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Study Comparing Chemotherapy with Paclitaxel, Ifosfamide, and Cisplatin versus High-Dose Chemotherapy with Paclitaxel and Drug Combination for Relapsed Germ Cell Tumors

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What is this study about?

This clinical trial is focused on studying germ cell tumors, which are a type of cancer that can occur in the reproductive cells. The trial is comparing two different chemotherapy treatments for patients whose tumors have returned or are not responding to initial treatment. The first treatment option uses a combination of Paclitaxel, Ifosfamide, and Cisplatin (referred to as TIP), while the second option involves a high-dose chemotherapy approach using Paclitaxel and Ifosfamide followed by high doses of Carboplatin and Etoposide (referred to as TI-CE). The purpose of the study is to compare the overall survival of patients receiving these treatments.

Participants in the study will receive their assigned treatment through intravenous infusions, which means the medication is given directly into a vein. The study will monitor patients over a period of time to assess their response to the treatment and any side effects they may experience. The trial aims to determine which treatment is more effective in improving survival rates for patients with relapsed or refractory germ cell tumors.

Throughout the study, patients will be closely monitored by healthcare professionals to ensure their safety and to manage any potential side effects. The trial will also collect data on progression-free survival, which measures the length of time during and after treatment that a patient lives with the disease without it getting worse, as well as the overall response rate to the treatments. This information will help doctors understand the benefits and risks of each treatment option for patients with this type of cancer.

1 randomization

Upon joining the study, the patient is randomly assigned to one of two treatment groups. This process is called randomization and ensures that each patient has an equal chance of receiving either treatment regimen.

2 treatment group assignment

The patient is assigned to either the conventional-dose chemotherapy group or the high-dose chemotherapy group. The conventional-dose group receives a combination of paclitaxel, ifosfamide, and cisplatin (TIP). The high-dose group receives paclitaxel and ifosfamide followed by high doses of carboplatin and etoposide (TI-CE).

3 chemotherapy administration

Chemotherapy drugs are administered through a vein, a process known as intravenous use. The specific schedule and dosage depend on the treatment group assignment.

For the TIP regimen, the patient receives paclitaxel, ifosfamide, and cisplatin in a conventional dose. The exact frequency and duration are determined by the study protocol.

For the TI-CE regimen, the patient first receives paclitaxel and ifosfamide to mobilize stem cells, followed by high doses of carboplatin and etoposide.

4 monitoring and follow-up

Throughout the treatment, the patient’s health and response to the chemotherapy are closely monitored. This includes regular blood tests and imaging studies to assess the tumor’s response.

The patient is also monitored for any side effects or complications related to the treatment.

5 end of treatment evaluation

At the end of the treatment period, the patient’s overall response to the chemotherapy is evaluated. This includes assessing the tumor’s size and any changes in the patient’s health status.

The primary goal is to determine the overall survival and progression-free survival, as well as any treatment-related effects.

Who Can Join the Study?

  • Must have a confirmed diagnosis of a germ cell tumor (GCT), which is a type of cancer that can start in different parts of the body.
  • Must test negative for certain infections, including HIV, HTLV, Hepatitis B, and Hepatitis C.
  • Must agree not to father a child during the study and for about 6 months after, using effective birth control methods.
  • Must provide written consent to participate in the study, following specific guidelines and regulations.
  • Must show evidence of a progressive or recurrent GCT after receiving one type of chemotherapy that includes cisplatin. This means the cancer has come back or is growing again.
  • Must have received 3 to 6 cycles of cisplatin-based chemotherapy as the first treatment.
  • Must not have had more than one previous type of chemotherapy for GCT, except for one cycle of a different treatment.
  • Must have recovered well from any previous surgery, such as having a healed scar and being able to eat normally.
  • Must be at least 14 years old, with specific age requirements in different countries.
  • Must be male.
  • Must have a good general health status, as measured by the ECOG Performance Status, which ranges from 0 to 2.
  • Must have certain initial laboratory test results, including:
    • Absolute Neutrophil Count (ANC) of at least 1,500/mm3
    • Platelet Count of at least 100,000/mm3
    • Creatinine Clearance of at least 50 mL/min, which measures kidney function
    • Bilirubin level no more than 2 times the normal upper limit, which checks liver function
    • AST/ALT levels no more than 2.5 times the normal upper limit, which also checks liver function

Who Cannot Join the Study?

  • Patients who do not have a progressive or recurrent germ cell tumor. This means the tumor is not growing or coming back after treatment.
  • Patients who are not male. Only male patients can participate in this study.
  • Patients who are part of a vulnerable population. This refers to groups of people who might need special protection or care, such as children or those unable to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Institut Jules Bordet Anderlecht Belgium
Netherlands Cancer Institute Amsterdam The Netherlands
Hospital Universitario 12 De Octubre Madrid Spain
Hospital General Universitario Morales Meseguer Murcia Spain
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Philipps-Universitaet Marburg Marburg Germany
Rotkreuzklinikum Muenchen gGmbH Munich Germany
Rigshospitalet Copenhagen Denmark
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Cbmcjy Lxyt Beyuoe Lyon France
Uupevaacty Mjjctxi Cimvgy Hfymvqwfjubzcnlek Hamburg Germany
Umvyhuymlhmfnqurprgcx Exfww Aqu Essen Germany
Irrpayvw Cukuyh Dfokxugjmzizijdol L'hospitalet De Llobregat Spain
Uetjkbyhtazbclgwqkgny Duewgyakmnm Azf Duesseldorf Germany
Hffrbgtd Dq Lj Sfzrb Crya I Scmw Pci Barcelona Spain
Iyedpnup Pfcqfjheiktayaa Cgiumz Cwmfxb Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
22.12.2016
Denmark Denmark
Not recruiting
22.12.2016
France France
Not recruiting
22.12.2016
Germany Germany
Not recruiting
22.12.2016
Ireland Ireland
Not recruiting
22.12.2016
Italy Italy
Not recruiting
22.12.2016
Spain Spain
Not recruiting
22.12.2016
The Netherlands The Netherlands
Not recruiting
22.12.2016

Trial locations

Investigated drugs:

Paclitaxel is a medication used in chemotherapy that helps stop the growth of cancer cells. It is part of the treatment regimen in this trial to help manage germ cell tumors.

Ifosfamide is another chemotherapy drug that works by interfering with the DNA of cancer cells, preventing them from multiplying. It is used in combination with other drugs in this trial.

Cisplatin is a chemotherapy medication that damages the DNA in cancer cells, which can lead to cell death. It is used in the conventional-dose chemotherapy regimen in this study.

Carboplatin is similar to cisplatin and is used in high-dose chemotherapy. It also works by damaging the DNA of cancer cells, helping to stop their growth.

Etoposide is a chemotherapy drug that prevents cancer cells from dividing and growing. It is used in the high-dose chemotherapy regimen in this trial.

TI-CE Regimen refers to a combination of high-dose chemotherapy drugs, including paclitaxel, ifosfamide, carboplatin, and etoposide, used in this study to treat relapsed or refractory germ cell tumors.

TIP Regimen is a conventional-dose chemotherapy treatment that includes paclitaxel, ifosfamide, and cisplatin, used as a comparison in this trial to evaluate its effectiveness against the high-dose regimen.

Germ Cell Tumor – Germ cell tumors are a type of cancer that begins in the cells that give rise to sperm or eggs. These tumors can occur in the ovaries or testes, but they can also appear in other areas of the body. The disease can be progressive or recurrent, meaning it can continue to grow or return after treatment. Germ cell tumors can be either measurable, where the tumor size can be quantified, or non-measurable, where the tumor is present but not easily quantified. The progression of the disease can vary, with some tumors growing slowly and others more rapidly.

Trial ID:
2024-513509-30-00
Protocol code:
1407-GUCG
NCT ID:
NCT02375204
Trial Phase:
Therapeutic confirmatory (Phase III)

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