Clinical trial · Interventional
First Line TIP in Poor Prognosis TGCTs.
A Treatment Strategy of the Use of 1st Line Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors Based on Tumor Marker Decline: A Phase II Trial of Paclitaxel, Ifosfamid and Cisplatin Regimen.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intravenous chemotherapy
- description
- TIP regimen: * Paclitaxel 250 mg/ m2 iv on day 1 * Ifosfamide 1,2 g/ m2/ day iv x 5 days * Cisplatin 20 mg/ m2/ day iv x 5 days
- interventionNames
- Drug: Paclitaxel
- Drug: Ifosfamide
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- 36 month
- description
- according RECIST criteria version 1.1
Secondary outcomes (4)
- measure
- Response rate
- timeFrame
- 36 month
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available