Trials / Terminated
TerminatedNCT00941135
Safety and Efficacy Study in Patients With Local Advanced Larynx/Hypolarynx Carcinoma Treated With TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab
Phase II Study of TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab "Boost Concomitant" With Cetuximab in Patients With Local Advanced Larynx/Hypolarynx Carcinoma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Fundacion Miguel Servet · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the progression free time in patients with completed or partial response \> 30% evaluated over primary tumour (damage T and N) after induction TPF (Docetaxel, Cisplatin, 5-FU) treated with RT + Cetuximab over 2 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab | Docetaxel:75 mg/m2/d IV Cisplatin:75 mg/m2/d IV 5-FU:750 mg/m2/d IV TPF 3 cycles every 3 weeks Radiotherapy: Total 72 Gy in 42 fractions Cetuximab: 250 mg/m2/d Days 1, 8, 15, 22, 29, 36 and 43 |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2009-07-17
- Last updated
- 2011-09-29
Locations
4 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT00941135. Inclusion in this directory is not an endorsement.