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

Phase 2CompletedNCT02047201

Lithuanian University of Health Sciences40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

IMRTRADIATION

IMRT treatment planning using FDG-PET/CT images after induction chemotherapy (IC).

PET/CTRADIATION

Assessing tumor response using FDG-PET/CT.

DocetaxelDRUG

75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lithuanian University of Health Sciences

Kaunas, Lithuania

Outcomes

Primary Outcomes

Progression free survival (PFS)

PFS was defined as the time from the first day of IC first cycles to either progression or death.

Time frame: 24 months after treatment

Secondary Outcomes

Tumour metabolic response (MTV) reduction (%)

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.

Time frame: 2 weeks after IC

Total lesion glycolysis (TLG) reduction (%)

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.

Time frame: 2 weeks after IC

SUVmax reductions (%)

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.

Time frame: 2 weeks after IC

Number (%) of participants with adverse events

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.

Data from ClinicalTrials.gov

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