Trial record 1 of 1 for:    RTOG-0834
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Radiation Therapy With or Without Temozolomide in Treating Patients With Anaplastic Glioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2011 by National Cancer Institute (NCI)
Sponsor:
Collaborators:
NCIC Clinical Trials Group
Radiation Therapy Oncology Group
Medical Research Council
Cooperative Trials Group for Neuro-Oncology
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00626990
First received: February 28, 2008
Last updated: September 16, 2011
Last verified: May 2011
  Purpose

RATIONALE: 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. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.

PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy alone in treating patients with anaplastic glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: temozolomide
Genetic: DNA methylation analysis
Other: laboratory biomarker analysis
Procedure: adjuvant therapy
Procedure: quality-of-life assessment
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival as measured from the day of randomization [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Neurological deterioration-free survival [ Designated as safety issue: No ]
  • Quality of life as assessed by the EORTC Quality of Life Questionnaire (QLQ-C30) version 3 and the Brain Cancer Module-20 [ Designated as safety issue: No ]
  • Toxicity as measured by CTEP Active Version of CTCAE [ Designated as safety issue: Yes ]
  • Development of cognitive deterioration as measured by the Mini Mental Status Exam [ Designated as safety issue: Yes ]

Estimated Enrollment: 1360
Study Start Date: December 2007
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To assess whether concurrent radiotherapy with daily temozolomide improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma.
  • To assess whether adjuvant temozolomide improves survival as compared to no adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma.

Secondary

  • To assess whether concurrent and adjuvant temozolomide prolongs progression-free survival and neurological deterioration-free survival in patients with non-1p/19q deleted anaplastic glioma.
  • To assess the safety of concurrent and adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma, including late effects on cognition.
  • To assess the impact of concurrent and adjuvant temozolomide on the quality of life of patients with non-1p/19q deleted anaplastic glioma.

OUTLINE: This is a multicenter study. Patients are stratified according to institution, WHO performance status (0 vs > 0), age (≤ 50 vs > 50), presence of 1p LOH only (yes vs no), presence of oligodendroglial elements (yes vs no), and O6-methylguanine-DNA methyltransferase promoter methylation status (methylated vs unmethylated vs indeterminate). Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients undergo radiotherapy* once daily, 5 days a week, for 6.5 weeks (total of 33 fractions).
  • Arm II: Patients undergo radiotherapy* once daily, 5 days a week and receive oral temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy).
  • Arm III: Patients undergo radiotherapy* once daily, 5 days a week for 6.5 weeks (total of 33 fractions). Beginning 4 weeks after completion of radiotherapy, patients receive adjuvant oral temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for up to 12 courses.
  • Arm IV: Patients undergo radiotherapy* once daily, 5 days a week and receive oral temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy). Beginning 4 weeks after completion of radiotherapy, patients receive adjuvant oral temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for up to 12 courses.

NOTE: *Patients must begin radiotherapy within 8 days after randomization and within 7 weeks after surgery.

In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life questionnaires, including QLQ-C30 version 3, BCM20, and the Mini Mental Status Exam at baseline, 4 weeks after the completion of radiotherapy, and then every 3 months for 5 years.

Tissue samples are collected at baseline for histology review, 1p/19q analysis, methylation status of the O6-methylguanine-DNA methyltransferase promoter, and isocitrate dehydrogenase mutation analysis.

