Trial of Neoadjuvant Conformal Radiotherapy Plus Sorafenib for Patients With Soft Tissue Sarcoma of the Extremity and Body Wall - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Soft Tissue Sarcoma
Intervention:	Drug: Sorafenib

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Sorafenib 200/200	Dose level 1 sorafenib 200 bid with concurrent neoadjuvant radiation therapy. sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent.
Sorafenib 200/400	Dose level 2 sorafenib 200 mg PO Q AM and 400 mg PO Q PM with concurrent neoadjuvant radiation therapy. sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent. Traditional 3+3 dose escalation Phase I trial. Cohort 2 enrolled after completion of all 3 participants in dose level 1.
Sorafenib 400/400	Dose level 3 sorafenib 400 mg PO BID with concurrent neoadjuvant radiation therapy. sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent.

Description

Sorafenib 200/200

Dose level 1 sorafenib 200 bid with concurrent neoadjuvant radiation therapy.

sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent.

Sorafenib 200/400

Dose level 2 sorafenib 200 mg PO Q AM and 400 mg PO Q PM with concurrent neoadjuvant radiation therapy.

sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent.

Traditional 3+3 dose escalation Phase I trial. Cohort 2 enrolled after completion of all 3 participants in dose level 1.

Sorafenib 400/400

Dose level 3 sorafenib 400 mg PO BID with concurrent neoadjuvant radiation therapy.

sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent.

Participant Flow: Overall Study

	Sorafenib 200/200	Sorafenib 200/400
STARTED	3	5
COMPLETED	3	5
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Phase I	No text entered.

Baseline Measures

	Phase I
Number of Participants [units: participants]	8
Age [units: participants]
<=18 years	0
Between 18 and 65 years	7
>=65 years	1
Age [units: years] Mean ± Standard Deviation	44 ± 12
Gender [units: participants]
Female	5
Male	3
Region of Enrollment [units: participants]
United States	8

Outcome Measures

1. Primary:

Number of Dose Limiting Toxicities [ Time Frame: Approximately 12 weeks ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Dr. Robert J. Canter
Organization: University of California Davis Comprehensive Cancer Center
phone: 916-734-5907
e-mail: robert.canter@ucdmc.ucdavis.edu

No publications provided

Responsible Party:	Robert J. Canter, MD, University of California, Davis
ClinicalTrials.gov Identifier:	NCT00864032 History of Changes
Other Study ID Numbers:	STS Sorafenib
Study First Received:	March 17, 2009
Results First Received:	January 15, 2013
Last Updated:	April 9, 2013
Health Authority:	United States: Food and Drug Administration