Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors (NCT01873326)

🧪 Interventions in This Study

• Paclitaxel (DRUG)
• Ifosfamide (DRUG)
• Cisplatin (DRUG)
• Mesna (DRUG)
• Bleomycin (DRUG)
• Etoposide (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patients ≥ 18 years of age.
2. Patients with newly diagnosed GCT
3. Pathology confirmation of GCT histology at MSKCC or a collaborating treating institution. In exceptional circumstances, patients without pathological diagnosis may be included in the study following discussion with the national principal investigator, Dr. Feldman,(or national Co-PI or MSKCC Co-PI if the national PI is unavailable) if they meet the one of the following criteria:
4. Patients with a testicular mass (detected clinically and/or by ultrasound), and/or mediastinal or retroperitoneal lymphadenopathy or pineal tumor AND elevated serum tumor markers (HCG and/or AFP). Patients with elevated LDH only will not be included without pathological confirmation of GCT since LDH is a nonspecific marker for GCT and could potentially be elevated in other malignancies such as lymphomas. This is because patients may present with a clinical scenario consistent with GCT (elevated serum tumor markers, testicular mass and retroperitoneal lymphadenopathy) with a concurrent life-threatening oncologic emergency that require immediate treatment. In this case, initial treatment without biopsy confirmation is usually recommended and tissue confirmation may be obtained after initiating therapy.
5. Patients must have measurable or evaluable disease.
6. Patients must be classified as having intermediate or poor-risk germ cell tumor, as follows:
7. Intermediate-risk (Modified\*) a) Testis or retroperitoneal primary NSGCT with lymph node and/or lung metastasis but without non-pulmonary visceral metastasis AND any of the following pretreatment serum tumor marker (STM) values: i. Lactate dehydrogenase (LDH) from 3 to \<10 x ULN (\*This differs from the original IGCCCG criteria which includes patients with LDH from 1.5 to 10 x ULN). ii. Serum human chorionic gonadotrophin (HCG) from 5,000 to \< 50,000 MIU/mL iii. Serum alpha-fetoprotein (AFP) from 1,000 to \<10,000 ng/mL b) Seminoma histology regardless the primary site or serum tumor markers with any non-pulmonary visceral metastasis (liver, bone, brain, etc).
8. Poor-risk (any of the following):
9. Testis or retroperitoneal NSGCT primary with non-pulmonary visceral metastasis (liver, bone, brain, etc) regardless the STM values.
10. Mediastinal NSGCT primary site of disease regardless the presence/absence of visceral metastasis or STM values.
11. Testis or retroperitoneal NSGCT primary without non-pulmonary visceral metastasis but with poor-risk STM values:
12. i. LDH ≥ 10 x ULN

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (13 Sites)

• University of Southern California — Los Angeles, California
• Stanford University Medical Center — Stanford, California
• University of Chicago — Chicago, Illinois
• Mayo Clinic — Rochester, Minnesota
• Memorial Sloan Kettering Cancer Center — Basking Ridge, New Jersey
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey
• Memorial Sloan Kettering Bergen (Follow-up Only) — Montvale, New Jersey
• Memorial Sloan Kettering Cancer Center @ Suffolk — Commack, New York
• Memorial Sloan Kettering Westchester — Harrison, New York
• Memorial Sloan Kettering Cancer Center — New York, New York
• Memorial Sloan Kettering Nassau — Uniondale, New York
• University of North Carolina — Chapel Hill, North Carolina
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Germ Cell Tumors clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.