Stereotactic Biopsy Split-Course Radiation Therapy in Diffuse Midline Glioma, SPORT-DMG Study
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|ClinicalTrials.gov Identifier: NCT05077735|
Recruitment Status : Recruiting
First Posted : October 14, 2021
Last Update Posted : March 9, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Diffuse Midline Glioma, H3 K27M-Mutant||Radiation: Hypofractionated Radiation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration||Phase 2|
I. To estimate the time to progression after the second hypofractionated radiation course of 25 Gy in 10 fractions in patients with diffuse midline glioma of the pons, calculated from date of diagnosis.
I. To evaluate the quality of life outcomes for patients with diffuse midline gliomas of the pons.
II. To estimate progression free survival intervals for patients after each hypofractionated radiation treatment course.
III. To evaluate the quality of life outcomes for parents of patients =< 18 years with the Functional Assessment of Cancer Therapy General (FACT-G) Family/Caregiver Questionnaire.
IV. To estimate the overall survival for patients with diffuse midline gliomas of the pons treated with planned multi-course hypofractionated radiation courses.
V. To report toxicities associated with hypofractionated, planned, multi-course radiation treatment for diffuse midline glioma of the pons.
Patients undergo hypofractionated radiation therapy (RT) over 10 fractions. Patients who achieve progression undergo up to 2 retreatment courses.
After completion of study treatment, patients are followed up at 1 month, every 2 months for year 1, every 3 months for year 2, then every 6 months for year 3.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stereotactic Biopsy Split-Course Radiation Therapy - Diffuse Midline Glioma (SPORT-DMG)|
|Actual Study Start Date :||October 6, 2021|
|Estimated Primary Completion Date :||October 15, 2024|
|Estimated Study Completion Date :||October 15, 2025|
Experimental: Treatment (hypofractionated RT)
Patients undergo hypofractionated RT over 10 fractions. Patients who achieve progression undergo up to 2 retreatment courses.
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- Time to progression [ Time Frame: From date of diagnosis to the date of radiographic or clinical progression following second course of hypofractionated radiation therapy, assessed up to 3 years ]The Wilcoxon Signed-Rank Tests for Non-Inferiority was utilized from PASS software for this design.
- Quality of Life Measurement [ Time Frame: Baseline up to 3 years ]Results from Pediatric Quality of Life Inventory Brain Tumor Module will be used to evaluate the quality of life outcomes in patients up to 18 years old and National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (FACT)-Brain Symptom Index-24 in patients more than 18 years old. Changes in raw score from baseline to each time-point will be assessed, in each of the physical and mental health domains. The Wilcoxon signed-rank test will be utilized to assess changes in raw scores. Mean change, along with standard deviation will be reported.
- Progression free survival [ Time Frame: From registration date to the earliest date of documentation of progression after each course of radiation therapy (RT) or death due to any cause, assessed up to 3 years ]The average progression free survival interval after each course of RT will be reported in months.
- FACT-General Family/Caregiver Questionnaire [ Time Frame: Up to 3 years ]Changes in raw score from baseline to each time-point will be assessed, in each of the physical and mental health domains. The Wilcoxon signed-rank test will be utilized to assess changes in raw scores. Mean change, along with standard deviation will be reported.
- Overall survival [ Time Frame: From registration date to death due to any cause, censoring patients alive at the date of last contact, assessed up to 3 years ]The distribution of overall survival will be estimated using method of Kaplan-Meier.
- Incidence of adverse events [ Time Frame: Up to 3 years ]The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||1 Year and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age >= 1 year(s) old (no maximum age)
Radiologic appearance of diffuse midline glioma of the pons, including diffuse infiltration of >= 50% of the pons on MRI, with or without extension to the midbrain and/or medulla oblongata with at least 1 of the 3 brainstem symptoms (cranial nerve deficit, long tract sign, or cerebellar sign)
- If all features of this clinicoradiologic criteria are met, then patients can continue on protocol with or without a biopsy
- If all features of this clinicoradiologic criteria are not met, patients must receive a brainstem lesion biopsy to be treated on protocol. If this cannot be completed, patients will be withdrawn from the study
- If biopsy has already been completed at an outside institution, the outside pathology report will be reviewed ahead of trial enrollment. The pathology specimen will then be sent to Mayo Clinic for further review, but will not delay study enrollment
- Able to undergo MRI Brain
- Negative urine pregnancy test completed =< 7 days prior to registration, for women of childbearing potential only
- Primary language of English or Spanish for patients and their caregiver
- Patient or caregiver willing and able to provide written informed consent
- Caregiver able to complete questionnaires by themselves or with assistance
- Willing to return to enrolling institution for follow-up during the active monitoring phase of the study
- Any patient who has received previous radiation to the brain
- Any patient who has received previous chemotherapy
- Any patient with a diagnosis of neurofibromatosis type 1 or 2 (NF1 or NF2)
Any of the following:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Other active malignancy =< 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer, breast cancer, prostate cancer, well-differentiated thyroid cancer, carcinoma-in-situ of the cervix
- NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
- Patients > 16 years with an Eastern Cooperative Oncology Group (ECOG) score >= 4 and patients =< 16 years with a Lansky play scale =< 20
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05077735
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Referral Office 855-776-0015 email@example.com|
|Principal Investigator: Danielle A. Cunningham, M.D.|
|Principal Investigator:||Danielle A Cunningham||Mayo Clinic in Rochester|
|Responsible Party:||Mayo Clinic|
|Other Study ID Numbers:||
NCI-2021-10010 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
|First Posted:||October 14, 2021 Key Record Dates|
|Last Update Posted:||March 9, 2023|
|Last Verified:||March 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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