Res Treat. 2012 Dec;11(6):591-7. doi: 10.7785/tcrt.2012.500261. Epub 2012 May 7.
Related Links
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Miami Cancer Institute
Other Identifiers
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2023-CHU-001
Identifier Type: -
Identifier Source: org_study_id