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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

ConditionGerm Cell Cancer Metastatic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age16+
SponsorBlokhin's Russian Cancer Research Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Primary mediastinal NSGCT or

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Paclitaxel

    Drug

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

  • Bleomycin

    Drug

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

  • Etoposide

    Drug

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

  • Cisplatin

    Drug

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

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: T-BEPExperimental treatment 5 interventions
Group B: BEPActive comparator 4 interventions

Trial outcomes

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 frame
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

1

Overall Survival

OS is defined as time from enrollment to death due to any cause

Time frame
Time from enrollment to death due to any cause, or data cut-off date, whichever occurred first (up to ~60 months)
2

Complete response rate (CRS)

CRS is defined as normalization of tumor markers and no clinical or radiological evidence of disease

Time frame
Time from enrollment to completion of the 4th cycle of chemotherapy, disease progression, or death, whichever occurs first (up to ~48 months)
3

Pathological complete response (pCR)

pCR is defined as normal tumor markers and completely resected residual masses containing only necrosis or teratoma

Time frame
Time from enrollment to death due to any cause, or data cut-off date, whichever occurred first (up to ~60 months)
4

Adverse events

Safety per CTCAE v5.0.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Blokhin's Russian Cancer Research Center

Lead sponsor

N.N. Petrov National Medical Research Center of Oncology

Collaborator

National Medical Research Radiological Centre of the Ministry of Health of Russia

Collaborator

Moscow Multidisciplinary Clinical Center "Kommunarka"

Collaborator

Source ClinicalTrials.gov
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