search
Back to results

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

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Lithuania
Study Type
Interventional
Intervention
IMRT
PET/CT
Docetaxel
Fluorouracil
Cisplatin
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring Head and neck cancer, PET/CT, induction chemotherapy, IMRT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lithuanian University of Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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

Outcomes

Primary Outcome Measures

Progression free survival (PFS)
PFS was defined as the time from the first day of IC first cycles to either progression or death.

Secondary Outcome Measures

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.
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.
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.
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.
Overall survival (OS)
OS was defined as the time from the first day of IC first cycles until death from any cause.

Full Information

First Posted
January 22, 2014
Last Updated
March 1, 2016
Sponsor
Lithuanian University of Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT02047201
Brief Title
Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
Keywords
Head and neck cancer, PET/CT, induction chemotherapy, IMRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Induction chemotherapy (Docetaxel, Cisplatin and Fluorouracil) following radiochemotherapy (IMRT using PET/CT images after IC for treatment planning + cisplatin iv 40 mg/m2 weekly).
Intervention Type
Radiation
Intervention Name(s)
IMRT
Other Intervention Name(s)
intensity-modulated radiation therapy
Intervention Description
IMRT treatment planning using FDG-PET/CT images after induction chemotherapy (IC).
Intervention Type
Radiation
Intervention Name(s)
PET/CT
Other Intervention Name(s)
Positron emission tomography-computed tomography
Intervention Description
Assessing tumor response using FDG-PET/CT.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere, Docefrez
Intervention Description
75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.
Intervention Type
Drug
Intervention Name(s)
Fluorouracil
Other Intervention Name(s)
5-Fluorouracil, Adrucil
Intervention Description
750 mg/m2 continuous infusion for 120 h IV (in the vein) every 3 weeks. Number of cycles: 3.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol
Intervention Description
75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
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 Outcome Measure Information:
Title
Tumour metabolic response (MTV) reduction (%)
Description
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
Title
Total lesion glycolysis (TLG) reduction (%)
Description
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
Title
SUVmax reductions (%)
Description
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
Title
Number (%) of participants with adverse events
Description
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.
Time Frame
12 and 24 months from chemoradiotherapy
Title
Overall survival (OS)
Description
OS was defined as the time from the first day of IC first cycles until death from any cause.
Time Frame
24 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: Absolute neutrophil count <1,500 cells/mm3; Platelet count <100,000 cells/mm3; Hemoglobin <9 g/dL; Total bilirubin greater than the upper limit of normal (ULN); AST (SGOT) or ALT (SGPT) >1,5 x ULN; Alkaline phosphatase levels >2,5 x the ULN; Serum creatinine >2,0 mg/dl or 177 umol/l.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilona Kulakiene, Prof.
Organizational Affiliation
Lithuanian University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lithuanian University of Health Sciences
City
Kaunas
ZIP/Postal Code
LT-44307
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
3-7/07/2016 in ASCO (American Society of Clinical Oncology) Annual Meeting, Chicago

Learn more about this trial

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

We'll reach out to this number within 24 hrs