A Study of High-Dose Chemoradiation Using Biologically-Ba... | NCT02805179

NCT02805179

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
HUM00113549	Other Identifier	University of Michigan

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High Dose Chemoradiation	Experimental	Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide.	Radiation: High Dose Radiation Drug: Temozolomide

Name	Type	Description	Arm Group Labels	Other Names
High Dose Radiation	Radiation	Radiation will be delivered once daily for a total of 30 fractions, five days per week.	High Dose Chemoradiation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival at 12 Months	Percentage of patients alive at 12 months after completion of chemoradiation	12 months after completion of chemoradiation
Median Overall Survival	Median overall survival in months	Median follow-up time was 26 months

Secondary Outcomes

Measure	Description	Time Frame
Median Progression-free Survival	From start of RT until disease progression or death, or until date of last imaging follow-up, estimated using Kaplan-Meier. Progression is defined by any of the following: >= 25% increase in sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR non-enhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not due to comorbid events; appearance of any new lesions; clear progression of non-measurable lesions; or definite clinical deterioration not attributable to causes other than tumor, or to decrease in corticosteroid dose. When pathologic confirmation was unavailable, progression was defined as worsening enhancement based on imaging with or without adjunctive advanced imaging including perfusion MRI or magnetic resonance spectroscopy, when clinically indicated.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newly diagnosed histologically-confirmed supratentorial World Health Organization (WHO) grade IV gliomas including glioblastoma multiforme and gliosarcoma
Age 18 or older
Karnofsky performance status (a measure to quantify general well being and activities of daily life; scale ranges from 0 to 100 where 100 is perfect health) of greater than or equal to 70
Life expectancy of at least 12 weeks
Adequate bone marrow reserve (hemoglobin greater than or equal to 10, absolute neutrophil count greater than or equal to 1500, platelets greater than or equal to 100,000); acceptable liver function (total bilirubin less than or equal to 2.0 mg/dl, ALT (Alanine Aminotransferase)/AST (Aspartate Aminotransferase) less than or equal to 5 times the normal range); acceptable renal function (serum creatinine less than or equal to 2.0 mg/dl). Eligibility level for hemoglobin may be reached by transfusion.
Maximal contiguous volume of tumor based on high b-value diffusion MRI < 1/3 volume of brain
Patients must be registered within 6 weeks of most recent resection.
Patients must have signed a study-specific informed consent.

Exclusion Criteria:

Recurrent glioma, or tumor involving the brainstem or cerebellum. Prior low-grade glioma without prior RT, now with malignant progression are eligible.
Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted. Prior chemotherapy for a different cancer is allowable, except for Temozolomide or Bevacizumab.
Evidence of cerebrospinal fluid dissemination (positive cerebrospinal fluid cytology for malignancy or MRI findings consistent with CSF dissemination)
Evidence of severe concurrent disease requiring treatment
Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free for a minimum of 3 years (for example, carcinoma in situ of breast, oral cavity or cervix are all permissible)
Patients unable to undergo Magnetic Resonance Imaging exams (MRI) (i.e. patients with non-compatible devices such as cardiac pacemakers, other implanted electronic devices, metallic prostheses, or ferromagnetic prostheses (e.g. pins in artificial joints and surgical pins/clips) or unable to receive gadolinium for MRI, as per the standard UM Department of Radiology MRI screening criteria)
Patients treated with previous cranial or head/neck radiotherapy leading to radiation field overlap
Females of child-bearing potential must have a negative pregnancy test within 14 days prior to registration. Patients with reproductive potential must agree to use an effective contraceptive method during treatment.

Name	Affiliation	Role
Michelle Kim, M.D.	University of Michigan Rogel Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Hospital		Ann Arbor	Michigan	48109	United States

PubMed Identifier	Type	Citation	Retractions
9989517	Result	Lee SW, Fraass BA, Marsh LH, Herbort K, Gebarski SS, Martel MK, Radany EH, Lichter AS, Sandler HM. Patterns of failure following high-dose 3-D conformal radiotherapy for high-grade astrocytomas: a quantitative dosimetric study. Int J Radiat Oncol Biol Phys. 1999 Jan 1;43(1):79-88. doi: 10.1016/s0360-3016(98)00266-1.

Arm/Group Information

ID	Title	Description
FG000	All Participants	Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	High Dose Chemoradiation	Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival at 12 Months

Percentage of patients alive at 12 months after completion of chemoradiation

all eligible patients who completed dose-intensified chemo-radiation

Posted

Number

95% Confidence Interval

percentage of participants

12 months after completion of chemoradiation

ID	Title	Description
OG000	High Dose Chemoradiation	Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	All Enrolled Patients	Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

ID	Term
D055585	Physical Phenomena
D003606	Dacarbazine
D014226	Triazenes
D009930	Organic Chemicals