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AzTrials

Germ Cell TumorPhase 3NCT02375204

Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors

A Phase 3 study testing paclitaxel, ifosfamide and cisplatin in people with Germ Cell Tumor and Teratoma, run by Alliance for Clinical Trials in Oncology at 125 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Read more about this study

Who is it for?
Ages 14 years and older, men only
Conditions the study is for
Germ Cell Tumor, Teratoma, Choriocarcinoma
What is being tested?
paclitaxel, ifosfamide and cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
125 sitesin 12 countries
Study dates
6 Aug 2015to 1 Jun 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult
  1. Documentation of Disease
  • Histologic Documentation: Confirmation of GCT histology (both seminoma and nonseminoma) on pathologic review at the center of enrollment.
  • Tumor may have originated in any primary site. NOTE: In rare circumstances, patients will be allowed to enroll even if a pathologic diagnosis may not have been established.
  • This would require a clinical situation consistent with the diagnosis of GCT (testicular, peritoneal, retroperitoneal or mediastinal mass, elevated tumor marker levels {HCG ≥ 500; AFP ≥ 500} and typical pattern of metastases)
  1. Evidence of Disease
  • Must have evidence of progressive or recurrent GCT (measurable or non-measurable) following one line of cisplatin-based chemotherapy, defined as meeting at least one of the following criteria:
  • Tumor biopsy of new or growing or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for adjuvant treatment after macroscopically complete resection of viable GCT is not allowed). In the event of an incomplete gross resection where viable GCT is found, patients will be considered eligible for the study.
  • Consecutive elevated serum tumor markers (HCG or AFP) that are increasing. Increase of an elevated LDH alone does not constitute progressive disease.
  • Development of new or enlarging lesions in the setting of persistently elevated HCG or AFP, even if the HCG and AFP are not continuing to increase.
  1. Prior Treatment
  • Must have received 3-6 cycles of cisplatin-based chemotherapy as part of first-line (initial) chemotherapy.
  • Prior POMBACE, CBOP-BEP, or GAMEC are allowed.
  • Note: For patients requiring immediate treatment, 1 cycle of conventional-dose salvage chemotherapy is allowed. Therefore, these patients may have received 7 prior cycles of chemotherapy. 6 cycles as part of first-line chemotherapy and 1 cycle of salvage conventional chemotherapy.
  • No more than one prior line of chemotherapy for GCT (other than the 1 cycle of salvage chemotherapy as defined in the protocol)
  • Definition of one line of chemotherapy: One line of therapy can in some cases consist of 2 different cisplatin-based treatment combinations, provided there is no disease progression between these two regimens.
  • Prior treatment with carboplatin as adjuvant therapy is allowed, provided patients meet other eligibility criteria (e.g., the patient has also received 3-4 cycles of cisplatin-based chemotherapy).
  • Prior treatment with 1-2 cycles of BEP or EP as adjuvant chemotherapy for early stage GCT is allowed, provided the patient also received 3-4 cycles of BEP or EP again at relapse. Patients treated with 3-4 cycles of VIP at relapse following 1-2 cycles of BEP/EP are not eligible as this would be considered more than 1 line of prior therapy.
  • No prior treatment with high-dose chemotherapy (defined as treatment utilizing stem cell rescue)
  • No prior treatment with TIP with the exception when given as a bridge to treatment on protocol for patients with rapidly progressive disease who cannot wait to complete the eligibility screening process. Only one cycle is allowed.
  • No concurrent treatment with other cytotoxic drugs or targeted therapies.
  • No radiation therapy (other than to the brain) within 14 days of day 1 of protocol chemotherapy except radiation to brain metastases, which must be completed 7 days prior to start of chemotherapy.
  • No previous chemotherapy within 17 days prior to enrollment. A minimum of three weeks after the last day of the start of the previous chemotherapy regimen before the first day of chemotherapy on study protocol.
  • Must have adequate recovery from prior surgery (eg, healed scar, resumption of diet)
  1. Age ≥ 14 years (≥ 18 years in Germany)
  2. ECOG Performance Status 0 to 2
  3. Male gender
  4. Required Initial Laboratory Values:
  • Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3
  • Platelet Count ≥ 100,000/mm^3
  • Calculated creatinine clearance ≥ 50 mL/min
  • Bilirubin ≤ 2.0 x upper limits of normal (ULN)
  • AST/ALT ≤ 2.5 x upper limits of normal (ULN)
  1. No concurrent malignancy other than non-melanoma skin cancer, superficial noninvasive (pTa or pTis) TCC of the bladder, contralateral GCT, or intratubular germ cell neoplasia. Patients with a prior malignancy, but at least 2 years since any evidence of disease are allowed.
  2. Negative Serology (antibody test) for the following infectious diseases:
  • Human Immunodeficiency Virus (HIV) type 1 and 2
  • Human T-cell Leukemia Virus (HTLV) type 1 and 2 (mandatory in US but optional in Canada and Europe)
  • Hepatitis B surface antigen
  • Hepatitis C antibody
  1. No late relapse with completely surgically resectable disease. Patients with late relapses (defined as relapse ≥ 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable are not eligible. Patients with late relapses who have unresectable disease are eligible.
  2. No large (≥ 2 cm) hemorrhagic or symptomatic brain metastases until local treatment has been administered (radiation therapy or surgery). Treatment may begin ≥ 7 days after completion of local treatment. Patients with small (< 2 cm) and asymptomatic brain metastases are allowed and may be treated with radiation therapy and/or surgery concurrently with Arm A or cycles 1 and 2 of Arm B if deemed medically indicated. Radiation therapy should not be given concurrently with high-dose carboplatin or etoposide.
  3. No secondary somatic malignancy arising from teratoma (e.g., teratoma with malignant transformation) when it is actively part of the disease recurrence or progression.

