Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma

NCT00753727

Last updated date
Study Location
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3002, Australia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Soft Tissue Sarcoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Soft Tissue SarcomaSunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma
NCT00753727
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Advanced Information
Descriptive Information
Brief Title  ICMJE Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma
Official Title  ICMJE A Phase IB/II Study of Sunitinib in Combination With Neoadjuvant Radiation in Patients With Resectable Soft-tissue Sarcoma
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.
Detailed Description

The presence of hypoxia has been documented in soft-tissue sarcomas, where it may contribute to radioresistance. Combinations of radiosensitisers such as ifosfamide and doxorubicin with radiotherapy have demonstrated promise in sarcomas, but with significant toxicity.

The rationale for this study is based on:

  • the frequency of hypoxia in soft-tissue sarcomas
  • the importance of radiotherapy in neoadjuvant treatment of soft-tissue sarcomas
  • targeting hypoxic vasculature with sunitinib
  • the single agent activity of sunitinib in soft-tissue sarcomas. This study will assess the feasibility and tolerability of the combination of sunitinib with standard preoperative radiotherapy. The surrogate endpoints of tumor necrosis and functional and RECIST imaging response will provide early evidence of response rate. Toxicities will be assessed both during chemoradiation and following surgery. The impact of treatment on the hypoxic component of the tumor will be investigated with F18 azamycin arabinoside PET scans.

Because the combination of sunitinib and radiotherapy has not been studied before, we propose a phase Ib design with dose reductions in the event of excessive toxicity. Sunitinib treatment will precede the commencement of radiotherapy by 2 weeks because there is preclinical evidence that priming the tumor vasculature may increase synergy with radiotherapy, and because sunitinib may have single agent activity in sarcomas, including measurable effects on tumor vasculature. Because it is anticipated that the likelihood of complications attributable to the combination of sunitinib and radiotherapy will be small, the starting dose of sunitinib will be 50mg/day for the two week lead-in period and then 25mg for 5 weeks with concurrent radiotherapy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Soft Tissue Sarcoma
Intervention  ICMJE
  • Drug: 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.
    Other Name: Sutent
  • Radiation: 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 15, 2008)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2016
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00753727
Other Study ID Numbers  ICMJE ASSG01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Associate Professor David Thomas, Peter MacCallum Cancer Centre
Study Sponsor  ICMJE Australasian Sarcoma Study Group
Collaborators  ICMJE
  • Peter MacCallum Cancer Centre, Australia
  • Pfizer
Investigators  ICMJE
Principal Investigator:David Thomas, MB BS PhDPeter MacCallum Cancer Centre, Australia
PRS Account Australasian Sarcoma Study Group
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP