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Studien am Sarkomzentrum Mannheim

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GISG-19/HECTOR

Predictive value of liquid biopsy (cfDNA) in high-risk GIST patients

SSG XXII

Three versus five years of adjuvant Imatinib as treatment of patients with operable GIST with a high risk for recurrence: A randomised phase III multicenter study by the Scandinavian Sarcoma Group.

EORTC 1809 (STRASS 2)

A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)

NIR-DT-301/DeFi

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients With Progressing Desmoid Tumors /Aggressive Fibromatosis (DT)(AF)

TRacKING

Real world European registry of NTRK fusions and other rare actionable fusions

RAIN-3201/MANTRA

A Randomized Multicenter Phase 3 Study of Milademetan versus Trabectedin in Patients with dedifferentiated Liposarcoma

BRIGHTLINE

Phase II/III BI 907828 + BI 754091 in 1st L DD Liposarcoma

GISG-18/GISAR & Subprojekt MORNING

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

Studien on-hold

z.Zt. keine Studien on hold

Studien geplant

EORTC 1553 (SPECTA)

A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)

AL-DES-01/RINGSIDE

A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients with Progressing Desmoid Tumors

INHBRX-109

A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma

PEAK

A PHASE 3 RANDOMIZED, OPEN-LABEL, MULTICENTER CLINICAL STUDY OF CGT9486+SUNITINIB VS SUNITINIB IN SUBJECTS WITH LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC GASTROINTESTINAL STROMAL TUMORS

Studien beendet

AMN107 (Novartis)

Eine randomisierte, offene, multizentrische Phase III-Studie zur Untersuchung der Wirksamkeit und Sicherheit von Nilotinib gegenüber Imatinib bei erwachsenen Patienten mit nicht operablen oder metastasierten gastrointestinalen Stroma-Tumoren (GIST.

EORTC 62072 (Palette)

A randomized double blind phase III trial of Pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy.

GISG-01 (Desmoid)

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.

PAPAGEMO

Phase II randomized clinical trial of Pazopanib alone and Pazopanib plus Gemcitabine in relapsed or metastatic soft tissue sarcoma.

GISG-02 (GemYon)

Phase I dose escalating trial evaluating the combination of Gemcitabine and Trabectedin (Yondelis) in patients with advanced and/or metastatic Leiomyosarcoma or Liposarcom.

GISG-03 (SUNRASE)

Phase I Studie der neoadjuvanten Therapie von Weichgewebssarkomen mit Sunitinib und perkutaner Bestrahlung.

CF-DNA GIST

Prospective, explorative trial for the detection of circulating cellfree tumor DNA in the plasma of patients with gastrointestinal stromal tumors (GIST) harboring activating mutations of CKIT or PDGFRA pre/post-surgery or pre/under treatment with a tyrosine kinase inhibitor or progressive disease irrespective of current or planned treatment.

GISG-04 (NOPASS)

A phase II window-of-opportunity study of preoperative therapy with Pazopanib (Votrient) in high-risk soft tissue sarcoma.

GISG-05 (EPAZ)

A randomized phase II trial comparing pazopanib with doxorubicin as first line treatment in elderly patients with metastatic or advanced soft tissue sarcoma.

SSG XXI

Pazopanib in advanced gastrointestinal stromal tumors refractory to Imatinib and Sunitinib.

GISG-07

Phase II Clinical Trial of Pazopanib 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.

EORTC 62092 (STRASS)

A phase III randomized study of preoperative radiotherapy plus surgery versus surgery alone for patients with retroperitoneal sarcoma (RPS).

GISG-08 (Image)

A non-interventional multicenter, prospective study to evaluate treatment outcome as assessed in routine clinical practice on patients with advanced soft tissue sarcoma treated with trabectedin according to the Summary of Product Characteristics (SmPC).

Threshold

A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma.

BRF117019

A Phase II, Open-label, Study in Subjects with BRAF V600EMutated Rare Cancers with Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib.

GISG-12 (YONLIFE)

Patient directed intervention towards a multidimensional recommendation guideline to improve the quality of life for patients with soft tissue sarcoma under palliative treatment with trabectedin – YONLIFE.

NBTXR3

A multicenter randomized, open-label phase II/III study, to compare the efficacy of NBTXR3, implanted as intratumor injection and ctivated by radiotherapy, versus radiotherapy alone in patients with locally advanced soft tissue sarcoma of the extremity and trunk wal.