Trial locations and contacts

125 sites in 12 countries.

125 sites in 12 countries

United States77 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • El Paso Children's Hospital

    El Paso, Texas, 79905

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, 32207

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota, 55404

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • The Children's Hospital at TriStar Centennial

    Nashville, Tennessee, 37203

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    Tampa, Florida, 33607

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

Other trials in United States

Germany11 sites

  • University of Berlin Charite Campus Benjamin Franklin

    Berlin, 12203

  • Technical University Dresden

    Dresden, Saxony, 01307

  • University of Dusseldorf

    Düsseldorf, 40225

  • University of Essen

    Essen, 45122

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

  • UniversitaetsKlinikum Heidelberg

    Heidelberg, 69120

  • GK-Mittelrhein Saint Martin's

    Koblenz, 56068

  • Philipps University Marburg

    Marburg, 35033

  • Rotkreuzklinikum Munchen

    Munich, 80634

  • Klinikum Nurnberg Nord

    Nuremberg, 90419

  • University Hospital Ulm

    Ulm, 89081

Other trials in Germany

United Kingdom8 sites

  • Beatson Oncology Center

    Glasgow, Scotland, G12 0YN

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • Christie Hospital

    Manchester, England, M20 4BX

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Weston Park Hospital

    Sheffield, England, S10 2SJ

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • The Royal Marsden NHS Foundation Trust - Sutton

    Surrey, SM2 5PT

  • Saint James's University Hospital

    West Yorkshire, England, LS9 7TF

Other trials in United Kingdom

France7 sites

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13273

  • Hopital Tenon/Assistance Publique - Hopitaux de Paris

    Paris, 75970

  • CHRU Strasbourg - Hospital Civil

    Strasbourg, 67091

  • Center Claudius Regaud

    Toulouse, 31052

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Australia4 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Italy4 sites

