Temozolomide and Radiation Therapy With or Without Cediranib Maleate in Treating Patients With Newly Diagnosed Glioblastoma
Randomized, Phase II, Double-Blind, Placebo-Controlled Trial of Conventional Chemoradiation and Adjuvant Temozolomide Plus Cediranib Versus Conventional Chemoradiation and Adjuvant Temozolomide Plus Placebo in Patients With Newly Diagnosed Glioblastoma
6 other identifiers
interventional
261
1 country
105
Brief Summary
This randomized phase II trial studies temozolomide, radiation therapy, and cediranib maleate to see how well they work compared with temozolomide, radiation therapy, and a placebo in treating patients with newly diagnosed glioblastoma (a type of brain tumor). Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether temozolomide and radiation therapy are more effective when given with or without cediranib maleate in treating glioblastoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2010
Longer than P75 for phase_2
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2010
CompletedFirst Posted
Study publicly available on registry
February 4, 2010
CompletedStudy Start
First participant enrolled
February 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2015
CompletedResults Posted
Study results publicly available
September 19, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedJuly 26, 2022
May 1, 2022
5.8 years
February 3, 2010
July 28, 2016
June 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
6-month Progression-free Survival Rate
Six-month progression-free survival is the rate of patients who have NOT progressed at six months, where progressive disease is defined as any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. Progression will be determined by central review of MRI exams, assessed using MacDonald criteria for progression versus response on 2D T1 and T2 weighted images.
From randomization to 6 months.
Secondary Outcomes (3)
Overall Survival (OS)
From randomization to time of death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months.
Progression-free Survival (PFS)
From randomization to time of first progression or death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months.
Incidence of Grade 3+ Toxicities
From randomization to six months.
Study Arms (2)
Cediranib, TMZ, and RT
EXPERIMENTALCediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum.
Placebo, TMZ, and RT
ACTIVE COMPARATORPlacebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum.
Interventions
Undergo 3-dimensional conformal radiotherapy
Given PO
Undergo intensity-modulated radiation therapy
Given PO
Eligibility Criteria
You may qualify if:
- Histologically proven diagnosis of glioblastoma or gliosarcoma (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 size for analysis of MGMT status
- Patients must have at least 1 block of tumor tissue; submission of 2 blocks is strongly encouraged
- Cavitron ultrasonic aspirator (CUSA)-derived material is not allowed; fresh frozen tumor tissue acquisition is encouraged
- Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy is not allowed because it will not provide sufficient tissue for MGMT analysis
- The tumor tissue must be sent as soon as possible to maximize the likelihood of eligibility; tumor tissue may not be submitted later than 28 days after the surgical procedure, because tissue analysis will not be able to be performed in time for treatment to commence by the mandatory 6-week post-surgery outer limit; submission of tissue earlier than 28 days post-surgery is highly recommended
- The tumor must have a supratentorial component
- History/physical examination, including neurologic examination, within 14 days prior to step 2 registration
- The patient must have recovered from the effects of surgery, post-operative infection, and other complications before step 2 registration
- A diagnostic contrast-enhanced magnetic resonance imaging (MRI) of the brain must be performed preoperatively and postoperatively prior to step 1 registration; the postoperative scan must be performed within 28 days prior to step 1 registration
- Documentation of steroid doses/concurrent medications within 14 days prior to step 2 registration
- Karnofsky performance status \>= 70 within 14 days prior to step 2 registration
- Complete blood count (CBC)/differential obtained within 14 days prior to step 2 registration on study, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) \>= 1,800 cells/mm\^3
- Platelets \>= 100,000 cells/mm\^3
- +13 more criteria
You may not qualify if:
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for \>= 3 years; (for example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible)
- Recurrent or multifocal malignant gliomas
- Metastases detected below the tentorium or beyond the cranial vault
- Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide or cediranib); 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 and/or congestive heart failure requiring hospitalization
- Transmural myocardial infarction within the last 6 months
- 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 of step 2 registration
- New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration
- History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months
- Serious and inadequately controlled cardiac arrhythmia
- Significant vascular disease (e.g., aortic aneurysm, 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 or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to step 2 registration, with the exception of the craniotomy for tumor resection
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- NRG Oncologycollaborator
- Radiation Therapy Oncology Groupcollaborator
Study Sites (105)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
The Kirklin Clinic at Acton Road
Birmingham, Alabama, 35243, United States
Arizona Oncology Services Foundation
Scottsdale, Arizona, 85260, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Saint Joseph Hospital - Orange
Orange, California, 92868, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Yale University
New Haven, Connecticut, 06520, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Bay Medical Center
Panama City, Florida, 32401, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Radiation Oncology Associates PC
Fort Wayne, Indiana, 46804, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, 66208, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Ascension Saint John Hospital
Detroit, Michigan, 48236, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Sparta Cancer Treatment Center
Sparta, New Jersey, 07871, United States
University of Rochester
Rochester, New York, 14642, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Summa Health System - Akron Campus
Akron, Ohio, 44304, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Summa Health System - Barberton Campus
Barberton, Ohio, 44203, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University Hospitals Portage Medical Center
Ravenna, Ohio, 44266, United States
UH Seidman Cancer Center at Salem Regional Medical Center
Salem, Ohio, 44460, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
Cancer Treatment Center
Wooster, Ohio, 44691, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, 74136, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Jefferson Abington Hospital
Abington, Pennsylvania, 19001, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, 15301, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Saint George Regional Medical Center
St. George, Utah, 84770, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
Compass Oncology Vancouver
Vancouver, Washington, 98684, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wendy Seiferheld, M.S.
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Tracy T Batchelor
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2010
First Posted
February 4, 2010
Study Start
February 26, 2010
Primary Completion
December 6, 2015
Study Completion
May 20, 2022
Last Updated
July 26, 2022
Results First Posted
September 19, 2016
Record last verified: 2022-05