Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lithuanian University of Health Sciences
• Treatments: Cisplatin; Docetaxel; Fluorouracil

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.