  • Ospedale di Circolo di Busto Arsizio

    Busto Arsizio, 21052

  • Istituto Scientifico Romagnolo

    Meldola, 47014

  • Istituto Nazionale Tumori

    Milan, 20133

  • San Matteo Hospital

    Pavia, 27100

Other trials in Italy

Spain4 sites

  • Hospital De La Santa Creu I Sant Pau

    Barcelona, 08025

  • Duran i Reynals Hospital-Catalan Institute of Oncology

    Barcelona, 08908

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

Other trials in Spain

Netherlands3 sites

  • The Netherlands Cancer Institute

    Amsterdam, 1066 CX

  • University Medical Center Groningen

    Groningen, 9700 GZ

  • Radboud University Nijmegen Medical Centre

    Nijmegen, 6500 HB

Other trials in Netherlands

Switzerland3 sites

  • Inselspital

    Bern, 3010

  • Hopitaux Universitaires de Geneve

    Geneva, 1211

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

Belgium2 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • University Hospital Saint Luc

    Brussels, 1200

Other trials in Belgium

Denmark1 site

  • Rigshospitalet University Hospital

    Copenhagen, 2100

Other trials in Denmark

Ireland1 site

  • Saint James Hospital

    Dublin, 8

Other trials in Ireland

About this study

Official title: A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

Read the detailed description

The study is an international collaboration with European sites. Collaborators on the study include the National Cancer Institute, the European Organization for Research and Treatment of Cancer and the Movember Foundation. Randomization will be stratified by region (North America and Europe) and by modified IPFSG (International Prognostic Factor Study Group) risk classification (low, intermediate and high). The primary and secondary objectives are described below.

Primary Objective:

  1. To compare the overall survival in patients treated with conventional-dose chemotherapy using the TIP regimen with high-dose chemotherapy (HDCT) plus autologous stem cell transplant (ASCT) using the TI-CE regimen as initial salvage treatment of patients with relapsed or refractory germ cell tumors (GCT)

Secondary Objectives:

  1. To compare the progression-free survival (PFS) of patients treated with initial salvage HDCT with TI-CE versus initial salvage CDCT with TIP
  2. To compare the favorable response rate (FRR) of patients treated with initial salvage HDCT with TI-CE versus initial salvage CDCT with TIP
  3. To compare the toxicity, including treatment-related mortality, associated with high-dose chemotherapy and ASCT using TI-CE compared with conventional-dose chemotherapy using TIP as initial salvage treatment for patients with relapsed or refractory GCT
  4. To prospectively evaluate the IPFSG scoring system as a predictor of outcome to initial salvage therapy in patients with relapsed or refractory GCT. In this trial, randomization will be stratified by a modification of their IPFSG category and we will prospectively evaluate whether or not actual outcomes vary by risk group in the appropriate manner (low risk patients have higher OS than high-risk group).
  5. To evaluate the association between tumor marker decline rates of Alpha-Fetoprotein (AFP) and Human Chorionic Gonadotropin (HCG) with OS and PFS.

Treatment is to continue until disease progression, unacceptable toxicity or completion of all protocol treatment.

Being tested
paclitaxel, ifosfamide, cisplatin, pegylated G-CSF, G-CSF
Medical subject headings
Neoplasms, Germ Cell and Embryonal, Teratoma, Choriocarcinoma, Germinoma, Endodermal Sinus Tumor, Nonseminomatous germ cell tumor, Seminoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • paclitaxelDrug

