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Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

Phase 3
18 Years
Open (Enrolling)
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

Thank you

Trial Information

Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma


I. To determine whether the addition of bevacizumab to temozolomide and radiotherapy
improves efficacy, as measured by progression-free (PFS) and/or overall survival (OS), in
patients with newly diagnosed glioblastoma. (Gliosarcoma closed to accrual as of 07/13/10).

II. To assess the association between overall survival and K^trans change from T1 to T2.

III. To assess the association between OS and spin echo CBV change from T1 to T2.


I. To determine whether the tumor molecular profile conferring a mesenchymal/angiogenic
phenotype is associated with a selective increase in benefit from the addition of
bevacizumab to temozolomide and radiotherapy, as measured by OS or PFS, in these patients.

II. To compare the toxicities of chemoradiotherapy with bevacizumab vs conventional
chemoradiotherapy in these patients.

III. To assess the association between PFS and K^trans change from T1 to T2. IV. To assess
the association between PFS and spin echo CBV change from T1 to T2.

V. To assess the association between values of K^trans and spin echo CBV measured separately
at T0 and at T1, and OS and PFS.

VI. To assess the association between OS and K^trans changes from T0 to T1 and from T2 to

VII. To assess the association between OS and spin echo CBV changes from T0 to T1 and from
T2 to T3.

VIII. To assess the association between OS and apparent diffusion coefficient (ADC) change
from T0 to T1.

IX. To assess the association between OS and ADC change from T1 to T2. X. To assess the
association between PFS and ADC change from T0 to T1. XI. To assess the association between
PFS and ADC change from T1 to T2. XII. To assess the association between T1 values of ADC
and OS and PFS. XIII. To assess the association between change in lesion size between T1 and
T3, as measured by advanced MRI, and OS and PFS.


I. To determine the differential acute effects associated with the addition of bevacizumab
to temozolomide and radiation, as compared to the conventional arm, on measures of
neurocognitive function (NCF), health-related quality of life (HR-QOL), and symptoms during
radiation and across the longitudinal progression-free interval.

II. To determine the relationship of NCF, HR-QOL, and symptoms, with PFS and OS.

III. To determine the association between tumor molecular profile (i.e.,
mesenchymal/angiogenic phenotype and proneural phenotype) and NCF, HR-QOL, and symptoms.

IV. To describe the association between HR-QOL as measured by the EORTC-QL30/BCM20 and mean
symptom severity as measured by the MDASI-BT in patients enrolled in this study.

V. To evaluate the relationship between self-reported NCF and objectively measured tests of

VI. To assess the association between measures of change in enhancing tumor size at week 22
and OS in patients treated with chemoradiotherapy with and without bevacizumab.

VII. To assess the association between measures of change in T2-based tumor size at week 22
and OS in patients treated with these regimens.

VIII. To assess the association between changes in ADC values and OS in patients treated
with these regimens.

IX. To assess the association between measures of change in enhancing tumor size at week 22
and OS in patients with glioma receiving chemoradiotherapy with and without bevacizumab.

X. To assess the association between measures of change in T2-based tumor size at week 22
and OS in patients with glioma receiving chemoradiotherapy with and without bevacizumab.

XI. To assess the association between changes in ADC values and OS in patients with glioma
receiving chemoradiotherapy with and without bevacizumab.

OUTLINE: This is a multicenter study. Patients are stratified according to MGMT methylation
status (methylated vs unmethylated vs invalid) and tumor molecular profile metagene score
(favorable vs unfavorable vs undetermined). Patients are randomized to 1 of 2 treatment

ARM I: Patients undergo radiotherapy (intensity-modulated radiotherapy or 3-dimensional
conformal radiotherapy) once daily 5 days a week for 6 weeks and receive concurrent oral
temozolomide once daily for up to 7 weeks. Beginning 4 weeks after completion of
chemoradiotherapy, patients receive adjuvant oral temozolomide once daily on days 1-5.
Treatment with adjuvant temozolomide repeats every 28 days for up to 12 courses in the
absence of disease progression or unacceptable toxicity. Patients also receive placebo IV
over 30-90 minutes once every 2 weeks beginning in week 4 of chemoradiotherapy and
continuing until the completion of adjuvant temozolomide.

ARM II: Patients undergo chemoradiotherapy and receive adjuvant temozolomide as in arm I.
Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning in week
4 of chemoradiotherapy and continuing until the completion of adjuvant temozolomide.

Some patients may undergo Dynamic Susceptibility-Contrast MRI (DSC-MRI) and Dynamic
Contrast-Enhanced (DCE-MRI) imaging at baseline, periodically during the study, and after
completion of treatment.

After completion of study treatment, patients are followed every 3 months for 1 year, every
4 months for 1 year, and then every 6 months thereafter.

Inclusion Criteria:

- Histologically confirmed glioblastoma (gliosarcoma closed to accrual as of 07-13-10)

- WHO grade IV disease

- Tumor must have a supratentorial component

- Has undergone partial or complete surgical resection of tumor within the past 3-5

- Diagnosis must be made by surgical excision (not by stereotactic biopsy)

- No significant postoperative hemorrhage, defined as > 1 cm diameter of blood in
the tumor cavity by MRI or CT scan

- Has ≥ 1 block of tumor tissue of sufficient size available for analysis of MGMT
status and determination of molecular profile

- At least 1 cm³ of tissue composed primarily of tumor must be present

- No CUSA (Cavitron ultrasonic aspirator)-derived material

- No recurrent or multifocal malignant glioma

- No metastases detected below the tentorium or beyond the cranial vault

- Karnofsky performance status 70-100%

- Absolute neutrophil count ≥ 1,800/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)

- ALT and AST ≤ 3 times normal

- Bilirubin ≤ 2.0 mg/dL

- PT/INR < 1.4 (for patients not on warfarin)

- Creatinine ≤ 1.7 mg/dL

- Urine protein: creatinine ratio < 0.5 OR 24-hour urine protein < 1,000 mg

- BUN ≤ 30 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 6 months after
completion of study treatment

- Systolic blood pressure (BP) ≤ 160 mm Hg or diastolic BP ≤ 90 mm Hg

- No evidence of acute cardiac ischemia by electrocardiogram

- No other invasive malignancy within the past 3 years, except for nonmelanomatous skin
cancer or carcinoma in situ of the breast, oral cavity, or cervix

- No severe, active comorbidity, including any of the following:

- Unstable angina and/or congestive heart failure within the past 6 months

- Transmural myocardial infarction within the past 6 months

- Evidence of recent myocardial infarction or ischemia as indicated by ST
elevations of ≥ 2 mm by EKG

- New York Heart Association class II-IV congestive heart failure requiring
hospitalization within the past 12 months

- Stroke, cerebral vascular accident, or transient ischemic attack within the past
6 months

- Serious, inadequately controlled cardiac arrhythmia

- Significant vascular disease (e.g., aortic aneurysm or history of aortic
dissection) or clinically significant peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Serious or non-healing wound, ulcer, or bone fracture

- Abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or
significant traumatic injury within the past 28 days

- Acute bacterial or fungal infection requiring IV antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- AIDS based on current CDC definition

- Active connective tissue disorders (e.g., lupus or scleroderma) that, in the
opinion of the treating physician, may place the patient at high risk for
radiation toxicity

- Any other major medical illness or psychiatric impairment that, in the opinion
of the investigator, would preclude study drug administration or completion of
study therapy

- Recovered from prior surgery

- No prior chemotherapy or radiosensitizers for cancer of the head and neck region

- Prior chemotherapy for a different cancer is allowed

- No prior temozolomide or bevacizumab

- No prior Gliadel wafers or any other intratumoral or intracavitary treatment

- No prior radiotherapy to the head and neck (except for T1 glottic cancer) resulting
in overlap of radiotherapy fields

- More than 28 days since prior major surgical procedure or open biopsy other than
craniotomy for tumor resection

- More than 30 days since prior and no concurrent treatment on another therapeutic
clinical trial

- No concurrent growth factors to induce elevations in neutrophil count for the
purposes of administration of temozolomide on the scheduled dosing interval; to allow
treatment with temozolomide at a higher dose; or to avoid interruption of the
treatment during concurrent radiotherapy

- No concurrent erythropoietin

- No concurrent tumor debulking surgery, other chemotherapy, immunotherapy, biologic
therapy, or additional stereotactic boost radiotherapy

- No other concurrent investigational drugs during the "blinded phase" of the study

- Concurrent full-dose anticoagulants (e.g., warfarin or low molecular weight heparin)
allowed provided both of the following criteria are met:

- No active bleeding or pathological condition that carries a high risk of
bleeding (e.g., tumor involving major vessels or known varices)

- In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a
stable dose of low molecular weight heparin

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

Estimated using the Kaplan-Meier method and differences between treatment arms will be tested in the log rank test (Mantel 1966).

Outcome Time Frame:

From randomization to the date of death due to any cause or otherwise, the last follow-up date on which the patient was reported alive, assessed up to 2 years

Safety Issue:


Principal Investigator

Mark Gilbert

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiation Therapy Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

Related Keywords:

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Glioblastoma
  • Gliosarcoma



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