Clinical trial NCT02414685: First Line TIP in Poor Prognosis TGCTs.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Germ Cell Tumor
Keywords: poor-prognosis germ cell cancer, paclitaxel, ifosfamid and cisplatin regimen, tumor marker decline
Lead sponsor: National Cancer Institute, Slovakia
Sponsor class: OTHER_GOV
First posted: 2015-04-13
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Cycle 1: BEP regimen

Serum tumor markers at day 18-21:

•Patients with an unfavorable pattern of tumor marker decrease after 1 cycle of BEP will receive 4 more cycles of TIP.

TIP regimen:

* Taxol 250 mg/ m2 iv on day 1
* Ifosfamid 1,2 g/ m2/ day iv x 5 days
* Cisplatin 20 mg/ m2/ day iv x 5 days One cycle of therapy consists of 22 days. Estimated duration of treatment: Until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete response rate
timeFrame: 36 month
Secondary outcomes:
measure: Response rate
timeFrame: 36 month
measure: Progression-free survival
timeFrame: 36 month
measure: Number of adverse events grade III and IV
timeFrame: 36 month
measure: overall survival
timeFrame: 36 months
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: National Cancer Institute
Study officials:
affiliation: National Cancer Institute, Slovakia
name: Michal Mego, Ass.prof
role: STUDY_CHAIR
References: