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NCT00864318: TICE
Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis
Phase 2 trial testing Paclitaxel in Germ Cell Tumors in 101 participants. Completed in 5 October 2020.
5 October 2020
Quick facts
| Lead sponsor | Institut Claudius Regaud |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 101 |
| Start date | 13 March 2009 |
| Primary completion | 5 October 2020 |
| Estimated completion | 5 October 2020 |
| Sites | 12 locations across France |
Drugs / interventions tested
- Paclitaxel — full drug profile →
- Ifosfamide (IFOSFAMIDE) — full drug profile →
- Carboplatine
- Etoposide (etoposide) — full drug profile →
- cytapheresis + transfusion of autologous peripheral blood stem cells
Conditions studied
- Germ Cell Tumors — all drugs for Germ Cell Tumors →
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):
-
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
Verify or expand the search:
- PubMed search for NCT00864318
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Germ Cell Tumors
Currently open trials in the same condition.
- NCT05092451 — Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting C · Phase 1, PHASE2 · recruiting
Other Institut Claudius Regaud trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00864318 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut Claudius Regaud
- Last refreshed: 14 April 2026
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing