Informations générales (source: ClinicalTrials.gov)
Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
Interventional
Phase 3
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
octobre 2023
février 2028
15 septembre 2025
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Karim FIZAZI | 18/03/2024 10:17:25 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Tenon | Mathieu JAMELOT, MD | Contact (sur clinicalTrials) | |||
| HOPITAL FOCH | Christine ABRAHAM, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Agnès DUCOULOMBIER, MD | Contact (sur clinicalTrials) | |||
| Centre Eugène Marquis - 35000 - Rennes - France | Bettina BOUTRUCHE, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69000 - Lyon - France | Aude FLECHON, MD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59000 - Lille - France | Guillaume CARBONNELLE, MD | Contact (sur clinicalTrials) | |||
| CH de la Côte Basque - 64100 - Bayonne - France | Louis FRANCOIS, MD | Contact (sur clinicalTrials) | |||
| CHU Bretonneau - 37044 - Tours - France | Mathilde CANCEL, MD | Contact (sur clinicalTrials) | |||
| CHU de Brest - 29200 - Brest - France | Benjamin AUBERGER, MD | Contact (sur clinicalTrials) | |||
| CHU de Clermont-Ferrand - 63000 - Clermont-Ferrand - France | Sébastien BAILLY, MD | Contact (sur clinicalTrials) | |||
| CHU de Limoges - 87000 - Limoges - France | Tiffany DARBAS, MD | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - 86000 - Poitiers - France | Sheik EMAMBUX, MD | Contact (sur clinicalTrials) | |||
| CHU de St Etienne - 42270 - Saint-Étienne - France | Pierre CORNILLON, MD | Contact (sur clinicalTrials) | |||
| Clinique La Croix du Sud - 31130 - Quint-Fonsegrives - France | Francesco RICCI, MD | Contact (sur clinicalTrials) | |||
| Groupe Hospitalier Mutualiste de Grenoble - 38000 - Grenoble - France | Eve FAUGERAS, MD | Contact (sur clinicalTrials) | |||
| HIA Bégin - 94160 - Saint-Mandé - France | Carole HELISSEY, MD | Contact (sur clinicalTrials) | |||
| Hôpital Saint Louis - 75010 - Paris - France | Clément DUMONT, MD | Contact (sur clinicalTrials) | |||
| ICANS - 67200 - Strasbourg - France | Laure PIERARD, MD | Contact (sur clinicalTrials) | |||
| ICO Paul Papin - 49100 - Angers - France | Elouen BOUGHALEM, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonié - 33000 - Bordeaux - France | Guilhem ROUBAUD, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de Lorraine - 54500 - Vandoeuvre les nancy - France | Camille SIMON, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - 44805 - Saint-Herblain - France | Emmanuelle BOMPAS, MD | Contact (sur clinicalTrials) | |||
| Institut Godinot - 51726 - Reims - France | Camille MAZZA, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13273 - Marseille - France | Mathilde GUERIN, MD | Contact (sur clinicalTrials) | |||
| Oncopole Claudius Regaud - 31059 - Toulouse - France | Loïc MOUREY, MD | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion Criteria:
- Diagnosis of good or intermediate prognosis of Germ Cell Tumor (according to the
International Germ Cell Cancer Collaborative Group)
- Older than 18 years
- Suitable for first-line cisplatin-based chemotherapy
- No prior systemic cytotoxic therapy
- Additional criteria for patients who will be randomized (Venous Thromboembolic Event
(VTE) high-risk patients): Lactate dehydrogenase higher than 1 Upper Normal Level
and/or Body Surface Area higher than 1.9 and/or longer than 5 cm long axis
retroperitoneal lymph nodes
- Patient should understand, sign, and date the written informed consent form prior to
any protocol-specific procedures performed. Patient should be able and willing to
comply with study visits and procedures as per protocol.
- Patients must be affiliated to a social security system or beneficiary of the same
- Diagnosis of good or intermediate prognosis of Germ Cell Tumor (according to the
International Germ Cell Cancer Collaborative Group)
- Older than 18 years
- Suitable for first-line cisplatin-based chemotherapy
- No prior systemic cytotoxic therapy
- Additional criteria for patients who will be randomized (Venous Thromboembolic Event
(VTE) high-risk patients): Lactate dehydrogenase higher than 1 Upper Normal Level
and/or Body Surface Area higher than 1.9 and/or longer than 5 cm long axis
retroperitoneal lymph nodes
- Patient should understand, sign, and date the written informed consent form prior to
any protocol-specific procedures performed. Patient should be able and willing to
comply with study visits and procedures as per protocol.
- Patients must be affiliated to a social security system or beneficiary of the same
- Brain metastasis
- History of VTE
- Concomitant use of anticoagulants or antiaggregants
- Renal impairment defined as creatinine clearance less than 50 ml/min using
Cockcroft-Gault formula
- Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other
low molecular weight heparins (LMWH) or to any of the excipients
- Any major surgery (i.e. open surgery lasting more than 45 minutes from opening to
closure) within 4 weeks or planned during the study treatment period
- Severe uncontrolled high blood pressure (systolic blood pressure > 180 mmHg or
diastolic blood pressure > 110 mmHg)
- Low baseline platelet count (< 100 X 10^9 /L) or history of heparin-induced
thrombocytopenia
- Active clinically significant bleeding and conditions with a high risk of
haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence
of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic
surgery, known or suspected oesophageal varices, arteriovenous malformations,
vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
- Extensive metastatic disease at high risk of bleeding, e.g. prevalent
choriocarcinoma
- Participation in another clinical study with an investigational product during the
last 4 weeks, and while on study treatment without the approval from sponsor
- Patient under guardianship or deprived of his liberty by a judicial or
administrative decision or incapable of giving its consent