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  1. Home
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  3. Baptist Research Institute
  4. Brain and Spine Tumors
  5. Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

Study Name

Radiation therapy uses high-energy x-rays to kill tumor cells. 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. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

Study Description

Brain and Central Nervous System Tumors

Condition

Recruiting

Status

Summary

Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

Brief TitleShort description of the protocol intended for the lay public. Include a brief statement of the study hypothesis.

This study is currently recruiting participants.

Recruitment StatusIndicates the current stage of a clinical study and whether it is or will be open for enrollment.

Alliance for Clinical Trials in Oncology

SponsorThe sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Alliance for Clinical Trials in Oncology

Information provided byThe contents of the study record are provided by this organization or person. This sponsor, sponsor-investigator, or sponsor-designated principal investigator is responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information.

NCT00887146

ClinicalTrials.gov IdentifierA unique identification code is given to each clinical study registered on ClinicalTrials.gov. Because the format is the letters "NCT" followed by an 8-digit number (for example, NCT00000419), this identifier is also known as the NCT Number.

April 22, 2009

First ReceivedThe First Received date is the date that summary clinical study protocol information was first submitted to the ClinicalTrials.gov registry.

April 6, 2018

Last UpdatedThe Last Updated date is the most recent date that changes to a study record were submitted to ClinicalTrials.gov.

April 2018

Last VerifiedThe Last Verified date is the most recent date that all of a clinical study's information on ClinicalTrials.gov was confirmed as accurate and current.

Tracking Information

April 22, 2009

First Received DateThe First Received date is the date that summary clinical study protocol information was first submitted to the ClinicalTrials.gov registry.

April 6, 2018

Last Updated DateThe Last Updated date is the most recent date that changes to a study record were submitted to ClinicalTrials.gov.

September 2009

Start DateThe date that the enrollment of participants for a clinical study begins

Estimated Primary Completion Date The date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated.

  • Progression-free survival [ Time Frame: Time from study registration to time of tumor progression or death due to any cause, whichever comes first, assessed up to 16 years ] [ Designated as safety issue:  ]
    The distribution of progression free survival for Arms A and B will be estimated using the Kaplan-Meier method. The hazard ratios and median progression free survival (PFS) will be estimated with their confidence intervals. The Cox proportional hazards model will be used to assess whether the distributions of progression survival times differ with respect to treatment regimen having adjusted for all stratification factors (cooperative groups, age, and performance score). Both non-inferiority and superiority will be tested in this trial for the primary goal and no multiple-comparison adjustment will be considered.

Current Primary Outcome Measures Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.

Same as current

Original Primary Outcome Measures Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.

Click [ HERE ] for a complete list of historical versions of study NCT00887146 on ClinicalTrials.gov Archive Site

Change Historyclick the link provided for a complete list of historical versions of study NCT00887146 on ClinicalTrials.gov Archive Site.

  • Time to progression [ Time Frame: Time from study registration to the earliest evidence of clinical progression, radiographic progression or neurocognitive progression, assessed up to 16 years ] [ Designated as safety issue:  ]Estimated by Kaplan-Meier method and analyzed by Cox regression model adjusting all stratification factors. Correlations among baseline neurocognitive test scores and progression free survival will be analyzed using Cox proportional hazards model.

  • Time to neurocognitive progression, assessed using the Hopkins Verbal Learning Test-Revised for Free Recall, Delayed Recall, and Delayed Recognition; the Controlled Oral Word Association test; and the Trail Making Test Part A or B [ Time Frame: Time from study registration to the first cognitive failure, assessed up to 16 years ] [ Designated as safety issue:  ]Estimated by Kaplan-Meier method and analyzed by Cox regression model adjusting all stratification factors. For each test in the battery, a standard error of measurement will be used to derive the Reliable Change Index (RCI) which will be used to represent the 90% confidence interval for the difference in raw scores from baseline to follow-up assessment will be coded as 1 (deterioration), 2 (no change), and 3 (improved) according to the RCI.

  • Overall survival [ Time Frame: Time from study registration to time of death due to any cause, assessed up to 16 years ] [ Designated as safety issue:  ]The Cox proportional hazards model will be used to assess whether the distributions of overall survival times differ with respect to treatment regimen having adjusted for all stratification factors (cooperative groups, age, and Performance Score). The distribution of overall survival for Arm A and B will be estimated using the Kaplan-Meier method. The hazard ratios and median survivals will be estimated with their 95% confidence intervals.

