Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03180502 : Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- STEP 1 REGISTRATION

- Tumor tissue must be available for submission for central pathology review

- Documentation from the enrolling site confirming the presence of IDH mutation and
1p/19q status; the provided information must document assays performed in clinical
laboratory improvement amendments (CLIA)-approved laboratories

- Appropriate stage for study entry based on the following diagnostic workup:

- History/physical examination within 60 days prior to registration

- Imaging of the brain within 60 days prior to registration

- Only English speaking patients are eligible to participate as the cognitive and
quality of life assessments are available only in English

- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry

- Karnofsky performance status of >= 70 within 60 days prior to registration

- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3

- Platelets >= 100,000 cells/mm^3

- Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve
hemoglobin [Hgb] >= 10.0 g/dl is acceptable)

- Bilirubin =< 1.5 upper limit of normal (ULN)

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN

- CD4 lymphocyte count is highly encouraged

- Women of childbearing age must have a negative serum pregnancy test within 14 days
prior to registration

- Post-operative magnetic resonance (MR) imaging must be obtained for radiation therapy
planning; enrolling sites are highly encouraged to obtain thin-slice volumetric fluid
attenuated inversion recovery (FLAIR) and T1 post contrast sequences for planning
purposes

- STEP 2 REGISTRATION

- The following baseline neurocognitive assessments must be completed and uploaded
within 27 calendar days prior to step 2 registration: HVLT-R, TMT, and COWA

- NOTE: Completed baseline neurocognitive assessments can be uploaded at the time
of step 1 registration

- The following baseline patient reported outcome assessments must be completed and
uploaded within 27 calendar days prior to Step 2 registration: MDASI-BT, LASA QOL,
WPAI

- Financial clearance for proton therapy treatment within 30 days following step 1
registration

- Centrally reviewed histologically proven diagnosis of supratentorial, Word Health
Organization (WHO) grade II or III astrocytoma, oligodendroglioma or oligoastrocytoma;
tissue must be submitted x calendar days after step 1 registration

- Documentation must be uploaded within 15 business days and will be verified by the
translational/pathology study co-chairs within 5 business days after receiving the
upload; the documentation should demonstrate 1) evaluation of known IDH1 and IDH2
mutational hotspots (sequencing is encouraged) evaluation of chromosomes 1p and 19q
copy number utilizing either fluorescence in situ hybridization (FISH) or other
suitable assay

Exclusion Criteria:

- Definitive clinical or radiologic evidence of metastatic disease; if applicable

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity
or cervix are permissible)

- Prior cranial radiotherapy or radiotherapy to the head and neck where potential field
overlaps would exist

- Prior chemotherapy or radiotherapy for any brain tumor

- Histologic diagnosis of glioblastoma (WHO grade IV) or pilocytic astrocytoma (WHO
grade I)

- Definitive evidence of multifocal disease

- Planned use of cytotoxic chemotherapy during radiation (only adjuvant temozolomide
therapy will be used on this protocol)

- Patients with infra-tentorial tumors are not eligible

- Prior history of neurologic or psychiatric disease believed to impact cognitive
function

- The use of memantine during or following radiation is NOT allowed

- Severe, active co-morbidity defined as follows:

- Unstable angina or congestive heart failure requiring hospitalization within 6
months prior to enrollment

- Transmural myocardial infarction within the last 6 months prior to step 2
registration; evidence of recent myocardial infarction or ischemia by the
findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram
(EKG) performed within 28 days prior to step 2 registration (Note: EKG to be
performed only if clinical suspicion of cardiac issue)

- New York Heart Association grade II or greater congestive heart failure requiring
hospitalization within 12 months prior to step 2 registration

- Serious and inadequately controlled arrhythmia at step 2 registration

- Serious or non-healing wound, ulcer or bone fracture or history of abdominal
fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy
or significant traumatic injury within 28 days prior to step 2 registration, with
the exception of the craniotomy for surgical resection

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of step 2 registration

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
note, however, that laboratory tests for coagulation parameters are not required
for entry into this protocol

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of step 2
registration

- Human immunodeficiency virus (HIV) positive with CD4 count < 200
cells/microliter; acquired immune deficiency syndrome (AIDS) based upon current
Centers for Disease Control and Prevention (CDC) definition; note, however, that
HIV testing is not required for entry into this protocol

- Any other severe immunocompromised condition

- Active connective tissue disorders, such as lupus or scleroderma, that in the
opinion of the treating physician may put the patient at high risk for radiation
toxicity

- End-stage renal disease (i.e., on dialysis or dialysis has been recommended)

- Any other major medical illnesses or psychiatric treatments that in the
investigator's opinion will prevent administration or completion of protocol
therapy

- Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI
compatible implant or foreign body, gadolinium allergy or renal dysfunction preventing
the patient from receiving gadolinium- institutional guidelines should be used to
determine if patients are at risk for renal dysfunction); note that patients with
severe claustrophobia are permitted on this study if they are willing and able to
undergo MRI with adequate sedation or anesthesia
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT03180502      |      Link to official Clinicaltrials.gov listing
Locations
Geneva, Illinois
Facility: Northwestern Medicine Cancer Center Delnor
Investigator: Vinai Gondi
Contact: Vinai Gondi Phone: 630-315-1918
Click HERE to send email to this center

Warrenville, Illinois
Facility: Northwestern Medicine Cancer Center Warrenville
Investigator: Vinai Gondi
Contact: Vinai Gondi Phone: 630-315-1918
Click HERE to send email to this center

Rochester, Minnesota
Facility: Mayo Clinic
Investigator: Anita Mahajan
Contact: Anita Mahajan Phone: 855-776-0015
Email not avaialable

Philadelphia, Pennsylvania
Facility: NRG Oncology
Investigator: David R. Grosshans
Contact: David R. Grosshans Phone: 713-792-3245
Email not avaialable




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