Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00777153
Registration number
NCT00777153
Ethics application status
Date submitted
20/10/2008
Date registered
22/10/2008
Date last updated
28/12/2016
Titles & IDs
Public title
Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma
Query!
Scientific title
A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy of Lomustine Alone
Query!
Secondary ID [1]
0
0
D8480C00055
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
REGAL
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Recurrent Glioblastoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Brain
Query!
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Cediranib
Treatment: Drugs - Cediranib
Treatment: Drugs - Lomustine Chemotherapy
Treatment: Drugs - Placebo Cediranib
Experimental: Cediranib 30mg - Cediranib 30mg
Other: Cediranib 20mg + lomustine - Cediranib 20mg + lomustine
Active comparator: Lomustine and Placebo Cediranib - Lomustine and Placebo Cediranib
Treatment: Drugs: Cediranib
30 mg/day, oral, until progression
Treatment: Drugs: Cediranib
20 mg/day, oral, until progression
Treatment: Drugs: Lomustine Chemotherapy
110 mg/m2 / Q6W, oral, until progression
Treatment: Drugs: Placebo Cediranib
Oral, until progression
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression Free Survival (PFS)
Query!
Assessment method [1]
0
0
For patients with measurable disease at entry (at least one lesion that has a shortest diameter
=10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that:
1. The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is =15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days.
2. The patient has died from any cause.
3. A new lesion is detected that is outside the original tumor volume and has a shortest diameter =10 mm.
Query!
Timepoint [1]
0
0
Baseline at 6 weeks and then every 6 weeks to discontinuation
Query!
Secondary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
Number of months from randomisation to the date of death from any cause
Query!
Timepoint [1]
0
0
Baseline through to date of death up to 25th April 2010
Query!
Secondary outcome [2]
0
0
Response Rate
Query!
Assessment method [2]
0
0
An individual visit response of PR was defined as a greater than or equal to 50% reduction in the sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions compared to baseline as long as the steroid dose has not been increased within the previous 10 days and no new lesions are present.
An individual visit response of CR was defined as the complete disappearance of all tumor on MRI scan.
Query!
Timepoint [2]
0
0
Baseline at 6 weeks and then every 6 weeks to discontinuation
Query!
Secondary outcome [3]
0
0
Alive and Progression Free Rate at 6 Months (APF6)
Query!
Assessment method [3]
0
0
Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques. Values are percentages.
Query!
Timepoint [3]
0
0
6 Months
Query!
Secondary outcome [4]
0
0
Daily Steroid Dose
Query!
Assessment method [4]
0
0
The mean steroid dosage prior to treatment will be considered as the patient's baseline. The percent change in average daily steroid dosage from baseline is calculated by following formula: PC = (md - bm)/bm\*100; where PC is the percent change in average daily steroid dosage from baseline; md the mean daily steroid dosage recorded from the first day of therapy to progression; and bm the baseline mean.
Query!
Timepoint [4]
0
0
Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25
Query!
Secondary outcome [5]
0
0
Steroid Free Days
Query!
Assessment method [5]
0
0
Number of days known not to have used any steroids prior to progression
Query!
Timepoint [5]
0
0
Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25
Query!
Eligibility
Key inclusion criteria
* Confirmation of recurrent glioblastoma
* Life expectancy = 12 weeks
* Received only one prior systemic chemotherapy regimen and this regimen must contain temozolomide
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
100
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Patients on enzyme-inducing anti-epileptic drugs within 3 weeks prior to randomisation
* Poorly controlled hypertension
* Previous anti-angiogenesis (eg bevacizumab, sorafenib, sunitinib) therapy
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/10/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/09/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
423
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Camperdown
Query!
Recruitment hospital [2]
0
0
Research Site - Heidelberg
Query!
Recruitment hospital [3]
0
0
Research Site - Nedlands
Query!
Recruitment hospital [4]
0
0
Research Site - Parkville
Query!
Recruitment hospital [5]
0
0
Research Site - St Leonards
Query!
Recruitment hospital [6]
0
0
Research Site - Woodville
Query!
Recruitment postcode(s) [1]
0
0
- Camperdown
Query!
Recruitment postcode(s) [2]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [3]
0
0
- Nedlands
Query!
Recruitment postcode(s) [4]
0
0
- Parkville
Query!
Recruitment postcode(s) [5]
0
0
- St Leonards
Query!
Recruitment postcode(s) [6]
0
0
- Woodville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Washington
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
West Virginia
Query!
Country [16]
0
0
Austria
Query!
State/province [16]
0
0
Graz
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Brussels (Anderlecht)
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Brussels (Jette)
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Brussels (Woluwé-St-Lambert)
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Leuven
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Alberta
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Ontario
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Quebec
Query!
Country [24]
0
0
Czech Republic
Query!
State/province [24]
0
0
Liberec
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Bobigny
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Marseille
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Paris cedex 13
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Rennes
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Saint Herblain
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Villejuif
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Berlin
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Bielefeld
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Dresden
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Düsseldorf
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Göttingen
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Hannover
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Heidelberg
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Kiel
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Leipzig
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Nordhausen
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Regensburg
Query!
Country [42]
0
0
Netherlands
Query!
State/province [42]
0
0
Amsterdam
Query!
Country [43]
0
0
Netherlands
Query!
State/province [43]
0
0
Den Haag
Query!
Country [44]
0
0
Netherlands
Query!
State/province [44]
0
0
Groningen
Query!
Country [45]
0
0
Netherlands
Query!
State/province [45]
0
0
Maastricht
Query!
Country [46]
0
0
Netherlands
Query!
State/province [46]
0
0
Rotterdam
Query!
Country [47]
0
0
United Kingdom
Query!
State/province [47]
0
0
Glasgow
Query!
Country [48]
0
0
United Kingdom
Query!
State/province [48]
0
0
London
Query!
Country [49]
0
0
United Kingdom
Query!
State/province [49]
0
0
Manchester
Query!
Country [50]
0
0
United Kingdom
Query!
State/province [50]
0
0
Sutton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to see how effective cediranib is in treating a brain tumour called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents. Cediranib is a new drug that has not yet been approved for this disease. This study will compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo ("inactive substance") to see whether the combination or cediranib alone will be more effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00777153
Query!
Trial related presentations / publications
Batchelor TT, Mulholland P, Neyns B, Nabors LB, Campone M, Wick A, Mason W, Mikkelsen T, Phuphanich S, Ashby LS, Degroot J, Gattamaneni R, Cher L, Rosenthal M, Payer F, Jurgensmeier JM, Jain RK, Sorensen AG, Xu J, Liu Q, van den Bent M. Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma. J Clin Oncol. 2013 Sep 10;31(26):3212-8. doi: 10.1200/JCO.2012.47.2464. Epub 2013 Aug 12.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Jane Robertson
Query!
Address
0
0
AstraZeneca
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00777153
Download to PDF