CompletedPhase 2

First Line TIP in Poor Prognosis TGCTs.

Slovakia19 participantsStarted 2015-04

Plain-language summary

TIP in the 1st line treatment of GCTs patients with unfavorable decline of serum tumor markers after 1 cycle of the BEP regimen.TIP will be administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients older than 16 years. * Evidence of NSGCT based on histologic examination or based on clinical evidence and high serum HCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are very elevated) * Testicular, retroperitoneal, or mediastinal primary site. * Evidence of disseminated disease (clinical stages II or III). * 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 previous carcinoma, except basal-cell carcinoma of the skin. * Adequate renal function: measured or calculated creatinine clearance\> 60 ml/min. * Absolute granulocyte count \>= 1,500/mm3, platelets \>= 100,000 mm3, bilirubine \<= 1.5 fold the upper normal value. * Unfavorable tumor marker decline after 1.cycle of BEP * Signed informed consent. Exclusion Criteria: * Patients infected by the Human Immunodeficiency Virus (HIV). * Patients who do not fit inclusion criteria.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete response rate

Timeframe: 36 month

Trial details

NCT IDNCT02414685

SponsorNational Cancer Institute, Slovakia

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2020-06

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