After completion of study treatment, patients are followed every 3 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following:

    • Anaplastic oligodendroglioma
    • Anaplastic oligoastrocytoma
    • Anaplastic astrocytoma
  • Newly diagnosed disease
  • Prior surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
  • Absence of combined 1p/19q loss
  • Tumor material available for central 1p/19q assessment, central O6-methylguanine-DNA methyltransferase promoter methylation status assessment, isocitrate dehydrogenase mutation analysis, and central pathology review
  • Patients must be on a stable or decreasing dose of steroids for at least two weeks prior to randomization

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • ANC ≥ 1.5 x 10^9 cells/L
  • Platelet count ≥ 100 x 10^9 cells/L
  • Bilirubin < 1.5 x upper limit of normal (ULN)
  • Alkaline phosphatase < 2.5 x ULN
  • AST and ALT < 2.5 x ULN
  • Serum creatinine < 1.5 x ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No known HIV infection or chronic hepatitis B or hepatitis C infection
  • No other serious medical condition that would interfere with follow-up
  • No medical condition that could interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction)
  • No other prior malignancies except for any malignancy which was treated with curative intent more than 5 years prior to registration and adequately controlled limited basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
  • No prior or concurrent malignancies at other sites except for surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No psychological, familial, sociological, or geographical condition that would potentially hamper compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy, including carmustine-containing wafers (Gliadel®)
  • No prior radiotherapy to the brain
  • No concurrent growth factors unless vital for the patient
  • No other concurrent investigational treatment
  • No other concurrent anticancer agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626990

Locations
Australia, Western Australia
Sir Charles Gairdner Hospital - Nedlands Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Anna Nowak, MD    61-8-9346-3841      
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: David Eisenstat    204-787-1169      
Germany
Universitatsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Contact Person    49-6221-566-703      
Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center Recruiting
Rotterdam, Netherlands, 3008 AE
Contact: Contact Person    31-10-704-1415      
United Kingdom
Bristol Haematology and Oncology Centre Recruiting
Bristol, England, United Kingdom, BS2 8ED
Contact: Contact Person    44-117-928-3074      
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 0QQ
Contact: Contact Person    44-1223-245-151      
Gloucestershire Oncology Centre at Cheltenham General Hospital Recruiting
Cheltenham, England, United Kingdom, GL53 7AN
Contact: Contact Person    44-8454-222-222      
Royal Devon and Exeter Hospital Recruiting
Exeter, England, United Kingdom, EX2 5DW
Contact: Contact Person    44-1392-411-611      
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Contact Person    44-113-206-6400      
Christie Hospital Recruiting
Manchester, England, United Kingdom, M20 4BX
Contact: Contact Person    44-845-226-3000      
Nottingham City Hospital Recruiting
Nottingham, England, United Kingdom, NG5 1PB
Contact: Contact Person    44-115-969-1169      
Derriford Hospital Recruiting
Plymouth, England, United Kingdom, PL6 8DH
Contact: Contact Person    44-175-277-7111      
Cancer Research Centre at Weston Park Hospital Recruiting
Sheffield, England, United Kingdom, S10 2SJ
Contact: Contact Person    44-114-226-5000      
Edinburgh Cancer Centre at Western General Hospital Recruiting
Edinburgh, Scotland, United Kingdom, EH4 2XU
Contact: Contact Person    44-131-537-1000      
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
Radiation Therapy Oncology Group
Medical Research Council
Cooperative Trials Group for Neuro-Oncology
Investigators
Study Chair: Wolfgang Wick Universitatsklinikum Heidelberg
Study Chair: Warren P. Mason, MD Princess Margaret Hospital, Canada
Study Chair: Michael A. Vogelbaum, MD, PhD The Cleveland Clinic
Study Chair: S. Erridge Medical Research Council
Study Chair: Anna Nowak, MD Sir Charles Gairdner Hospital - Nedlands
  More Information

Additional Information:
No publications provided

Responsible Party: Regulatory Affairs Associate, European Organization for Research and Treatment of Cancer
ClinicalTrials.gov Identifier: NCT00626990     History of Changes
Other Study ID Numbers: CDR0000582632, EORTC-26053, CAN-NCIC-CEC1, RTOG-0834, EORTC-22054, EUDRACT-2006-001533-17, SPRI-EORTC-26053, MERCK-EORTC-26053, MRC-BR14, COGNO-EORTC-26053
Study First Received: February 28, 2008
Last Updated: September 16, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult anaplastic oligodendroglioma
adult anaplastic astrocytoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014