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NCT06418789

High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors

N.N. Petrov National Medical Research Center of Oncology·Phase 2·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Germ Cell Tumor
Drug/Device/Intervention
High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
N.N. Petrov National Medical Research Center of Oncology
Location
Saint Petersburg, Russian Federation
Timeline & enrollment
Phase
Phase 2
Start date
Mar 01, 2024
End date
Mar 01, 2029
Enrollment
25 participants
Primary outcome

Progression Free Survival (PFS)

Summary

This is a prospective, single-center, non-randomized phase II study. Patients with germ cell
 tumors of gonadal and extragonadal localization who have progressed after prior
 platinum-containing first-line chemotherapy will receive high-dose chemotherapy with TI (2
 cycles) folollowed by high dose CE chemotherapy with autologous stem cell transplantation (3
 cycles). The primary endpoint of the study is to evaluate the efficacy high-dose chemotherapy
 as second-line drug therapy for patients with advanced germ cell tumors.

ICD-10 classifications
Malignant neoplasmsMalignant neoplasm: JejunumMalignant neoplasm: PrepuceMalignant neoplasm: Female genital organ, unspecifiedMalignant neoplasm: Vulva, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06418789
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06418789 through Pure Global AI's free database. This Phase 2 trial is sponsored by N.N. Petrov National Medical Research Center of Oncology and is currently Recruiting. The study focuses on Germ Cell Tumor. Target enrollment is 25 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.