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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablative Reirradiation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reirradiation | Radiation | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3 or higher acute toxicity | 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. | 1 year |
| Grade 5 toxicity | Number of participants who experience Grade 5 toxicity (graded per CTCAE) possibly, probably, or definitely related to reRT. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from local progression (FFLP) | 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). | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Chuong, M.D. | Miami Cancer Institute at Baptist Health, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Cancer Institute at Baptist Health South Florida | Miami | Florida | 33176 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30086784 | Background | 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. | |
| 28057329 | Background | 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. |
| Label | URL |
|---|---|
| Miami Cancer Institute | View source |
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| ID | Term |
|---|---|
| D010386 | Pelvic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069475 | Re-Irradiation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D019233 | Retreatment |
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| Overall survival (OS) |
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. |
| 1 year |
| Grade 3 or higher late toxicity | 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. | 1 year |
| Quality of life (QOL) | 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. | 1 year |
| 31517071 | Background | 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. |
| 29233573 | Background | 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. |
| 33743409 | Background | 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. |
| 32175122 | Background | 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. |
| 22568625 | Background | 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. |