NCT01498835

Brief Summary

To evaluate the toxicity of sunitinib concurrently given with irradiation for preoperative treatment of locally advanced or recurrent soft tissue sarcoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2012

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

December 21, 2011

Last Update Submit

August 25, 2017

Conditions

Soft Tissue Sarcoma

Keywords

Soft tissue sarcomaRadiation therapySunitinib

Outcome Measures

Primary Outcomes (1)

  • To evaluate the dose limiting toxicity and maximal tolerated dose of sunitinib given concurrently with irradiation as neoadjuvant treatment in soft tissue sarcoma.

    Toxicity of the study treatment will be documented according to CTCAE 4.0 during and until 4 weeks after study treatment.

    12 weeks

Secondary Outcomes (1)

  • To evaluate the response to sunitinib given concurrently with radiation as neoadjuvant treatment in soft tissue sarcoma.

    6 weeks after completion of study treatment.

Study Arms (1)

Combined Sunitinib and irradiation

EXPERIMENTAL

Patients with locally advanced or recurrent soft tissue sarcoma will receive Sunitinib and irradiation as neoadjuvant treatment. Restaging and tumor resection will be performed 6 weeks after completion of sunitinib and irradiation.

Drug: Sunitinib

Interventions

SunitinibDRUG

Patients will receive Sunitinib daily for 2 weeks prior to and then concurrently with irradiation as neoadjuvant treatment. Radiotherapy will be given as intensity modulated radiation therapy with a total dose of 50.4Gy in 28 fractions to each patient (5 1/2 weeks). Sunitinib will be given in two dose levels. The first dose level will be 25mg Sunitinib per os daily. The second dose level will be 37.5mg sunitinib per os daily. A dose modification schedule according to a 3+3 design will be applied for patient accrual.

Also known as: Radiation therapy
Combined Sunitinib and irradiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically proven soft tissue sarcoma of any histology but GIST, Angiosarcoma, dermatofibrosarcoma protuberans, Ewing Sarcoma or Embryonal Rhabdomyosarcoma
  • patients with primary tumors OR with local recurrences who did not receive prior radiation therapy OR with solitary metastatic lesions may be included
  • complete resection after neoadjuvant treatment is expected
  • age of 18 or older
  • ECOG performance score 0 or 1
  • normal organ and bone marrow function
  • ability to give written informed consent

You may not qualify if:

  • medication with inhibitors or inducers of CYP3A4
  • history of myocardial infarction, stroke or thromboembolic events
  • clinical signs of heart failure (NYHA 3 or 4)
  • anticoagulation with Vitamin K antagonists
  • acquired or hereditary coagulopathy
  • uncontrolled hypertension
  • uncontrolled intercurrent illness
  • women who are pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helios Klinikum Bad Saarow

Bad Saarow, 15526, Germany

Location

University Medical Center Mannheim

Mannheim, 68167, Germany

Location

Related Publications (2)

  • Jakob J, Simeonova A, Kasper B, Ronellenfitsch U, Rauch G, Wenz F, Hohenberger P. Combined sunitinib and radiation therapy for preoperative treatment of soft tissue sarcoma: results of a phase I trial of the German interdisciplinary sarcoma group (GISG-03). Radiat Oncol. 2016 Jun 3;11:77. doi: 10.1186/s13014-016-0654-2.

    PMID: 27255678DERIVED

  • Jakob J, Rauch G, Wenz F, Hohenberger P. Phase I trial of concurrent sunitinib and radiation therapy as preoperative treatment for soft tissue sarcoma. BMJ Open. 2013 Sep 18;3(9):e003626. doi: 10.1136/bmjopen-2013-003626.

    PMID: 24048627DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

SunitinibRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTherapeutics

Study Officials

  • Peter Hohenberger, MD PhD

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 21, 2011

First Posted

December 23, 2011

Study Start

February 1, 2012

Primary Completion

November 1, 2014

Study Completion

February 1, 2015

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

DE(2)