Trial Title:
Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors
NCT ID:
NCT05874063
Condition:
Germ Cell Tumor
Conditions: Official terms:
Neoplasms, Germ Cell and Embryonal
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Thromboprophylaxis
Description:
Thromboprophylaxis in addition of the standard chemotherapy
Arm group label:
Experimental for high-risk patients
Summary:
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).
Criteria for eligibility:
Criteria:
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
- Signed informed consent
- 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
Exclusion Criteria:
- 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ICO Paul Papin
Address:
City:
Angers
Zip:
49100
Country:
France
Status:
Recruiting
Contact:
Last name:
BOUGHALEM Elouen, MD
Facility:
Name:
CH de la Côte Basque
Address:
City:
Bayonne
Zip:
64100
Country:
France
Status:
Recruiting
Contact:
Last name:
FRANCOIS Louis, MD
Facility:
Name:
CHU de Clermont-Ferrand
Address:
City:
Clermont-Ferrand
Zip:
63000
Country:
France
Status:
Recruiting
Contact:
Last name:
BAILLY Sébastien, MD
Facility:
Name:
Centre Oscar Lambret
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
CARBONNELLE Guillaume, MD
Facility:
Name:
CHU de Limoges
Address:
City:
Limoges
Zip:
87000
Country:
France
Status:
Recruiting
Contact:
Last name:
DARBAS Tiffany, MD
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69000
Country:
France
Status:
Recruiting
Contact:
Last name:
FLECHON Aude, MD
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Zip:
06189
Country:
France
Status:
Recruiting
Contact:
Last name:
DUCOULOMBIER Agnes, MD
Facility:
Name:
CHU de Poitiers
Address:
City:
Poitiers
Zip:
86000
Country:
France
Status:
Recruiting
Contact:
Last name:
EMAMBUX Sheik, MD
Facility:
Name:
Clinique La Croix du Sud
Address:
City:
Quint-Fonsegrives
Zip:
31130
Country:
France
Status:
Recruiting
Contact:
Last name:
RICCI Francesco, MD
Facility:
Name:
Centre Eugène Marquis
Address:
City:
Rennes
Zip:
35000
Country:
France
Status:
Recruiting
Contact:
Last name:
BOUTRUCHE Bettina, MD
Facility:
Name:
HIA Bégin
Address:
City:
Saint-Mandé
Zip:
94160
Country:
France
Status:
Recruiting
Contact:
Last name:
HELISSEY Carole, MD
Facility:
Name:
ICANS
Address:
City:
Strasbourg
Zip:
67200
Country:
France
Status:
Recruiting
Contact:
Last name:
PIERARD Laure, MD
Facility:
Name:
CHU Bretonneau
Address:
City:
Tours
Zip:
37044
Country:
France
Status:
Recruiting
Contact:
Last name:
CANCEL Mathilde, MD
Facility:
Name:
Institut de Cancérologie de Lorraine
Address:
City:
Vandoeuvre les nancy
Zip:
54500
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
SIMON Camille, MD
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Contact:
Last name:
Karim Fizazi, MD
Start date:
October 17, 2023
Completion date:
February 2028
Lead sponsor:
Agency:
Gustave Roussy, Cancer Campus, Grand Paris
Agency class:
Other
Source:
Gustave Roussy, Cancer Campus, Grand Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05874063
