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

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.

Full Title of Study: “Assessing Tumor Response and IMRT Treatment Planning After Induction Chemotherapy Based on FDG-PET/CT for Locally Advanced Head and Neck Squamous Cell Carcinoma.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

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

  • Radiation: IMRT
    • IMRT treatment planning using FDG-PET/CT images after induction chemotherapy (IC).
  • Radiation: PET/CT
    • Assessing tumor response using FDG-PET/CT.
  • Drug: Docetaxel
    • 75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.
  • Drug: Fluorouracil
    • 750 mg/m2 continuous infusion for 120 h IV (in the vein) every 3 weeks. Number of cycles: 3.
  • Drug: Cisplatin
    • 75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.

Arms, Groups and Cohorts

  • Experimental: Experimental
    • Induction chemotherapy (Docetaxel, Cisplatin and Fluorouracil) following radiochemotherapy (IMRT using PET/CT images after IC for treatment planning + cisplatin iv 40 mg/m2 weekly).

Clinical Trial Outcome Measures

Primary Measures

  • Progression free survival (PFS)
    • Time Frame: 24 months after treatment
    • PFS was defined as the time from the first day of IC first cycles to either progression or death.

Secondary Measures

  • Tumour metabolic response (MTV) reduction (%)
    • Time Frame: 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 (%)
    • Time Frame: 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 (%)
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 24 months after treatment
    • OS was defined as the time from the first day of IC first cycles until death from any cause.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lithuanian University of Health Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ilona Kulakiene, Professor – Lithuanian University of Health Sciences
  • Overall Official(s)
    • Ilona Kulakiene, Prof., Principal Investigator, Lithuanian University of Health Sciences

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.