Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Head and neck cancer, PET/CT, induction chemotherapy, IMRT
Brief 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.
Interventions
RADIATIONIMRT
IMRT treatment planning using FDG-PET/CT images after induction chemotherapy (IC).
RADIATIONPET/CT
Assessing tumor response using FDG-PET/CT.
DRUGDocetaxel
75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.
DRUGFluorouracil
750 mg/m2 continuous infusion for 120 h IV (in the vein) every 3 weeks. Number of cycles: 3.
DRUGCisplatin
75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.
Sponsors
Lithuanian University of Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 24 months after treatment | PFS was defined as the time from the first day of IC first cycles to either progression or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumour metabolic response (MTV) reduction (%) | 2 weeks after IC | MTV was defined as the tumor volume with FDG uptake segmented by a gradient-based method and fixed threshold methods at \>40% of SUVmax. The MTV predictive value for tumor response to IC was assessed by comparing MTV's reduction (MTV of second PET/CT difference from MTV of first PET/CT in percent) in IC responders versus non responders and correlation with PFS and OS. |
| Total lesion glycolysis (TLG) reduction (%) | 2 weeks after IC | The TLG was defined as (MTV) x (SUVmean). The TLG predictive value for tumor response to IC was assessed by comparing TLG reduction (TLG of second PET/CT difference from TLG of first PET/CT in percent) in IC responders versus non responders and correlation with PFS and OS. |
| SUVmax reductions (%) | 2 weeks after IC | The SUVmax was defined as (tissue activity) (mcCi/ml)/(injected dose) (mCI)/(patient weight) (kg) within the voxel having the highest activity within a given region of interest (ROI). The SUVmax predictive value for tumor response to IC was assessed by comparing reductions in SUVmax (SUVmax of second PET/CT difference from SUVmax of first PET/CT in percent) in IC responders versus non responders and correlation with PFS and OS. |
| Number (%) of participants with adverse events | 12 and 24 months from chemoradiotherapy | Treatment acute toxicity during IC and CRT (chemoradiotherapy) was weekly assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) v.4.0. Late adverse events related with radiotherapy were assessed every three months after CRT using RTOG (Radiation Therapy Oncology Group) /EORTC (European Organization for Research and Treatment of Cancer) toxicity criteria. |
| Overall survival (OS) | 24 months after treatment | OS was defined as the time from the first day of IC first cycles until death from any cause. |
Countries
Lithuania
Outcome results
None listed