Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC
Conditions
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
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: IMRT Type: Radiation
Name: PET/CT Type: Radiation
Name: Docetaxel Type: Drug
Name: Fluorouracil Type: Drug
Name: Cisplatin Type: Drug
Overall Status
Recruiting
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.
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.
Location
Lithuanian University of Health Sciences
Kaunas, Lithuania
Status: Recruiting
Contact: Remigijus Zaliunas, Professor - +37037327200 - rektoratas@lsmuni.lt
Start Date
November 2013
Completion Date
December 2016
Sponsors
Lithuanian University of Health Sciences
Source
Lithuanian University of Health Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page