Clinical Trial Details
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[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.]

NCT02179086 : Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- PRIOR TO STEP 1 REGISTRATION

- A diagnostic contrast-enhanced magnetic resonance imaging (MRI) (no other scan type
allowed) of the brain must be performed postoperatively within 72 hours of resection;
the enhancing tumor must have a maximal diameter of 5 cm; the tumor diameter will be
the greatest diameter as measured on the contrast-enhanced postoperative MRI and will
include residual disease and/or the postoperative surgical cavity as appropriate; for
cases where residual disease or postoperative surgical cavity is NOT identifiable
(e.g., polar glioblastomas [GBMs] where a polar lobectomy is performed), the patient
will be excluded from the trial

- The GBM tumor must be located in the supratentorial compartment only (any component
involving the brain stem or cerebellum is not allowed)

- Patients must provide study-specific informed consent prior to step 1 registration

- PRIOR TO STEP 2 REGISTRATION

- Histologically proven diagnosis of glioblastoma (World Health Organization [WHO] grade
IV) confirmed by central review prior to step 2 registration

- Tumor tissue that is determined by central pathology review prior to step 2
registration to be of sufficient quantity for analysis of
O6-methylguanin-DNA-methyltransferase (MGMT) status

- Patients must have at least 1 block of tumor tissue; submission of 2 blocks is
strongly encouraged to maximize the chances of eligibility; at least 1 cubic
centimeter of tissue composed primarily of tumor must be present

- Diagnosis must be made by surgical excision, either partial or complete;
stereotactic biopsy or cavitron ultrasonic suction aspirator (CUSA) technique are
not allowed

- History/physical examination within 28 days prior to step 2 registration

- The patient must have recovered from effects of surgery, postoperative infection, and
other complications within 28 days prior to step 2 registration

- Documentation of steroid doses within 28 days prior to step 2 registration

- Karnofsky performance status >= 70 within 28 days prior to step 2 registration

- Age >= 18

- Absolute neutrophil count (ANC) >= 1,800 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

- Negative serum pregnancy test obtained for females of child-bearing potential within
28 days prior to step 2 registration

Exclusion Criteria:

- 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 all permissible)

- Recurrent or multifocal malignant gliomas

- Any site of distant disease (for example, drop metastases from the GBM tumor site)

- Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note
that prior chemotherapy for a different cancer is allowable (except temozolomide)

- Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are
not permitted

- Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in
overlap of radiation fields

- Severe, active co-morbidity, defined as follows:

- Unstable angina at step 2 registration

- 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

- 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

- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
Control and Prevention (CDC) definition; note, however, that human
immunodeficiency virus (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 (ie, 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

- Pregnancy or women of childbearing potential and men who are sexually active and not
willing/able to use medically acceptable forms of contraception

- Patents treated on any other therapeutic clinical protocols within 30 days prior to
step 2 registration

- Inability to undergo MRI (e.g., due to safety reasons, such as presence of a
pacemaker, or severe claustrophobia)

- Postoperative tumor plus surgical bed size exceeds 5 cm in maximum diameter.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02179086      |      Link to official Clinicaltrials.gov listing
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