    Also called Taxol

    IV

  • ifosfamideDrug

    Also called Ifex®, IFOS

    IV

  • cisplatinDrug

    Also called CDDP

    IV

  • pegylated G-CSFDrug

    IV

  • G-CSFDrug

    IV

  • carboplatinDrug

    Also called Paraplatin®, CBDCA

    IV

  • etoposide phosphateDrug

    Also called VePesid®, Toposar®, VP16

    IV

  • stem cell reinfusionProcedure or surgery

    surgical procedure

Study groups in NCT02375204
Study groupRoleWhat they receive
Arm A: TIPOtherPatients will receive treatment for 4 cycles administered every 21 days. Cycles 1-4 (1 cycle = 21 days) * paclitaxel 250 mg/m^2 IV over 24 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker) * ifosfamide 1500 mg/m^2 IV daily on Days 2-5 with mesna protection as defined in the protocol * cisplatin 25 mg/m^2 IV daily on Days 2-5 * pegylated G-CSF 6 mg subcutaneous on Day 6 or 7 or G-CSF as defined in the protocol on Days 6-18 Patients may commence with each Arm A cycle provided they meet the criteria as defined in the protocol.
Receives: Drug: paclitaxel; Drug: ifosfamide; Drug: cisplatin; Drug: pegylated G-CSF; Drug: G-CSF
Arm B: TI-CEOtherPatients will receive treatment for a total of 5 cycles. Cycles 1-2 (1 cycle = 14 days) * paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker) * ifosfamide 2000 mg/m^2 IV daily on Days 1-3 with mesna protection as defined in the protocol * G-CSF 10 µg/kg subcutaneously on Days 3-15 (cycle 1) and Days 3-14 (cycle 2) or pegylated G-CSF 6 mg subcutaneous on Day 4 or 6 (cycle 1) and Day 4 or 5 (cycle 2) * leukapheresis every 14 days, if there is an inadequate number of CD34+ cells/kg collected in cycle 1 Cycles 3-5 (1 cycle = 21 days) * carboplatin daily on Days 1-3 * etoposide 400 mg/m^2 daily on Days 1-3 * stem cell reinfusion on day 5 * pegylated G-CSF 6 mg subcutaneously or G-CSF at approximately 5 µg/kg daily on Days 5-15 Patients may commence with each Arm B cycle provided they meet the criteria as defined in the protocol.
Receives: Drug: paclitaxel; Drug: ifosfamide; Drug: pegylated G-CSF; Drug: G-CSF; Drug: carboplatin; Drug: etoposide phosphate; Procedure: stem cell reinfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: Up to 36 months post-treatment

Secondary outcomes (5)

  1. progression free survival

    Measured: Up to 36 months post-treatment

  2. proportion of patients achieving either a complete response (CR) or partial response

    Measured: Up to 3 months post-registration

  3. treatment related mortality

    Measured: Up to 30 days post-treatment

  4. number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: Up to 3 months post-registration

  5. Validation of International Prognostic Factor Study Group stratification system (eg, primary site, prior response, progression free interval)

    Measured: Up to 3 years post-registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2015 (estimated)
  2. Study start6 Aug 2015
  3. Primary completion1 Jun 2031 (estimated)
  4. Study completion1 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02375204
Sponsor's protocol ID
A031102
Other IDs
U10CA180821, NCI-2014-01696
Status last verified
Jun 2026
First submitted
20 Feb 2015
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Gleeson JP, Knezevic A, Bromberg M, Patil S, Sheinfeld J, Carver BS, Bains M, Jones DR, Bajorin DF, Bosl GJ, McHugh DJ, Funt SA, Motzer RJ, Feldman DR. Paclitaxel, Ifosfamide, and Cisplatin as Initial Salvage Chemotherapy for Germ Cell Tumors: Long-Term Follow-Up and Outcomes for Favorable- and Unfavorable-Risk Disease. J Clin Oncol. 2024 Sep 10;42(26):3130-3139. doi: 10.1200/JCO.23.02542. Epub 2024 Jul 19.

    PubMed 39028926

  • Tan YY, Al-Bubseeree B, Irvine D, MacDonald G, McQuaker G, Parker A, Waterston A, White J. High-Dose Chemotherapy in Relapsed or Refractory Metastatic Germ-Cell Cancer: The Scotland Experience. Clin Genitourin Cancer. 2019 Apr;17(2):125-131. doi: 10.1016/j.clgc.2018.11.013. Epub 2018 Nov 17.

    PubMed 30563754

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing paclitaxel, ifosfamide and cisplatin in people with Germ Cell Tumor and Teratoma, run by Alliance for Clinical Trials in Oncology at 125 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States, Germany, United Kingdom, France, Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: Up to 36 months post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02375204, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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