Clinical trial NCT06397573: Ablative Stereotactic MR-Guided Adaptive Reirradiation
Official title: Phase 1 Trial of Ablative Stereotactic MR-Guided Adaptive Reirradiation for Abdominal and Pelvic Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Cancer
Pelvic Cancer
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
Collaborators: name: Baptist Health Foundation
First posted: 2024-05-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Grade 3 or higher acute toxicity
timeFrame: 1 year
measure: Grade 5 toxicity
timeFrame: 1 year
Secondary outcomes:
measure: Freedom from local progression (FFLP)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 1 year
measure: Grade 3 or higher late toxicity
timeFrame: 1 year
measure: Quality of life (QOL)
timeFrame: 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health South Florida
state: Florida
Study officials:
affiliation: Miami Cancer Institute at Baptist Health, Inc.
name: Michael Chuong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.