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Trial registered on ANZCTR


Registration number
ACTRN12608000474358
Ethics application status
Approved
Date submitted
9/09/2008
Date registered
23/09/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase IB/II study of sunitinib in combination with neoadjuvant radiation in patients with resectable soft tissue sarcoma
Scientific title
Phase 1B/II dose escalation study to assess the feasibility and tolerability of the combination of sunitinib with standard pre-operative radiotherapy for soft tissue sarcoma
Secondary ID [1] 712 0
ASSG01
Universal Trial Number (UTN)
Trial acronym
SUNXRT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft tissue sarcoma 3659 0
Condition category
Condition code
Cancer 3826 3826 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Seven and a half weeks treatment: 14 days of oral administered sunitinib followed by 5 weeks of combination treatment comprising standard pre-operative radiotherapy and oral administered sunitinib. During the lead-in phase all patients will receive 50mg of Sunitinib (4 tablets of 12.5 mg) per day. During combination treatment patients will receive either 25mg (dose level 0), 37.5mg (dose level 1) or 12.5mg (dose level -1) per day (a maximum of 3 tablets per day). The first 6 patients will receive dose level 0. The dose for each subsequent patient cohort will be determined by the number of dose limiting toxicities (DLTs) observed during treatment.

If less than 2 DLTs are observed in the first 6 patients on dose level 0, the next 6 patients will be escalated to dose level 1. If there are less than 2 DLTs in the first 6 patients on dose level 1, dose level 1 will be considered the maximum tolerated dose (MTD) and all subsequent patients will receive dose level 1. If there are 2 or more DLTs in the first 6 patients at dose level 1, the dose for all subsequent patients will be reduced to dose level 0, which will be considered the MTD.

If there are 2 DLTs in the first 6 patients on dose level 0, a further 6 patients will be treated at this dose level. If there are 2 DLTs in the second 6 patients at dose level 0, the dose will be increased to dose level 1 for the next 6 patients, and will follow the same rules from dose level 1 (as stated above) to find the MTD. If there are 3 DLTs in the second 6 patients (therefore 5 DLTs in 12 patients on this dose), dose level 0 will be considered the MTD and all subsequent patients will receive dose level 0. If there are more than 3 DLTs in the second 6 patients, the dose for the next 6 patients will be reduced to dose level -1 and the rules from dose level -1 (stated below) will be followed.

If there are more than 2 DLTs in the first 6 patients on dose level 0, the next 6 patients will be reduced to dose level -1. If less than 2 of the first 6 patients on dose level -1 have DLTs, dose level -1 will be considered the MTD and all subsequent patients will receive dose level -1. If 2 or more patients have DLTs on dose level -1, the trial will be terminated.

External beam radiotherapy is given at a dose of 50.4Gy in 28 fractions (5 days per week) for all patients regardless of Sunitinib dose level.
Intervention code [1] 3375 0
Treatment: Drugs
Intervention code [2] 3376 0
Treatment: Other
Comparator / control treatment
Phase II study (no comparator)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4727 0
To determine the maximum dose of sunitinib at which the combination of sunitinib and radiotherapy pre-operatively is safe and tolerable. Patients will be closely monitored for adverse events during the course of treatment. Dose limiting toxicities have been defined based on Common Terminology Criteria for Adverse Events (CTCAE) and will be reported immediately if observed. If two or more dose-limiting toxicites are observed in patients the Sunitinib dose during radiotherapy may be modified for subsequent patients.
Timepoint [1] 4727 0
Baseline; post-2 weeks sunitinib only administration; post-sunitinib and radiotherapy combination treatment; 12 weeks post-surgery
Secondary outcome [1] 7980 0
To estimate response rates for the combination of sunitinib and radiotherapy. Response rates will be measured by each of the following three metrics: i) Response Evaluation Criteria in Solid Tumors (RECIST); ii) functional imaging with 18F-Deoxyglucose Positron emission tomography (FDG-PET); and iii) histologic (i.e. pathologic) response.
Timepoint [1] 7980 0
Baseline; post-2 weeks sunitinib only administration; post-sunitinib and radiotherapy combination treatment; and at surgery

Eligibility
Key inclusion criteria
Histologically confirmed soft-tissue sarcoma suitable for neoadjuvant radiotherapy and surgery; minimum age 16 years; Eastern Cooperative Oncology Group (ECOG) performance status =1 or less; life expectancy of greater than 6 months; patients must have normal organ and marrow function; no evidence of a bleeding or thrombotic tendency, and no evidence of arterial or venous thrombosis; not pregnant or breastfeeding; and the ability to give written informed consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Soft-tissue sarcoma located in sites where radiotherapy is associated with significant exposure of abdominal viscera; patients with other invasive malignancies, with the exception of non-melanoma skin cancer, in the last 5 years; patients receiving any other therapeutic investigational agents; patients who are receiving concurrent treatment with any other anti-cancer therapy; evidence of distant metastases; uncontrolled intercurrent illness; patients who are pregnant or breast feeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 3915 0
Commercial sector/Industry
Name [1] 3915 0
Pfizer Inc.
Country [1] 3915 0
United States of America
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Locked Bag 1, A'Beckett Street, Melbourne, Victoria, 8006
Country
Australia
Secondary sponsor category [1] 3453 0
None
Name [1] 3453 0
Address [1] 3453 0
Country [1] 3453 0
Other collaborator category [1] 429 0
Other Collaborative groups
Name [1] 429 0
Australasian Sarcoma Study Group Limited
Address [1] 429 0
Peter MacCallum Cancer Centre Locked Bag 1 A'Beckett Street Melbourne Victoria 8006
Country [1] 429 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5978 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 5978 0
Ethics committee country [1] 5978 0
Australia
Date submitted for ethics approval [1] 5978 0
Approval date [1] 5978 0
28/04/2008
Ethics approval number [1] 5978 0
08/05

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

Contacts
Principal investigator
Name 28913 0
Address 28913 0
Country 28913 0
Phone 28913 0
Fax 28913 0
Email 28913 0
Contact person for public queries
Name 12070 0
Dr Sally Whyte
Address 12070 0
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street, Melbourne, Victoria, 8006
Country 12070 0
Australia
Phone 12070 0
+61396563605
Fax 12070 0
+61396561411
Email 12070 0
sally.whyte@petermac.org
Contact person for scientific queries
Name 2998 0
Associate Professor David Thomas
Address 2998 0
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street, Melbourne, Victoria, 8006
Country 2998 0
Australia
Phone 2998 0
+61396561111
Fax 2998 0
+61396561411
Email 2998 0
sally.whyte@petermac.org

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.