RecruitingPhase 2

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

Russia25 participantsStarted 2024-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Patient is able to provide informed consent and sign approved consent forms to participate in the study.
✓. Males ≥ 18 years of age at the time of signing the IC Form.
✓. Histologically verified diagnosis of GO (seminomatous, non-seminomatous).

Exclusion criteria

✕. Primary CS of the brain
✕. Administration of ≥2 lines of prior drug therapy for disseminated GO.
✕. Presence of active hepatitis B or hepatitis C, HIV infection, acute infectious disease, or activation of chronic infectious disease less than 28 days prior to study inclusion.
✕. Conditions that limit the patient's ability to fulfill the requirements of the protocol (psychiatric disorders, drug or alcohol dependence).

What they're measuring

Progression Free Survival (PFS)

Timeframe: Up to 24 months post-treatment

Trial details

NCT IDNCT06418789

SponsorN.N. Petrov National Medical Research Center of Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-03-01

Contact for this trial

Anna Semenova, MD, PhD

8 (812) 439-95-05 mirannia@yandex.ru

View on ClinicalTrials.gov More Germ Cell Tumor trials