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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

Assessing Tumor Response and IMRT Treatment Planning After Induction Chemotherapy Based on FDG-PET/CT for Locally Advanced Head and Neck Squamous Cell Carcinoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047201
• Other study ID #: EHNCTE-1309
• Status: Completed
• Phase: Phase 2
• First received: January 22, 2014
• Last updated: March 1, 2016
• Start date: June 2013
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	PFS was defined as the time from the first day of IC first cycles to either progression or death.	24 months after treatment	No
Secondary	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.	2 weeks after IC	No
Secondary	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.	2 weeks after IC	No
Secondary	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.	2 weeks after IC	No
Secondary	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.	12 and 24 months from chemoradiotherapy	No
Secondary	Overall survival (OS)	OS was defined as the time from the first day of IC first cycles until death from any cause.	24 months after treatment	No