Radiothérapie en régime fractionné par biopsie stéréotaxique dans le gliome diffus de la ligne médiane, étude SPORT-DMG
Radiothérapie fractionnée par biopsie stéréotaxique - Gliome diffus de la ligne médiane (SPORT-DMG)
This phase II trial studies the clinical outcomes of hypofractionated radiation therapy in patients with diffuse midline gliomas. This study aims to change the way radiation is delivered, from giving 6 weeks of radiation all at once to giving 2 weeks of radiation. This may determine if there is a difference in the outcome of the treatment, and most importantly, the patients' quality of life.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
PRIMARY OBJECTIVE:
I. To determine that 10-month overall survival (OS) rate for the hypofractionated radiation course of 25 Gy in 10 fractions in patients with diffuse midline glioma of the pons is superior to the low-end historical control (Survival rate of 40% at 10 months when calculating from time of enrollment) based on the current standard of care (54 GY in 30 fractions).
SECONDARY OBJECTIVES:
I. To evaluate the quality of life outcomes for patients with diffuse midline gliomas of the pons.
II. To estimate the time to progression after the second hypofractionated radiation course of 25 Gy in 10 fractions, calculated from date of registration and separately from primary tumor diagnosis date.
III. To estimate progression free survival intervals for patients after each hypofractionated radiation treatment course.
IV. 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.
V. To estimate the overall survival from date of enrollment to death and from primary tumor diagnosis date to death.
VI. To report toxicities associated with hypofractionated, planned, multi-course radiation treatment for diffuse midline glioma of the pons.
OUTLINE:
Patients undergo hypofractionated radiation therapy (RT) over 10 fractions. Patients who experience progression undergo up to 2 retreatment courses. Patients undergo magnetic resonance imaging (MRI) and computed tomography (CT) scan throughout the study.
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Arizona
-
Phoenix, Arizona, États-Unis, 85054
- Mayo Clinic Hospital in Arizona
-
-
Minnesota
-
Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic in Rochester
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
- NOTE: All novel therapeutic interventions, including but not limited to dordaviprone, are allowed for patients who enroll on the clinical trial
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Treatment (hypofractionated RT)
Patients undergo hypofractionated RT over 10 fractions. Patients who achieve progression undergo up to 2 retreatment courses. Patients undergo MRI and CT scan throughout the study. |
Undergo MRI
Autres noms:
Ancillary studies Undergo hypofractionated radiation therapy
Autres noms:
Undergo CT scan
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival (OS) at 10 months
Délai: At 10 months
|
OS is defined as the time from date of study registration until death due to any cause, assessed at 19 months. |
At 10 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to second progression
Délai: Up to 6 years
|
Defined as the time date of registration or primary tumor diagnosis to the date of radiographic, clinical progression, or death following second course of hypofractionated radiation therapy. |
Up to 6 years
|
|
Quality of Life Measurement - PedsQL (children under 18)
Délai: Baseline up to 6 years
|
Results from Pediatric Quality of Life Inventory (PedsQL) Brain Tumor Module will be used to evaluate the quality of life outcomes in patients up to 18 years old. PedsQL™ assessments include 23 items answered on aLikert response scale (0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem) for each item. |
Baseline up to 6 years
|
|
Quality of Life Measurement - NFBrSI-24
Délai: Baseline up to 6 years
|
The National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT)-Brain Symptom Index-24 (NFBrSI-24) will be used 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 NFBrSI-24 consists of 24 questions assessing symptoms over the past 7 days. Items are scored on a 5-point Likert type scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). |
Baseline up to 6 years
|
|
Progression free survival
Délai: Up to 6 years
|
The average progression free survival interval after each course of RT will be reported in months. Progression free survival is defined as the time from registration date to the earliest date of documentation of progression after each course of radiation therapy (RT) or death due to any cause. |
Up to 6 years
|
|
FACT-General Family/Caregiver Questionnaire (FACT-G)
Délai: Up to 6 years
|
Changes in raw score from baseline to each time-point will be assessed in each of the physical and mental health domains. The FACT-G contains 27 questions within 4 subscale domains [Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being] related to health-related quality of life (QOL) in the past 7 days, with higher scoring indicating better QOL. |
Up to 6 years
|
|
Overall survival
Délai: Up to 6 years
|
Overall survival is defined as the time from registration date to death due to any cause. Patients alive at the date of last contact will be censored. |
Up to 6 years
|
|
Incidence of adverse events
Délai: Up to 6 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. |
Up to 6 years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Roman O. Kowalchuk, MD, Mayo Clinic in Rochester
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Techniques d'investigation
- Thérapeutique
- Phénomènes physiques
- Techniques de chimie, analytique
- Analyse du spectre
- Phénomènes électromagnétiques
- Phénomènes magnétiques
- Radiothérapie
- Rayonnement électromagnétique
- Rayonnement, ionisant
- Fractionnement de dose, rayonnement
- Dose de radiothérapie
- Radiation
- Spectroscopie de résonance magnétique
- Rayons X
- Hypofractionnement de la dose de rayonnement
Autres numéros d'identification d'étude
- GMROR2162
- 21-000069 (Autre identifiant: Mayo Clinic Institutional Review Board)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .