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Inhalt

Studien am Sarkomzentrum Mannheim

Studien aktiv

YonSar

Nichtinterventionelle Studie zur Wirksamkeit und Sicherheit von Trabectedin (Yondelis®) bei Patienten mit fortgeschrittenem Weichteilsarkom.

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)

EORTC 1317

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.

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.

AROG

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.

GIST M3

Optimized Response Assessment of Gastrointestinal Stromal Tumors Using Dual-Energy CT: Prospective Multicenter-Multinational Trial of Patients Undergoing Targeted Therapy with a TKI Inhibitor.

Minded

Vergleich der Wirksamkeit einer humanen azellulären Dermis (Epiflex®) gegen ein chirurgisches Standardtherapieverfahren im Verschuss des offenen Abdomens in Bezug auf die Vermeidung der ventralen Hernienentwicklung. Eine monozentrische, kontrollierte, prospektive, teilverblindete und randomisierte klinische Phase III Studie.

EORTC 1447

Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients  with advanced or metastatic soft tissue sarcoma.

MEDISARC

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

GISG-14 (RetraSarc)

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

PROSa

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

Studien on-hold

GISG-06 (EVA)

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

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.

Studien geplant

TAPAS

EINE randomisierte Phase-3-Studie über TRC105 und PAZOPANIB im Vergleich zu PAZOPANIB  allein bei Patienten mit fortgeschrittenem ANGIOSARKOM (TAPPAS)

SEAL

A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) versus Placebo in Patients with Advanced Unresectable Dedifferentiated Liposarcoma (DDLS).

BLU-285-1303

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).

INVICTUS

A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients with AdvanCed Gastrointestinal Stromal TUmorS who have Received Treatment with Prior Anticancer Therapie.

EORTC 1553 (SPECTA)

Screening Cancer Patients for Efficient Clinical Trial Acces.

GISG-015 (NiTraSarc)

Combined treatment with Nivolumab and Trabectedin in patients with metastatic or inoperable soft tissue Sarcomas - The NiTraSarc Phase II Tria.

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

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.

Kontextspalte

Leitung

Prof. Dr. med. Peter Hohenberger

Prof. Dr. Peter Hohenberger

E-Mail

Prof. Dr. med. Eric Rössner

Prof. Dr. med. Eric Rössner

E-Mail

Project Management

Dr. sc. hum Marion Bergmann

Dr. sc. hum Marion Bergmann

Studienassistenz

Adalbert Kollak

Adalbert Kollak

Monika Mathew

Monika Mathew