  • Objective tumor response defined as a complete response or partial response [ Time Frame: Up to 16 years ] [ Designated as safety issue:  ]Summarized for each arm and compared between the arms using the Chi square test.

  • Treatment-related adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 16 years ] [ Designated as safety issue:  ]The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. In addition, will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. Adverse events and treatment-related adverse events will be evaluated using all patients. Treatment-related adverse events will be tabulated for each arm.

Current Secondary Outcome Measures Secondary measurements that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Specify Title, Time Frame, Description (if needed) and Safety Issue as described above.

Same as current.

Original Secondary Outcome MeasuresSecondary measurements that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Specify Title, Time Frame, Description (if needed) and Safety Issue as described above.

Current Other Outcome MeasuresAny other measurements, excluding post-hoc measures, that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Specify Title, Time Frame, Description (if needed) and Safety Issue.

Not Provided

Original Other Outcome MeasuresAny other measurements, excluding post-hoc measures, that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Specify Title, Time Frame, Description (if needed) and Safety Issue.

Descriptive Information

Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

Brief TitleProtocol title intended for the lay public.

Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

Official TitlesOfficial name of the protocol provided by the study principal investigator or sponsor.

Radiation therapy uses high-energy x-rays to kill tumor cells. 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. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

Brief SummaryShort description of the protocol intended for the lay public. Include a brief statement of the study hypothesis.

This study will be a randomized phase III for patients with newly diagnosed co-deleted 1p/19q anaplastic glioma or high risk low grade glioma. The trial will only enroll patients with 1p/19q co-deletion. This study includes two arms as described in the "Arms" section. A dynamic allocation procedure will be used to allocate an equal number of patients to different arms (Arms A:B = 1:1). This procedure will balance the marginal distributions of the stratification factors among arms. The stratification factors that will be used are cooperative groups (EORTC vs. all North American groups), age (≤ 50 vs. > 50), performance score (ECOG 0-1 vs. 2), and tumor grade (anaplastic glioma vs. low grade glioma). The primary goal is to determine whether patients who receive radiotherapy with concomitant temozolomide (TMZ) followed by adjuvant temozolomide (RT + TMZ --> TMZ) (Arm B) have a marginally better progression free survival (PFS) as compared with patients who receive radiotherapy followed by PCV chemotherapy (RT --> PCV)(Arm A). Secondary Goals: 1. Time to Progression - To determine whether patients who receive (RT + TMZ --> TMZ) have a significantly longer time to progression (clinical or radiographic progression) as compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy (RT --> PCV). 2. Correlation between exploratory biomarkers and survival - To determine whether there is a difference in survival based on t(1;19)(q10, p10) translocation status and MGMT promoter hypermethylation status. 3. Descriptive Comparisons of Additional Secondary Endpoints - To perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumor response, prognostic factor analysis and quality of life. 4. Toxicity - To determine the toxicity of the treatment in each arm and perform descriptive comparisons. 5. Neurocognitive and Quality of Life (QOL) Effects - To determine the neurocognitive and QOL effects in patients treated on this protocol and correlate these results with outcome endpoints. 6. Banking of Biospecimens and Neuroimaging Studies - To store blood products (i.e., plasma, DNA and buffy coat), tumor tissue and MRI/CT images for future scientific investigations. After completion of study treatment, patients are followed every 12 weeks for 1 year, then every 4 months for 2 years and then every 6 months until progressive disease or until the end of study participation.

Detailed DescriptionExtended description of the protocol, including more technical information.

Interventional

Study TypeInterventional study in human beings in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed.

Observational study in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

Expanded Access records describing the procedure for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled clinical study. Expanded Access records are used to register all types of non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track.

Study DesignTOOLTIP TOO ELABORATE

Target Follow-Up DurationFor Patient Registries, the anticipated time period over which each participant is to be followed. Provide a number and select a unit of time (years, months, weeks, days).

False

BiospecimenuSpecify all types of biospecimens to be retained (e.g., whole blood, serum, white cells, urine, tissue).

Brain and Central Nervous System Tumors

ConditionPrimary disease or condition being studied, or focus of the study. Diseases or conditions should use the National Library of Medicine's Medical Subject Headings (MeSH) controlled vocabulary when possible.

