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Personalized chemo dosing aims to beat tough testicular cancers

NCT ID NCT00864318

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested a high-dose chemotherapy regimen called TICE in 101 patients with germ cell tumors that had relapsed or were not responding to standard treatment. The approach uses two cycles of paclitaxel and ifosfamide followed by three cycles of carboplatin and etoposide, with carboplatin doses adjusted for each patient to reduce side effects. The goal was to improve complete response rates while controlling toxicity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Paclitaxel, ifosfamide, carboplatin, and etoposide (chemotherapy drugs)
What this could lead to
If successful, this could offer a more effective treatment option for patients with hard-to-treat germ cell tumors, potentially improving survival rates.
What could go wrong
This is a phase 2 trial with a small number of participants, so results may not apply to everyone. High-dose chemotherapy carries serious risks like ear toxicity and kidney damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

101 people

The number who actually took part.

Started

Mar 2009

Finished

Oct 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Germ cell tumors whatever histology (TGNS or séminoma : TGS ) whose origin is gonadic, extra-gonadic, retro-peritoneal or primitive mediastinal 2. Age \>= 18 years old 3. Histologically confirmed germ cell tumor (TGS) or biomarkers rate allowing to diagnose germ cell tumor without histology (TGNS) 4. Relapse or progression with bad prognosis in 1st treatment line : One of these criteria valid point 4 : progression after incomplete clinical response (Stable disease) to a Cisplatin basis chemotherapy; biomarker progression 4 weeks following the last chemotherapy cycle administration; progression during the first treatment line without obtention of at least stable disease; primitive mediastinal origin in first relapse. 5. TGNS or TGS in relapse after 2 treatment lines 6. Disease progression ( previous points 4 or 5) documented by : tumors biomarkers increase (AFP and/or HCG) if no, a biopsy is needed to confirm presence of tumors active cells 7. ECOG Performance status 0-2 8. Biological Function : Neutrophils \>= 1500/mm3, Platelets \>= 150.000/mm3 ; normal creatinine (or clearance \>= 50 ml/mn) ; SGOT, SGPT \<= 2,5N (or 5N if hepatic metastases), Bilirubin \< 1,5N 9. Cardiac Functions (FEV \>= 50%), Respiratory Functions , neurological Functions compatibles with high dose chemotherapy administration 10. Absence of previous intensification 11. Patient Information and Informed consent signature 12. HIV and B and C hepatitis negative serologies 13. Negative pregnancy test for women with reproductive potential and adequate contraception before study entry 14. Patient affiliated to social security system Exclusion Criteria: 1. Patients whose diagnosis of relapse was not confirmed by an anatomopathological examination or by an increase of tumors markers 2. Primitive encephalic germ cell tumors 3. Germ cell tumors in relapse with favorable factors of treatment response to conventional chemotherapy (RC sustainable after Cisplatin): prior cRC or incomplete clinical response but with normalization of markers and testicular origin 4. Growing Teratoma lesions 5. Patients with HIV infection, hepatitis B and C 6. Patients with symptomatic brain metastases despite appropriate corticosteroid treatment 7. Associated pathology may prevent the patient to receive treatment, creatinine clearance ≤ 50 mL / min (calculated by Cockcroft-Gault) 8. FEV \<50% 9. History of cancer (except basal cell epithelioma skin cancer) in the 3 years preceding the entry into the trial 10. Patient already included in another clinical trial involving an experimental molecule 11. Pregnant or breast feeding women 12. Persons without liberty or under guardianship, 13. Geographical, social or psychological conditions that do not permit compliance with protocol

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Conditions

The condition(s) this trial relates to.

germ cell tumor Neoplasms, Germ Cell and Embryonal Recurrence testis refractory cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHU

    Clermont-Ferrand, 63003, France

  • CHU

    Strasbourg, 67091, France

  • Centre Antoine Lacassagne

    Nice, 06050, France

  • Centre Léon Bérard

    Lyon, 69373, France

  • Centre Paul Papin

    Angers, 49933, France

  • Hopital St André

    Bordeaux, 33075, France

  • Hopital TENON

    Paris, 75970, France

  • Institut Bergonié

    Bordeaux, 33076, France

  • Institut Claudius Regaud

    Toulouse, 31052, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Paoli Calmette

    Marseille, 13273, France

  • Institut Val d'aurelle

    Montpellier, 34298, France

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