Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - 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.

Other interventions: 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
Other interventions
Intervention code [3] 0 0
Treatment: Surgery
Intervention code [4] 0 0
Treatment: Other
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Hampshire
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
South Dakota
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
Belgium
State/province [26] 0 0
Antwerpen
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussels
Country [28] 0 0
Belgium
State/province [28] 0 0
Charleroi
Country [29] 0 0
Belgium
State/province [29] 0 0
Gent
Country [30] 0 0
Belgium
State/province [30] 0 0
Leuven
Country [31] 0 0
Canada
State/province [31] 0 0
Calgary
Country [32] 0 0
Canada
State/province [32] 0 0
London
Country [33] 0 0
Canada
State/province [33] 0 0
Saskatoon
Country [34] 0 0
Canada
State/province [34] 0 0
Toronto
Country [35] 0 0
Canada
State/province [35] 0 0
Winnipeg
Country [36] 0 0
France
State/province [36] 0 0
Marseille
Country [37] 0 0
France
State/province [37] 0 0
Nancy
Country [38] 0 0
France
State/province [38] 0 0
Nice
Country [39] 0 0
France
State/province [39] 0 0
Paris
Country [40] 0 0
France
State/province [40] 0 0
Rennes
Country [41] 0 0
France
State/province [41] 0 0
Villejuif
Country [42] 0 0
Germany
State/province [42] 0 0
Bamberg
Country [43] 0 0
Germany
State/province [43] 0 0
Bonn
Country [44] 0 0
Germany
State/province [44] 0 0
Hannover
Country [45] 0 0
Germany
State/province [45] 0 0
Heidelberg
Country [46] 0 0
Germany
State/province [46] 0 0
Regensburg
Country [47] 0 0
Germany
State/province [47] 0 0
Tuebingen
Country [48] 0 0
Israel
State/province [48] 0 0
Tel Aviv
Country [49] 0 0
Italy
State/province [49] 0 0
Bologna
Country [50] 0 0
Italy
State/province [50] 0 0
Milano
Country [51] 0 0
Italy
State/province [51] 0 0
Torino
Country [52] 0 0
Netherlands
State/province [52] 0 0
Amsterdam
Country [53] 0 0
Netherlands
State/province [53] 0 0
Den Haag
Country [54] 0 0
Netherlands
State/province [54] 0 0
Groningen
Country [55] 0 0
Netherlands
State/province [55] 0 0
Maastricht
Country [56] 0 0
Netherlands
State/province [56] 0 0
Nijmegen
Country [57] 0 0
Netherlands
State/province [57] 0 0
Rotterdam
Country [58] 0 0
Spain
State/province [58] 0 0
Barcelona
Country [59] 0 0
Switzerland
State/province [59] 0 0
Geneve
Country [60] 0 0
Switzerland
State/province [60] 0 0
Zurich
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Bristol
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Cambridge
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Cheltenham
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Edinburgh
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Exeter
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Leeds
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Manchester
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Nottingham
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Plymouth
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Sheffield
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Sutton
Country [72] 0 0
United Kingdom
State/province [72] 0 0
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
Other
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00626990
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00626990