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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00626990




Registration number
NCT00626990
Ethics application status
Date submitted
28/02/2008
Date registered
29/02/2008
Date last updated
11/09/2023

Titles & IDs
Public title
Phase III Trial of Anaplastic Glioma Without 1p/19q Loss of Heterozygosity (LOH)
Scientific title
Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.
Secondary ID [1] 0 0
NCIC CTG CEC.1
Secondary ID [2] 0 0
EORTC-26053-22054
Universal Trial Number (UTN)
Trial acronym
CATNON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - temozolomide
Treatment: Other - DNA methylation analysis
Other interventions - laboratory biomarker analysis
Treatment: Surgery - adjuvant therapy
Treatment: Surgery - quality-of-life assessment
Treatment: Other - radiation therapy

Active comparator: Radiotherapy (RT) alone - radiation therapy alone

Active comparator: RT & Concurrent CT - Radiotherapy and concurrent temozolomide chemotherapy

Active comparator: RT + Adjuvant CT - Radiotherapy plus adjuvant temozolomide chemotherapy

Active comparator: RT & Concurrent CT + adjuvant CT - Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy


Treatment: Drugs: temozolomide
Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.

Treatment: Other: DNA methylation analysis
O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status is used for stratification at randomization.

Other interventions: laboratory biomarker analysis
Prognostic factor analyses

Treatment: Surgery: adjuvant therapy
Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.

Treatment: Surgery: quality-of-life assessment
Quality of Life analysis will also be used to assess neurological deterioration free progression

Treatment: Other: radiation therapy
Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Intervention code [3] 0 0
Other interventions
Intervention code [4] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival as Measured From the Day of Randomization
Timepoint [1] 0 0
from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study)
Secondary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
from randomization till the date of disease progression or death (time till death is up to 10.9 years after patient enrollment in the study)
Secondary outcome [2] 0 0
Quality of Life of the Patient
Timepoint [2] 0 0
from 14 days prior to randomization till five years or death (time till death is up to 10.9 years after patient enrollment in the study)
Secondary outcome [3] 0 0
Neurological Deterioration Free Survival
Timepoint [3] 0 0
within 2 weeks of randomization; during radiotherapy at week 4 and 6; 4 weeks after the end of radiotherapy; Six monthly after the end of radiotherapy; Prior to each cycle of adjuvant therapy; Every six months after the documentation of first progression.

Eligibility
Key inclusion 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
* Absolute Neutrophil Count (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
* Aspartate Aminotransferase (AST) and Alanine Aminotransferase (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
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2029
Actual
Sample size
Target
Accrual to date
Final
751
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
Austin-Repatriation Medical Centre - Heidelberg
Recruitment hospital [7] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [8] 0 0
St Vincent'S Hospital - Melbourne
Recruitment hospital [9] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [10] 0 0
Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
- Bedford Park
Recruitment postcode(s) [6] 0 0
- Heidelberg
Recruitment postcode(s) [7] 0 0
- Hobart
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment postcode(s) [9] 0 0
- Nedlands
Recruitment postcode(s) [10] 0 0
- Prahran
Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Illinois
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Indiana
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Iowa
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Kansas
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Maine
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Massachusetts
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Michigan
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Nebraska
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New Hampshire
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New York
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North Carolina
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Ohio
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Pennsylvania
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Texas
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Antwerpen
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Charleroi
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Gent
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Bamberg
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Bonn
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Regensburg
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Germany
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Tuebingen
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Israel
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Tel Aviv
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Italy
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Bologna
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Milano
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Torino
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Groningen
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Maastricht
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Nijmegen
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Spain
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Barcelona
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Geneve
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Cambridge
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Cheltenham
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Edinburgh
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Exeter
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Leeds
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Manchester
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Nottingham
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Plymouth
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Sheffield
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Sutton
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United Kingdom
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Wirral

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
NCIC Clinical Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Radiation Therapy Oncology Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Medical Research Council
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/industry
Name [4] 0 0
Merck Sharp & Dohme LLC
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Wolfgang Wick
Address 0 0
Universitatsklinikum Heidelberg
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00626990