NCT01543802

Brief Summary

The purpose of this study is to examine if a short-term treatment with pazopanib, an oral drug inhibiting the growth of blood vessel, can reduce the metabolism of soft-tissue sarcomas and thus facilitate their resection when given prior to surgery. Moreover, the study assesses the prognostic and predictive value of several new biomarkers (endothelial progenitor cells, soluble vascular epithelial growth factor),

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2013

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
terminated

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

February 10, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

January 26, 2021

Status Verified

December 1, 2015

Enrollment Period

3.5 years

First QC Date

February 10, 2012

Last Update Submit

January 22, 2021

Conditions

Sarcoma, Soft-tissue

Keywords

soft-tissue sarcomapazopanibantiangiogenetic treatmentendothelial progenitor cellspreoperative therapy

Outcome Measures

Primary Outcomes (1)

  • Metabolic response rate

    Metabolic response rate is defined as the proportion of patients achieving a metabolic response, i.e. a 50% reduction of the mean standardized uptake value (SUVmean) in the post-treatment compared to the pre-treatment FDG-PET-CT

    day 22-28 (time of post-treatment PET-CT)

Secondary Outcomes (11)

  • Percentage of tumor tissue with regressive alterations upon resection ("Histopathological Response")

    day 28-35

  • Decrease in tumor size in MRI according to RECIST 1.1 criteria

    baseline and day 22-28

  • Change of FDG influx as well as of transport rates k1-k4 and distribution volume VB and fractal dimension in dynamic PET-CT ("Dynamic PET-CT Response")

    baseline and day 22-28

  • Number of days for which planned resection is delayed after treatment

    day 28-35

  • Number of patients in which adverse events occur during treatment

    day 1-21

  • +6 more secondary outcomes

Study Arms (1)

Pazopanib

EXPERIMENTAL
Drug: pazopanib

Interventions

pazopanibDRUG

Treatment with pazopanib 800 mg qd for 21 days followed by resection of the tumor after a 7-14 days break

Also known as: Votrient
Pazopanib

Eligibility Criteria

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

You may qualify if:

  • Written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
  • Age ≥ 18 years or legal age of consent if different from 18 years.
  • Non-metastatic primary tumor or locoregional recurrence of histologically confirmed high-risk (G2/3, diameter ≥5 cm) soft tissue sarcoma (STS) of any location (extremities, girdle, trunk, retroperitoneum); or metachronous solitary metastasis of STS for which surgical resection is planned according to the individual choice of the multidisciplinary treatment team (no grade or size restrictions apply for metastasis).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Measurable disease according to RECIST 1.1
  • Resectable and solitary tumor, as assessed by the investigator based on staging exams (CT scan of the chest, CT or MRI of the abdomen, MRI of the limb in case of extremity STS).
  • Adequate organ system function
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of study treatment and agree to use effective contraception, during the study and until after surgery has been performed.
  • Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.

You may not qualify if:

  • The following tumor types are ineligible
  • Embryonal rhabdomyosarcoma
  • Chondrosarcoma
  • Osteosarcoma
  • Ewing tumors / PNET
  • Gastro-intestinal stromal tumors
  • Dermofibromatosis sarcoma protuberans
  • Inflammatory myofibroblastic sarcoma
  • Malignant mesothelioma
  • Prior malignancy.
  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.
  • Prior or concurrent systemic chemotherapy or molecularly targeted therapy for STS or other malignancies within five years before study entry.
  • Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
  • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
  • Corrected QT interval (QTc) \> 480 msecs (calculation according to Bazett).
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Klinikum Frankfurt-Höchst

Frankfurt am Main, 65929, Germany

Location

German Cancer Research Center, Medical PET Group - Biological Imaging

Heidelberg, 69120, Germany

Location

University Hospital Heidelberg / National Centre for Tumor Diseases

Heidelberg, 69120, Germany

Location

University Hospital Mannheim, Dpt. of Surgery

Mannheim, 68135, Germany

Location

Related Publications (2)

  • Ronellenfitsch U, Karampinis I, Dimitrakopoulou-Strauss A, Sachpekidis C, Jakob J, Kasper B, Nowak K, Pilz L, Attenberger U, Gaiser T, Derigs HG, Schwarzbach M, Hohenberger P. Preoperative Pazopanib in High-Risk Soft Tissue Sarcoma: Phase II Window-of Opportunity Study of the German Interdisciplinary Sarcoma Group (NOPASS/GISG-04). Ann Surg Oncol. 2019 May;26(5):1332-1339. doi: 10.1245/s10434-019-07183-4. Epub 2019 Mar 6.

    PMID: 30843160DERIVED

  • Ronellenfitsch U, Dimitrakopoulou-Strauss A, Jakob J, Kasper B, Nowak K, Pilz LR, Attenberger U, Gaiser T, Egerer G, Frohling S, Derigs HG, Schwarzbach M, Hohenberger P. Preoperative therapy with pazopanib in high-risk soft tissue sarcoma: a phase II window-of-opportunity study by the German Interdisciplinary Sarcoma Group (GISG-04/NOPASS). BMJ Open. 2016 Jan 6;6(1):e009558. doi: 10.1136/bmjopen-2015-009558.

    PMID: 26739732DERIVED

Related Links

MeSH Terms

Conditions

Sarcoma

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Peter Hohenberger, MD

    University Hospital Mannheim, Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Division of Surgical Oncology and Thoracic Surgery

Study Record Dates

First Submitted

February 10, 2012

First Posted

March 5, 2012

Study Start

April 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

January 26, 2021

Record last verified: 2015-12

Locations

DE(4)