Drug: concomitant temozolomide (TMZ)

75 mg/m^2, orally daily

Radiation: radiotherapy

Drug: procarbazine

Days 8-21: 60 mg/m^2 orally

Drug: adjuvant temozolomide (TMZ)

150 or 200 mg/m^2 orally

Drug: CCNU

Day 1: 110 mg/m^2 orally

Drug: vincristine

Days 8 and 29: 1.4 mg/m^2 IV

InterventionFor all studies, and for expanded access records, specify the associated intervention(s). For interventional studies, at least one intervention must be specified. For observational studies, specify the intervention(s)/exposure(s) of interest, if any.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

This study is currently recruiting participants.

Recruiting StatusTOOLTIP TOO COMPLEX TO DISPLAY

360

Estimated EnrollmentNumber of subjects in the trial.

Completion DateFinal date on which data was (or is expected to be) collected.

December 2018

Estimated Primary Completion DateThe date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated.

Pre-Registration Inclusion Criteria: - United States (US) and Canadian sites: * This review is mandatory prior to registration to confirm eligibility; patients must be willing to submit tissue samples for mandatory central pathology review submission; it should be initiated as soon after surgery as possible - Tissue must have been determined to have local 1p/9q co-deletion and IDH mutation prior to submission for central path review - Tumor tissue must show co-deletion of chromosomes 1p and 19q; for eligibility, the 1p/19q analysis results will be accepted from the local site, as determined by either a locally available or reference laboratory (for US, must be Clinical Laboratory Improvement Act [CLIA] certified); acceptable methods for determination of 1p/19q loss include fluorescent in-situ hybridization (FISH), by genomic sequencing or methylomic analyses; US and Canadian sites must send a copy of the official report to the pathology coordinator and quality assurance specialist (QAS) - Tumor must also show evidence of IDH mutation by immunohistochemistry or genomic analyses; this should be performed at the local site (US: performed in a CLIA certified laboratory); the site must send a copy of the official report to the pathology coordinator and QAS Registration Inclusion Criteria: - Newly diagnosed and =< 3 months from surgical diagnosis; patients are also eligible if they have had a prior surgical procedure > 3 months earlier for low grade glioma, as long as the patient has not received prior radiation or prior chemotherapy - Histological evidence of World Health Organization (WHO) grade III anaplastic glioma or WHO grade II low grade glioma with locally diagnosed combined 1p/19q loss and the presence of an either IDH1 or IDH2, both as established by a local or referenced laboratory qualified for the study * Note: mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q - Patients with codeleted low grade gliomas must also be considered "high risk" by exhibiting one or more of the following characteristics: - Age >= 40 and any surgical therapy - Age < 40 with prior and subtotal resection or biopsy (i.e., anything less than gross total resection) - Documented growth following prior surgery (NOTE: patients with prior surgery cannot have received prior radiation, chemotherapy or targeted therapy) - Intractable seizures - Surgery (partial or gross total resection or biopsy) must be performed >= 2 weeks prior to registration; patient must have recovered adequately from the effects of surgery - Absolute neutrophil count (ANC) >= 1,500/mm^3 obtained =< 21 days prior to registration - Platelet (PLTs) count >= 100,000/mm^3 obtained =< 21 days prior to registration - Hemoglobin (Hgb) > 9.0 g/dL obtained =< 21 days prior to registration - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) obtained =< 21 days prior to registration - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN obtained =< 21 days prior to registration - Creatinine =< 1.5 x ULN obtained =< 21 days prior to registration - Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only - Willingness and ability to personally complete neurocognitive testing (without assistance) and willingness to complete the QOL testing, (either personally or with assistance) - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2 - Written informed consent - Willingness to return to enrolling institution for follow-up during the active monitoring phase (that is, the active treatment and observation portion) of the study); patients who have been formally transferred to another active and approved site participating in this study would not need to return to the enrolling institution for this purpose - Willingness to allow the provision of tissue samples for correlative research, as long as adequate tissues are available; patients will not be excluded from participation in the study, if they are willing to allow provision of tissues for the correlative research, but there are insufficient quantities of tissue for the correlative analyses (e.g., a patient otherwise eligible and willing who had biopsy only) Willingness to allow the provision of blood samples for correlative research; patients are not excluded from participation in the study, if they are willing to provide the mandatory biospecimens for translational/correlative research, but for logistical reasons the specimens(s) were not obtainable or if the volume collected was insufficient Registration Exclusion Criteria: - The following categories are ineligible: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception or contraceptive method during this study and 6 months following the completion of chemotherapy treatments - History of prior radiation therapy or chemotherapy for glioma; note: patients who have a history of prior low grade glioma (with or without a distant history of prior surgery for that glioma), but who have never received prior chemotherapy or radiation therapy for the glioma are eligible for the study - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens - Concomitant serious immunocompromised status (other than that related to concomitant steroids) that would compromise the safety of the patient on the study - Patients known to be human immunodeficiency virus (HIV) positive and currently receiving retroviral therapy are not eligible; note: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for the study - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Receiving any other investigational agent that would be considered as a treatment for the primary neoplasm - Other active malignancy within 5 years of registration; exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix; note: if there is a history of prior malignancy, the patient is not eligible if they are receiving other specific treatment (with the exclusion of hormonal therapy or Her-2 inhibitors) for their cancer or if they have received prior total body irradiation which included the brain - History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias - Recent history of hepatitis infection or if the treating physician determined that the patient would be at significant risk of reactivation of hepatitis

Eligibility CriteriaPhysical gender of individuals who may participate in the protocol.

Minimum and/or maximum age of participants.

Indicate if persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study.

All

GenderBoth: both female and male participants are being studied

Female: only female participants are being studied

Male: only male participants are being studied

Minimum Age: 18 Years

AgesMinimum Age
Definition: Minimum age of participants. Provide a number and select a unit of time (years, months, weeks, days, hours or minutes). Select "N/A (No limit)" if no minimum age is indicated.

Maximum Age
Definition: Maximum age of participants. Provide a number and a unit of time (years, months, weeks, days, hours or minutes). Select "N/A (No limit)" if no maximum age is indicated.

No

Accepts Healthy VolunteersAccepts Healthy Volunteers

Paul D. Brown

904-202-7319

Cathy.Gonzales@bmcjax.com

Cathy Gonzales, RN, BSN, OCN, CCRP

ContactsCentral Contact - Person providing centralized, coordinated recruitment information for the entire study.
Central Contact Backup - Person to contact if Central Contact is not available.
Overall Study Officials - Person(s) responsible for the overall scientific leadership of the protocol, including study principal investigator.

Austria, Belgium, Canada, France, Netherlands, Switzerland, United States

Listed Location CountriesDESCRIPTION

,

Removed CountriesDESCRIPTION

Recruitment Information

NCT00887146

NCT NumberA unique identification code is given to each clinical study registered on ClinicalTrials.gov. Because the format is the letters "NCT" followed by an 8-digit number (for example, NCT00000419), this identifier is also known as the NCT Number.

N0577

Other Study ID NumbersUnique identification assigned to the protocol by the sponsoring organization, usually an accession number or a variation of a grant number. Multiple studies conducted under the same grant must each have a unique number.

No

Has Data Monitoring CommitteeGGGGGGG

Alliance for Clinical Trials in Oncology

Responsible PartySponsor: the entity (e.g., corporation or agency) that initiates the study
Principal Investigator: the individual who serves as the principal investigator and is designated as responsible party, consistent with the conditions described in the statute Sponsor-Investigator: the individual who both initiates and conducts the study

National Cancer Institute (NCI), European Organisation for Research and Treatment Center (EORTC), NCIC Clinical Trials Group

CollaboratorA collaborator is an organization other than the sponsor that provides support for a clinical study. This may include funding, design, implementation, data analysis, or reporting.

StudyChair: Kurt Jaeckle, MD | Mayo Clinic

InvestigatorsThe person who both initiates and conducts the clinical study.

Alliance for Clinical Trials in Oncology

Information Provided ByThe contents of the study record are provided by this organization or person. This sponsor, sponsor-investigator, or sponsor-designated principal investigator is responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information.

April 2018

Verification DateDate the protocol information was last verified. Verification date is shown along with organization name on ClinicalTrials.gov to indicate to the public whether the information is being kept current, particularly recruiting status and contact information.

SOURCE: Clinicaltrials.gov

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