Announce

A randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in Patients with advanced of Metastatic Soft Tissue Sarcoma.

EORTC 90101 (CREATE)

Cross-tumoral phase 2 clinical trial exploring crizotinib (PF-02341066) in patients with advanced tumors induced by causal alterations of ALK and/or MET (“CREATE”).

BAY 73-4506/14874 (Bayer)

A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib.

E7389-G000-209 (EISAI)

A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin with Dacarbazine in Subjects with Soft Tissue Sarcoma.

IMCL CP13-0707 (ImClone)

A Five-Tier, Phase 2 Open-Label Study of IMC-A12 Administered as a Single Agent Every 2 Weeks in Patients With Previously-Treated, Advanced or Metastatic Soft Tissue and Ewing's Sarcoma/PNET

Infinity IPI-926-04

Doppelblinde, placebokontrollierte klinische Prüfung der Phase II zur Evaluierung der Sicherheit und der Wirksamkeit der Anwendung von IPI 926 bei Patienten mit metastasiertem oder lokal fortgeschrittenem (nicht resektablem) Chondrosarkom.

EORTC 62091 (TRUSTS)

A phase IIb/III multicenter study comparing the efficacy of Trabectedin administered as a 3-hour or 24 hour infusion to doxorubicin in patients with advanced or metastatic untreated soft tissue sarcoma.

GISG-06 (EVA)

EVA (evaluation of votrient in angiosarcoma): Einarmige, multizentrische offene Phase-II-Studie zur Überprüfung der Wirksamkeit der Kombination von Paclitaxel mit Pazopanib bei fortgeschrittenen und rezidivierten Angio­sarkomen

AB Science 11002

A prospective, multicenter, randomised, open-label, activecontrolled, two-parallel groups, phase 3 study to compare the efficacy and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor after progression with imatinib.

GISG-14 (RetraSarc)

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

BLU

An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

GIST-M3

Unifying Advanced Treatment with Advanced Imaging

MINDED

Vergleich der Wirksamkeit einer humanen azellulären Dermis (Epiflex®) gegen ein chirurgisches Standardtherapieverfahren im Verschluss des offenen Abdomens in Bezug auf die Vermeidung der ventralen Hernienentwicklung

EWING 2008

Randomisierte klinische Studie zur Therapieoptimierung bei Patienten mit lokalisiertem oder metastasiertem Ewing-Sarkom

GISG-11/PazoQoL (NIS)

Lebensqualität von Patienten mit Weichteilsarkom unter palliativer Chemotherapie oder Pazopanib – eine randomisierte kontrollierte Studie

SEAL

PHASE 2-3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF SELINEXOR (KPT-330) VERSUS PLACEBO IN PATIENTS WITH ADVANCED UNRESECTABLE DEDIFFERENTIATED LIPOSARCOMA (DDLS)

MediSarc

A randomized phase II study of Durvalumab (MEDI4736) and Tremelimumab compared to doxorubicin in patients with advanced or metastatic soft tissue sarcoma

NIR-DT-301

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients with Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

GISG-15/NitraSarc

Combined treatment with Nivolumab and Trabectedin in patients with metastatic or inoperable soft tissue Sarcomas - The NiTraSarc Phase II TrialPOnatinib after rEsisTance to Imatinib in GIST

ARO-012

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Trial of Crenolanib in Subjects with Advanced or Metastatic Gastrointestinal Stromal Tumors with a D842V Mutation in the PDGFRA Gene.

POETIG

Phase 2 trial of ponatinib in patients with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) following failure or intolerance of prior therapy with imatinib (POETIG trial – POnatinib after rEsisTance to Imatinib in GIST)

GISG-13 (E-TRAB)

Geriatric assessment of elderly ‘unsuited’ patients receiving Trabectedin in first line treatment for advanced soft tissue sarcomas (STS) – E-TRAB.

PROSa

Krankheitslast und Versorgungssituation bei Sarkomen: Eine nationale Studie zu Einflussfaktoren patientenberichteter Krankheitsfolgen bei Menschen mit Sarkomerkrankungen.

EORTC 1317/STBSG

Phase II study of cabozantinib in patients with metastatic gastrointestinal stromal tumor (GIST) who progressed during neoadjuvant, adjuvant or palliative therapy with imatinib and sunitinib

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