Standard versus specialized radiation therapy with chemotherapy to treat newly diagnosed glioblastoma (type of brain tumor)

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"Is specialized radiation therapy more effective than standard-dose radiation therapy with chemotherapy in treating glioblastoma?"
Age:
18 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
brain cancer, brain tumor, cancer
Type:
Radiation study, Phase 2
Investigator:
Description
This study looks at how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with chemotherapy (temozolomide) in patients with newly diagnosed glioblastoma (type of brain tumor). Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Chemotherapy drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.
This study requires
Blood tests
Biopsy of tumor after surgery
Chemotherapy (temozolomide) and radiation (standard or specialized) therapy administration
Who can participate?
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 14 days prior to step 2 registration

- The patient must have recovered from effects of surgery, postoperative infection, and other complications within 14 days prior to step 2 registration

- Documentation of steroid doses within 14 days prior to step 2 registration

- Karnofsky performance status >= 70 within 14 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

- CD4 lymphocyte count within 14 days prior to step 2 registration

- Negative serum pregnancy test obtained for females of child-bearing potential within 14 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 14 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)
Resources
Schedule
Study duration and period
Up to 12 months
Recruitment period
From Feb. 10, 2015
Location
UC Davis Comprehensive Cancer Center
2279 45th Street
Sacramento, CA 95817
Contact
Ruben Fragaso, MD PhD
Research Topic
Conditions:
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma

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