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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2016
Actual
Sample size
Target
26
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
Trial website
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

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/NCT00753727