Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

Germ Cell Tumor Clinical Trial

— GIG-T  

Official title:

Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874063
• Other study ID #: 2022-502426-41-00
• Secondary ID: CSET 2022/3510
• Status: Recruiting
• Phase: Phase 3
• Start date: October 17, 2023
• Est. completion date: February 2028

Study information

• Verified date: March 2024
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Thibault RAOULT, MSc
• Phone: +33 (0)1 42 11 42 11
• Email: thibault.raoult[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 387
• Est. completion date: February 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Germ Cell Tumor
• Neoplasms, Germ Cell and Embryonal

Intervention

Drug:
• Thromboprophylaxis
Thromboprophylaxis in addition of the standard chemotherapy

Locations

Country	Name	City	State
France	ICO Paul Papin	Angers
France	CH de la Côte Basque	Bayonne
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	Centre Oscar Lambret	Lille
France	CHU de Limoges	Limoges
France	Centre Léon Bérard	Lyon
France	Centre Antoine Lacassagne	Nice
France	CHU de Poitiers	Poitiers
France	Clinique La Croix du Sud	Quint-Fonsegrives
France	Centre Eugène Marquis	Rennes
France	HIA Bégin	Saint-Mandé
France	ICANS	Strasbourg
France	CHU Bretonneau	Tours
France	Institut de Cancérologie de Lorraine	Vandoeuvre les nancy
France	Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.