Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC
Head and Neck Squamous Cell Carcinoma
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Conditions: Keywords
Head and neck cancer, PET/CT, induction chemotherapy, IMRT
Study Type
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: IMRT Type: Radiation
Name: PET/CT Type: Radiation
Name: Docetaxel Type: Drug
Name: Fluorouracil Type: Drug
Name: Cisplatin Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Male or female patients aged 18 years or over;

- Histologically confirmed locally advanced (stage III and IV) head and neck squamous cell carcinoma (HNSCC);

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;

- Signed written informed consent approved by the Lithuanian Bioethics Committee (LBEC);

Exclusion Criteria:

- Positive serum pregnancy test in women of childbearing potential or breastfeeding;

- Presence of distant metastasis;

- Second primary tumor;

- History of other malignancy within the last 5 years;

- Recurrent head and neck cancer;

- Serious uncontrolled concomitant disease that would contraindicate the use of any drugs use in this study as chemotherapy or radiotherapy; ;

- Inadequate organ function, evidenced by the following laboratory results:

1. Absolute neutrophil count <1,500 cells/mm3;

2. Platelet count <100,000 cells/mm3;

3. Hemoglobin <9 g/dL;

4. Total bilirubin greater than the upper limit of normal (ULN);

5. AST (SGOT) or ALT (SGPT) >1,5 x ULN;

6. Alkaline phosphatase levels >2,5 x the ULN;

7. Serum creatinine >2,0 mg/dl or 177 umol/l.
Lithuanian University of Health Sciences
Kaunas, Lithuania
Status: Recruiting
Contact: Remigijus Zaliunas, Professor - +37037327200 -
Start Date
November 2013
Completion Date
December 2016
Lithuanian University of Health Sciences
Lithuanian University of Health Sciences
Record processing date processed this data on July 28, 2015 page