Trials / Completed
CompletedNCT02047201
Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC
Assessing Tumor Response and IMRT Treatment Planning After Induction Chemotherapy Based on FDG-PET/CT for Locally Advanced Head and Neck Squamous Cell Carcinoma.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Lithuanian University of Health Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and efficacy of cisplatin plus intensity-modulated radiotherapy (IMRT) based on FDG-PET/CT after induction chemotherapy (IC) for locally advanced head and neck squamous cell carcinoma.
Detailed description
Current guidelines define that pre-IC target volumes must be used for radiotherapy (RT) planning. This prospective, phase II trial assessed the results of patients with locally advanced squamous cell carcinoma of head and neck treatment with IC following by chemoradiotherapy (CRT), using post-IC PET/CT images for IMRT planning.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | IMRT | IMRT treatment planning using FDG-PET/CT images after induction chemotherapy (IC). |
| RADIATION | PET/CT | Assessing tumor response using FDG-PET/CT. |
| DRUG | Docetaxel | 75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3. |
| DRUG | Fluorouracil | 750 mg/m2 continuous infusion for 120 h IV (in the vein) every 3 weeks. Number of cycles: 3. |
| DRUG | Cisplatin | 75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3. |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2016-01-01
- Completion
- 2016-01-01
- First posted
- 2014-01-28
- Last updated
- 2016-03-02
Locations
1 site across 1 country: Lithuania
Source: ClinicalTrials.gov record NCT02047201. Inclusion in this directory is not an endorsement.