Actively Recruiting
Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-06-15
387
Participants Needed
26
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of good or intermediate prognosis germ cell tumor according to the International Germ Cell Cancer Collaborative Group
- Male patients aged 18 years or older
- Suitable for first-line cisplatin-based chemotherapy
- No prior systemic cytotoxic therapy
- For randomization: high-risk for VTE defined by lactate dehydrogenase above 1 Upper Normal Level and/or body surface area greater than 1.9 and/or retroperitoneal lymph nodes longer than 5 cm
- Ability to understand, sign, and date informed consent before any study procedures
- Willingness and ability to comply with study visits and procedures
- Affiliation to a social security system or beneficiary of the same
You will not qualify if you...
- Presence of brain metastasis
- History of venous thromboembolic event
- Current use of anticoagulants or antiaggregants
- Renal impairment with creatinine clearance below 50 ml/min
- Allergy or hypersensitivity to enoxaparin sodium, heparin, low molecular weight heparins, or any excipients
- Major surgery lasting more than 45 minutes within 4 weeks before or planned during study treatment
- Severe uncontrolled high blood pressure (systolic > 180 mmHg or diastolic > 110 mmHg)
- Low baseline platelet count (< 100 x 10^9/L) or history of heparin-induced thrombocytopenia
- Active significant bleeding or conditions with high bleeding risk including recent hemorrhagic stroke, gastrointestinal ulcer, high bleeding risk tumors, recent brain/spinal/eye surgery, esophageal varices, vascular abnormalities
- Extensive metastatic disease with high bleeding risk such as prevalent choriocarcinoma
- Participation in another clinical trial with an investigational product within 4 weeks prior or during study without sponsor approval
- Under guardianship, deprived of liberty by judicial decision, or unable to give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
ICO Paul Papin
Angers, France, 49100
Actively Recruiting
2
CH de la Côte Basque
Bayonne, France, 64100
Actively Recruiting
3
Institut Bergonié
Bordeaux, France, 33000
Not Yet Recruiting
4
CHU de Brest
Brest, France, 29200
Not Yet Recruiting
5
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Actively Recruiting
6
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France, 38000
Not Yet Recruiting
7
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
8
CHU de Limoges
Limoges, France, 87000
Actively Recruiting
9
Centre Léon Bérard
Lyon, France, 69000
Actively Recruiting
10
Institut Paoli-Calmettes
Marseille, France, 13273
Not Yet Recruiting
11
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
12
Hôpital Saint Louis
Paris, France, 75010
Actively Recruiting
13
Hôpital Tenon
Paris, France, 75020
Not Yet Recruiting
14
CHU de Poitiers
Poitiers, France, 86000
Actively Recruiting
15
Clinique La Croix du Sud
Quint-Fonsegrives, France, 31130
Actively Recruiting
16
Institut Godinot
Reims, France, 51726
Not Yet Recruiting
17
Centre Eugène Marquis
Rennes, France, 35000
Actively Recruiting
18
CHU de St Etienne
Saint-Etienne, France, 42270
Actively Recruiting
19
Institut de Cancérologie de l'Ouest
Saint-Herblain, France, 44805
Actively Recruiting
20
HIA Bégin
Saint-Mandé, France, 94160
Actively Recruiting
21
ICANS
Strasbourg, France, 67200
Actively Recruiting
22
Hôpital Foch
Suresnes, France, 92150
Not Yet Recruiting
23
Oncopole Claudius Regaud
Toulouse, France, 31059
Not Yet Recruiting
24
CHU Bretonneau
Tours, France, 37044
Actively Recruiting
25
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
26
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
Research Team
O
Ophélie LION
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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