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| ID | Type | Description | Link |
|---|---|---|---|
| CSET 2022/3510 | Other Identifier | Gustave Roussy ID |
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The goal of this clinical trial is to assess the efficacy of thromboprophylaxis in preventing venous thromboembolic events (VTE) in good and intermediate prognosis patients with metastatic germ cell cancer (GCT) undergoing first-line cisplatin-based chemotherapy with risk factors for developing a thromboembolic event .
The high-risk patients will be randomized between two treatments arm (receiving a thromboprophylaxis in the experimental arm, or no thromboprophylaxis in the control arm). The low-risk patients will be observed without any thromboprophylaxis. Patients will participate in the study for 14-17 weeks depending on the planned number of cycles of chemotherapy.
Researchers will compare an experimental arm with thromboprophylaxis and a control arm without thromboprophylaxis to detect an absolute decrease of 12% of the proportion of patients having experienced a VTE, from 21% (high risk patients, control arm) to 9% (high risk patients, experimental arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental for high-risk patients | Experimental | Thromboprophylaxis in addition of the standard chemotherapy |
|
| Control for high-risk patients | No Intervention | No thromboprophylaxis in addition of the standard chemotherapy | |
| Low-risk patients | No Intervention | No thromboprophylaxis in addition of the standard chemotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thromboprophylaxis | Drug | Thromboprophylaxis in addition of the standard chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients undergoing a thromboembolic event | (composite end point: symptomatic or asymptomatic (incidental finding) venous thrombosis or pulmonary embolism or unexplained death) | from randomization up to 6 weeks after D1 of the last cycle of chemotherapy or up to the residual masses surgery, whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ophélie LION | Contact | +33 (0)1 42 11 48 41 | ophelie.lion@gustaveroussy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Karim FIZAZI, MD | Gustave Roussy, Cancer Campus, Grand Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICO Paul Papin | Recruiting | Angers | 49100 | France |
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| CH de la Côte Basque | Recruiting | Bayonne | 64100 | France |
|
| Institut Bergonié | Not yet recruiting | Bordeaux | 33000 | France |
|
| CHU de Brest | Not yet recruiting | Brest | 29200 | France |
|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
|
| Groupe Hospitalier Mutualiste de Grenoble | Not yet recruiting | Grenoble | 38000 | France |
|
| Centre Oscar Lambret | Recruiting | Lille | 59000 | France |
|
| CHU de Limoges | Recruiting | Limoges | 87000 | France |
|
| Centre Léon Bérard | Recruiting | Lyon | 69000 | France |
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| Institut Paoli-Calmettes | Not yet recruiting | Marseille | 13273 | France |
|
| Centre Antoine Lacassagne | Recruiting | Nice | 06189 | France |
|
| Hôpital Saint Louis | Recruiting | Paris | 75010 | France |
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| Hôpital Tenon | Not yet recruiting | Paris | 75020 | France |
|
| CHU de Poitiers | Recruiting | Poitiers | 86000 | France |
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| Clinique La Croix du Sud | Recruiting | Quint-Fonsegrives | 31130 | France |
|
| Institut Godinot | Not yet recruiting | Reims | 51726 | France |
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| Centre Eugène Marquis | Recruiting | Rennes | 35000 | France |
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| CHU de St Etienne | Recruiting | Saint-Etienne | 42270 | France |
|
| Institut de Cancérologie de l'Ouest | Recruiting | Saint-Herblain | 44805 | France |
|
| HIA Bégin | Recruiting | Saint-Mandé | 94160 | France |
|
| ICANS | Recruiting | Strasbourg | 67200 | France |
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| Hôpital Foch | Not yet recruiting | Suresnes | 92150 | France |
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| Oncopole Claudius Regaud | Not yet recruiting | Toulouse | 31059 | France |
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| CHU Bretonneau | Recruiting | Tours | 37044 | France |
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| Institut de Cancérologie de Lorraine | Recruiting | Vandœuvre-lès-Nancy | 54500 | France |
|
| Gustave Roussy | Recruiting | Villejuif | 94800 | France |
|
| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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