Studien der GISG



Phase II study to evaluate Glivec (imatinib mesylate) to induce progression arrest in aggressive Fibromatosis / desmoid tumors not amenable to surgical resection with R0 intent or accompanied by unacceptable function loss. (B. Kasper/P. Hohenberger - Mannheim)

EudraCT Number: 2007-000624-40

Trial Status: closed (September 2013) - LPLV: Oct 2015
Date of activation: July 2010
Patients enrolled: 39

Phase I study dose escalating trial evaluating the combination of Gemcitabine and Trabectedin (Yondelis®) in patients with advanced and/or metastatic leiomyosarcoma or liposarcoma. (B. Kasper - Mannheim)

EudraCT Number: 2010-022117-26

Trial Status: closed (May 2014) - LPLV: Aug 2014
Date of activation: November 2011
Patients enrolled: 5

Phase I study neoadjuvant radiotherapy and Sunitinib in retroperitoneal soft-tissue sarcomas.
(P. Hohenberger/J. Jakob, Mannheim)

EudraCT Number: 2007-002864-87

Trial Status: closed (May 2014) - LPLV: Jul 2014
Date of activation: January 2012
Patients enrolled: 9

GISG-04 - NOPASS (3 centers)

Phase II Window of opportunity study of neoadjuvant Pazopanib in high-risk soft-tissue sarcomas. (P. Hohenberger / U.Ronellenfitsch - Mannheim)

EudraCT Number: 2011-003745-18

Trial Status: closed 17.10.2016
Date of activation: April 2013
Enrolment status: 18 of 34 patients

GISG-05 - EPAZ (14 centers)

MHH Hannover and HCTC associated randomized phase II trial comparing pazopanib with doxorubicin as first line treatment in elderly patients with metastatic or advanced soft tissue sarcoma (V. Grünwald/HCTC - Hannover)

EudraCT Number: 2011-004168-30

Trial Status: closed
Date of activation: November 2012
Enrolment status: 104 of 120 patients

GISG-06 - EVA (9 centers)

Pazopanib in angiosarcoma patients Phase II (P. Hohenberger - Mannheim/D. Pink - Berlin)

EudraCT Number: 2012-005846-39

Trial Status: closed
Date of activation: Austria= Jun 2014 / Germany= Aug 2014

GISG-07 - GEIS (15 centers)

Spanish Research in Sarcoma Group (GEIS) associated phase II study to evaluate the activity and tolerability in patients with advanced and/or metastatic liposarcoma who have relapsed following standard therapies or for whom no standard therapy exists (Sarcoma Group Spain - LKP Deutschland: B. Kasper-Mannheim)

EudraCT Number: 2012-002745-38

Trial Status: closed
Date of activation: Q4/2013
Patients enrolled: 54 of 74 patients

Non-interventional, multicenter, prospective study to evaluate the methodology of trabectedin treatment outcome in advanced soft tissue sarcoma (STS) patients according to SmPC (PharmaMar - Nationaler Koordinator für Deutschland: B. Kasper-Mannheim)

Short Title: Y-Image
Trial Status: closed (July 2014)

Date of activation: November 2012
Patients enrolled: 218

GISG-09 - NEOPAMAIN (2 centers)

A multicentre randomised double blind phase II study of continuous pazopanib as maintenance therapy in retroperitoneal soft tissue sarcoma following first line treatment with doxorubicin/ifosfamide chemotherapy combined with regional hyperthermia (L. Lindner-München)

Trial Status: pending BfArM approval

Date of activation: Q4/2014
Patients enrolled: closed

GISG-10 - HyperTET

Trabectedin combined with Regional Hyperthermia (RHT) as second line treatment for adult patients with advanced soft-tissue sarcoma (L. Lindner-München)

Trial Status: recruiting

Date of activation: tbd
Patients enrolled: 19 of 120 patients

GISG-11 - PazoQol

Lebensqualität von Patienten mit Weichteilsarkom unter palliativer Chemotherapie oder Pazopanib – eine randomisierte kontrollierte Studie (M. Schuler-Dresden)

Trial Status: closed

Date of activation: tbd
Patients enrolled:

GISG-12 - YonLife

Individualisierte Intervention zur Verbesserung der Lebensqualität bei Patienten mit Weichgewebssarkom in palliativer Therapie mit Trabectedin (M. Schuler-Dresden)

Trial Status: recruiting until end of 2016

Date of activation: tbd
Patients enrolled: 75 patients


Geriatric assessment of elderly "unsuited" patients receiving Trabectedin in first line treatment for advanced soft tissue sarcomas (STS)

Trial Status: recruiting until Q1/2019

Date of activation: 01/2017
Patients enrolled: 57 of 110 patients

GISG-14 - ReTraSarc

Retrospective study to evaluate efficacy and safety of Trabectedin (Yondelis®) in Sarcoma patients

Trial Status: recruiting finished

Date of activation: July 2017

GISG-15 - NitraSarc

Combined treatment with Nivolumab and Trabectedin in patients with metastatic or inoperable soft tissue Sarcoma, a Phase II trail.

Trial status: closed

Date of activation: 2018

GISG-16 - TopArt

Trabectedin + Olaparib in solid tumors harboring DNA repair deficiencies

Trial Status: recruiting

GISG-17 - DexraReDo

Doxorubicin Rechallenge


GISAR - German Interdisciplinary Sarcoma Registry, MORNING: Molecular analyses of advanced or metastatic sarcoma patients via comprehensive genomic profiling (CGP) – A molecular GISAR sub-project

Trial Status: recruting