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High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors - Trial NCT06418789

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.

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NCT06418789
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06418789
View on ClinicalTrials.gov
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High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors

Study Focus

Germ Cell Tumor

High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )

Interventional

drug

Sponsor & Location

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, Russian Federation

Timeline & Enrollment

Phase 2

Mar 01, 2024

Mar 01, 2029

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 neoplasms
Malignant neoplasm: Jejunum
Malignant neoplasm: Prepuce
Malignant neoplasm: Female genital organ, unspecified
Malignant neoplasm: Vulva, unspecified

Data Source

ClinicalTrials.gov

NCT06418789

Non-Device Trial