Paclitaxel-Bleomycin/Etoposide/Cisplatin vs Bleomycin/Etoposide/Cisplatin in Poor-prognosis Non-seminomatous Germ Cell Tumors (NSGCT) and Unfavorable Tumor Marker Decline: Randomized Phase II Trial

NCT07847190 | Recruiting Phase 2 DMC

• 1 other identifier: 200896130499
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

GETUG-13 study has prospectively confirmed poor outcomes in advanced germ cell tumors (GCT) patients with unfavorable decrease of tumor markers after 1 cycle of BEP chemotherapy. There is an unmet medical need to improve outcomes in this subset of patients, however the dose-dense regimen proposed in the above-mentioned trial cannot be implemented in routine clinical practice. T-BEP regimen may have advantage over the traditional BEP regimen as first-line therapy for poor-risk GCT Treatment escalation with T-BEP regimen may be an effective and tolerable therapeutic option for advanced GCT patients with unfavorable tumor markers decline.

Conditions

Germ Cell Cancer Metastatic

Keywords

testis cancer; germ cell tumor; poor-prognosis non-seminomatous germ cell tumors; unfavorable tumor marker decline

Outcome Measures

Primary Outcomes (1)

• 1-year progression-free survival (PFS)

  1-year PFS is defined as time from enrollment to disease progression or relapse or death due to any cause at 1 year (12-month PFS)

  Time from enrollment to disease progression or relapse or death due to any cause, or data cut-off date at 1 year, whichever occured first (up to ~60 months)

Secondary Outcomes (4)

• Overall Survival

  Time from enrollment to death due to any cause, or data cut-off date, whichever occurred first (up to ~60 months)

• Complete response rate (CRS)

  Time from enrollment to completion of the 4th cycle of chemotherapy, disease progression, or death, whichever occurs first (up to ~48 months)

• Pathological complete response (pCR)

  Time from enrollment to death due to any cause, or data cut-off date, whichever occurred first (up to ~60 months)

• Adverse events

  Time from enrollment to death due to any cause, or data cut-off date, whichever occurred first (up to ~60 months)

Study Arms (2)

T-BEP

EXPERIMENTAL

Participants receive 3 cycles of T-BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.

Drug: Paclitaxel; Drug: Bleomycin; Drug: Etoposide; Drug: Cisplatin; Drug: G-CSF (Filgrastim)

BEP

ACTIVE COMPARATOR

Participants receive 3 cycles of BEP after the first cycle of the BEP regimen and unfavorable tumor marker decline, followed by standard of care surgery. Each cycle is 21 days.

Drug: Bleomycin; Drug: Etoposide; Drug: Cisplatin; Drug: G-CSF (Filgrastim)

Interventions

Paclitaxel DRUG

Paclitaxel 175 mg/m\^2 IV infusion, Day 1, Q3W for 3 cycles in first line

T-BEP

Bleomycin DRUG

Bleomycin sulfate 30 mg IV infusion, Days 1,3,5, Q3W for 4 cycles in first line

BEP; T-BEP

Etoposide DRUG

Etoposide 100 mg/m\^2 IV infusion, Days 1-5, Q3W for 4 cycles in first line

Also known as: VP-16

BEP; T-BEP

Cisplatin DRUG

Cisplatin 20 mg/m\^2 IV infusion, Days 1-5, Q3W for 4 cycles in first line

BEP; T-BEP

G-CSF (Filgrastim) DRUG

G-CSF 5 mcg/kg subcutaneous, on Day 6, until post-nadir absolute neutrophil count ≥ 1.0 x 10\^9, Q3W for 4 cycles in first line

Also known as: Zarzio, Tevagrastim, Neupomax

BEP; T-BEP

Eligibility Criteria

• Age: 16 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥16 years;
• Evidence of NSGCT based on histologic examination or clinical evidence (high serum HCG or AFP levels - in case of clinical emergency due to bulky disease, therapy can be started without pathological confirmation of the disease);
• Testicular, retroperitoneal, or mediastinal primary site;
• Disease classified as poor prognosis according to IGCCCG criteria:
• Primary mediastinal NSGCT or
• Non-pulmonary visceral metastases or
• HCG \> 50,000 UI/l, or AFP \> 10,000 ng/ml, or LDH \> 10 times the upper normal value.
• No prior chemotherapy;
• No concurrent malignancies which may have an impact of anticipated lifespan (ie, malignancies other than basal-cell skin carcinoma, in situ carcinomas, borderline ovarian tumors etc);
• Adequate renal function: measured or calculated glomerular filtration rate \> 60 ml/min.
• Absolute baseline granulocyte count ≥0.5\*10\^9, platelets ≥100\*10\^9, bilirubin ≤1.5 ULN.
• Unfavorable tumor marker decline after 1st cycle of standard BEP chemotherapy calculated according to time to normalization from the K. Fizazi study in JCO 2004.
• Signed informed consent before protocol-specific procedures.

You may not qualify if:

• Primary intracranial germ-cell tumors;
• Patients with seminomas or dysgerminomas;
• Patients with normal range of serum tumor markers before starting treatment;
• Patients with favorable tumor markers decline;
• Patients infected by the Human Immunodeficiency Virus (HIV);
• Patients with contraindications to taxane agents (hypersensitivity to paclitaxel);

Sponsors & Collaborators

• Moscow Multidisciplinary Clinical Center "Kommunarka": collaborator
• Blokhin's Russian Cancer Research Center: lead
• N.N. Petrov National Medical Research Center of Oncology: collaborator
• National Medical Research Radiological Centre of the Ministry of Health of Russia: collaborator

Study Sites (1)

N.N. Blokhin National Medical Research Center of Oncology

Moscow, 115522, Russia

RECRUITING

MeSH Terms

Conditions

Testicular Neoplasms; Neoplasms, Germ Cell and Embryonal

Interventions

Paclitaxel; Bleomycin; Etoposide; Cisplatin; Granulocyte Colony-Stimulating Factor; Filgrastim

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Colony-Stimulating Factors; Glycoproteins; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors

Central Study Contacts

Edgar Israelyan, PhD

CONTACT

+7-919-879-92-54; e.israelyan@yandex.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

RU (1)