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NCT00864318: TICE

Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis

Completed Phase 2 Last updated 14 April 2026
What this trial tests

Phase 2 trial testing Paclitaxel in Germ Cell Tumors in 101 participants. Completed in 5 October 2020.

Timeline
13 March 2009
Primary endpoint
5 October 2020
5 October 2020

Quick facts

Lead sponsorInstitut Claudius Regaud
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment101
Start date13 March 2009
Primary completion5 October 2020
Estimated completion5 October 2020
Sites12 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Institut Claudius Regaud — full company profile →

Who can join

18 and older, any sex, with Germ Cell Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Not randomized, multicentric, national phase II trial estimating the efficacy of an intensification protocol in patients with refractory germ cell tumors with relapse and bad prognosis. Treatment consists in two Paclitaxel and Ifosfamide intensification cycles followed by three Carboplatine and Etoposide high dose cycles. The point is the individual Carboplatine adjustment to take into account inter-individual patients variability. This adaptation allow to control each patient plasmatic exposition to avoid both inacceptable toxicities (such as ear toxicity) and a low exposition losing then the benefit of this high dose protocol.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Multicentric phase II trial of TI-CE high-dose chemotherapy with therapeutic drug monitoring of carboplatin in patients with relapsed advanced germ cell tumors.
    Chevreau C, Massard C, Flechon A, Delva R, et al · · 2021 · cited 4× · PMID 33675184 · DOI 10.1002/cam4.3687

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Other trials of Paclitaxel

Trials testing the same drug.

Other recruiting trials for Germ Cell Tumors

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Other Institut Claudius Regaud trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00864318.

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