Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000361505
Ethics application status
Approved
Date submitted
16/08/2006
Date registered
18/08/2006
Date last updated
16/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Multicentre international study of capecitabine +/- bevacizumab as adjuvant treatment of colorectal cancer
Scientific title
Multicentre international study to evaluate the effects of capecitabine +/- bevacizumab on disease free survival as adjuvant treatment of colorectal cancer
Secondary ID [1] 252032 0
EudraCT 2004-000629-32
Secondary ID [2] 252033 0
ISRCTN45133151
Universal Trial Number (UTN)
Trial acronym
QUASAR 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer - Adjuvant Therapy 1330 0
Condition category
Condition code
Cancer 1418 1418 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Capecitabine 1250mg/m2 orally twice daily(total dose 0f 2500mg/m2) from day 1 to day 14, rest for 7 days then repeat every 3 weekly. Plus Bevacizumab 7.5mg/kg intravenous(IV)_ over 30-90 minutes, one dose on day 1, repeated every 3 weekly for 16 cycles.
Intervention code [1] 1304 0
Treatment: Drugs
Comparator / control treatment
Control group: capecitabine 1250mg/m2 twice daily(total dose of 2500mg/m2) from day 1 to day 14, then rest for 7 days and reapeat every 3 weeks for 8 cycles.
Control group
Active

Outcomes
Primary outcome [1] 1939 0
Disease-free survival on all patients (time from randomisation until confirmation of relapse as proven by cytology or radiological evidence of recurrence)
Timepoint [1] 1939 0
3 years
Secondary outcome [1] 3400 0
Disease-free survival on stage III colon cancer patients.
Timepoint [1] 3400 0
Time from randomisation until confirmation of relapse as proven by cytology or radiological evidence of recurrence.

Eligibility
Key inclusion criteria
(1) Histologically proven stage III (stage T2, T3 or T4) and stage II (any one or more of the following – stage T4, lymphatic invasion, vascular invasion, peritoneal involvement, poor differentiation) colorectal cancer (expected ratio 70%:30%). N.B Patients can be Stage II, T3 as long as they have one of the other poor prognostic features. For the purposes of stratification, rectal cancers will be anything below the peritoneal reflection. (2) Patients must have undergone complete resection of the primary tumour without evidence of residual disease. (3) Patients must be randomised to start treatment a minimum of 28 days and maximum of 70 days* after surgery. [If a subject has had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or there is the anticipated need for major surgical procedure during the course of the study they are not eligible]. (4) World Health Organisation (WHO) Performance Status 0 or 1. (5) Male or female outpatients age greater than or equal to 18 years. (6) Written informed consent given. (7) Life expectancy of greater than or equal to 5 years, in terms of non-cancer-related morbidity.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Previous chemotherapy, immunotherapy or infra-diaphragmatic radiotherapy.
(2) Received any investigational drug or agent/procedure, (i.e. participation in another treatment trial) within 4
weeks of randomisation.
(3) Moderate or severe renal impairment [creatinine clearance <30ml/min (calculated according to Cockroft-Gault
formula–see Appendix 4).
(4) Any of the following laboratory values (tests must not have been carried out more than 2 weeks prior to
randomisation):
a. Absolute neutrophil count (ANC) <1.5 x 109/L
b. Platelet count < 100 x 109/L
c. Total bilirubin > 1.5 ULN
d. ALT, AST > 2.5 x ULN
e. Alkaline phosphatase > 2.5 x ULN (ULN = Upper Limit of Normal)
(5) Patients requiring chronic use of full dose oral or parenteral anticoagulants, high dose aspirin (>325mg/day),
anti-platelet drugs or known bleeding diathesis. Low dose aspirin is allowed.
(6) Proteinuria > 500 mg/24 hours.
(7) Known coagulopathy.
(8) Clinically significant cardiovascular disease
[i.e. active; or <12 months since e.g. cerebrovascular accident, myocardial infarction, unstable angina, New
York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia
requiring medication; or uncontrolled hypertension].
(9) Concomitant treatment with sorivudine or its chemically related analogues such as brivudine.
(10) Pregnant (positive pregnancy test within 7 days of starting treatment), or lactating women.
(11) Sexually active patients of child bearing potential not using adequate contraception (male and female).
(12) Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or
squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years.
(13) Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral
medication.
(14) Chronic inflammatory bowel disease and/or bowel obstruction and/or active peptic ulcer.
(15) History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the
investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug
intake.
(16) Patients with known allergy to Chinese hamster ovary cell proteins or other recombinant human or
humanized antibodies or to any excipients of bevacizumab formulation; or to any other study drugs.

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)
Central coordinating center with computer generation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation method will involve the first 50 patients using simple randomisation. The remaining patients being assigned the treatment that would most reduce imbalance with probability 0.8.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
21/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2152
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA,NT,TAS

Funding & Sponsors
Funding source category [1] 1550 0
Commercial sector/Industry
Name [1] 1550 0
Roche Products Australia_Educational Grant
Country [1] 1550 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australiasia Gastro_Intestinal Trial Group (AGITG)
Address
AGITG Coordinating Centre, Lvl 6 Medical Foundation Building, The University of Sydney, 92-94 Parramatta Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 1363 0
Government body
Name [1] 1363 0
NHMRC
Address [1] 1363 0
Address to: NHMRC Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, NSW, 1450
Country [1] 1363 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2980 0
Human Research Ethics Committee of University of Sydney
Ethics committee address [1] 2980 0
Ethics committee country [1] 2980 0
Australia
Date submitted for ethics approval [1] 2980 0
Approval date [1] 2980 0
Ethics approval number [1] 2980 0
06-2006/4/9255

Summary
Brief summary
This study looks at the effects of the drug capecitabine with or without bevacizumab in the treatment of patients with stage III colorectal cancer. You can join this study if you have cancer of the back passage (rectum) or large bowel (colon).
Trial details: Participants will be divided into two groups. One group will receive oral capecitabine (from day 1 to day 14, rest for 7 days then repeat every 3 weekly for a total of 8 cycles), plus intravenous(IV) bevacizumab (one dose on day 1, repeated every 3 weekly for 16 cycles). The other group will receive capecitabine alone (from day 1 to day 14, rest for 7 days then repeat every 3 weekly for a total of 8 cycles), which is standard treatment. New preventative chemotherapies have been developed to reduce the risk of relapse of colorectal cancer. QUASAR2 uses a new combination of an oral chemotherapy drug (capecitabine) and a molecularly targeted therapy (bevacizumab), to determine whether this is more effective and less toxic than capecitabine alone.
Colorectal cancer is the most commonly occurring cancer in Australia (excluding non-melanomic skin cancer), and the second most common cancer-related cause of death, responsible for 4,447 deaths in 2003 (1) As many as 40% of patients who undergo potentially curative treatment will ultimately relapse and die of metastatic disease. This observation has led to the development of adjuvant chemotherapies which reduce the risk of relapse. QUASAR2 uses a new combination for adjuvant therapy: an oral chemotherapy drug (capecitabine) and a molecularly targeted therapy (bevacizumab), to define whether this is superior in efficacy and less in toxicity than capecitabine alone, which is a standard of care in this disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27754 0
Address 27754 0
Country 27754 0
Phone 27754 0
Fax 27754 0
Email 27754 0
Contact person for public queries
Name 10493 0
Kate Roff
Address 10493 0
NHMRC Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, NSW, 1450
Country 10493 0
Australia
Phone 10493 0
61 2 9562 5000
Fax 10493 0
+61 2 9562 5094
Email 10493 0
Quasar2@ctc.usyd.edu.au
Contact person for scientific queries
Name 1421 0
Associate Professor Eva Segelov
Address 1421 0
AGITG Coordinating Centre, Level 6, 88 Mallett Street, Camperdown, NSW 2050
Country 1421 0
Australia
Phone 1421 0
+61 2 9562 5000
Fax 1421 0
+61 2 9562 5094
Email 1421 0
quasar2@ctc.usyd.edu.au

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

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