Personalized chemo dosing aims to beat tough testicular cancers
NCT ID NCT00864318
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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101 people
The number who actually took part.
- Started
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Mar 2009
- Finished
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Oct 2020
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU
Clermont-Ferrand, 63003, France
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CHU
Strasbourg, 67091, France
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Centre Antoine Lacassagne
Nice, 06050, France
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Centre Léon Bérard
Lyon, 69373, France
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Centre Paul Papin
Angers, 49933, France
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Hopital St André
Bordeaux, 33075, France
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Hopital TENON
Paris, 75970, France
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Institut Bergonié
Bordeaux, 33076, France
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Institut Claudius Regaud
Toulouse, 31052, France
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Institut Gustave Roussy
Villejuif, 94805, France
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Institut Paoli Calmette
Marseille, 13273, France
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Institut Val d'aurelle
Montpellier, 34298, France
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