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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00753727




Registration number
NCT00753727
Ethics application status
Date submitted
14/09/2008
Date registered
16/09/2008
Date last updated
23/06/2011

Titles & IDs
Public title
Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma
Scientific title
A Phase IB/II Study of Sunitinib in Combination With Neoadjuvant Radiation in Patients With Resectable Soft-tissue Sarcoma
Secondary ID [1] 0 0
ASSG01
Universal Trial Number (UTN)
Trial acronym
SUNXRT
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sunitinib malate
Treatment: Other - Radiotherapy

Treatment: Drugs: Sunitinib malate
Sunitinib dose 50 mg/day orally for 2 weeks prior to radiotherapy. Treatment Dose Levels during radiotherapy: Dose level 0: Sunitinib 50mg/day for 2 weeks prior to radiotherapy, followed by 25mg/day given concurrently with radiotherapy; Dose level 1: Sunitinib 50mg/day for 2 weeks prior to radiotherapy, followed by 37.5mg/day given concurrently with radiotherapy; Dose level -1: Sunitinib 37.5mg/day for 2 weeks prior to radiotherapy, followed by 37.5mg/day given concurrently with radiotherapy. Dose escalation/de-escalation: first 6 patients will be accrued at dose level 0. The dose levels at which subsequent patients will be accrued will be determined using a dose modification schedule.

Treatment: Other: Radiotherapy
Preoperative radiotherapy consisting of external beam radiotherapy at a dose of 50.4 Gy given in 28 fractions, five days a week, over five weeks and 3 days to the planning target volume.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the maximum dose of sunitinib at which the combination of sunitinib and radiotherapy pre-operatively is safe and tolerable.
Timepoint [1] 0 0
Baseline; post-2 weeks sunitinib only administration; post-sunitinib and radiotherapy combination treatment; 12 weeks post-surgery
Secondary outcome [1] 0 0
To estimate response rates for the combination of sunitinib and radiotherapy.
Timepoint [1] 0 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

- ECOG performance status =1

- 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

- the ability to give written informed consent.
Minimum age
16 Years
Maximum age
No limit
Gender
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)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australasian Sarcoma Study Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Peter MacCallum Cancer Centre, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Pfizer
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This research is being done with the aim of developing a more effective treatment than
standard radiotherapy and surgery alone. Although standard treatment is frequently
successful, some patients do not respond well to this treatment. Low oxygen levels in
tumours, which may be a particular problem with sarcomas, are thought to be one factor that
contributes to failure of radiotherapy. Sunitinib is a new drug that is active against cells
with low oxygen levels. The combination of sunitinib and radiotherapy has shown promising
results in other cancers. The purpose of this study is to find out whether treatment with a
new drug, sunitinib, can increase the effectiveness of radiotherapy at killing cancer cells;
to test the safety of the combination of sunitinib and radiotherapy.
Trial website
https://clinicaltrials.gov/show/NCT00753727
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Thomas, MB BS PhD
Address 0 0
Peter MacCallum Cancer Centre, Australia
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/show/NCT00753727