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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02047201
Recruitment Status : Completed
First Posted : January 28, 2014
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Ilona Kulakiene, Lithuanian University of Health Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Radiation: IMRT Radiation: PET/CT Drug: Docetaxel Drug: Fluorouracil Drug: Cisplatin Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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).
 Radiation: IMRT
IMRT treatment planning using FDG-PET/CT images after induction chemotherapy (IC).
Other Name: intensity-modulated radiation therapy

Radiation: PET/CT
Assessing tumor response using FDG-PET/CT.
Other Name: Positron emission tomography-computed tomography

Drug: Docetaxel
75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.
Other Name: Taxotere, Docefrez

Drug: Fluorouracil
750 mg/m2 continuous infusion for 120 h IV (in the vein) every 3 weeks. Number of cycles: 3.
Other Name: 5-Fluorouracil, Adrucil

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047201


Locations
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Lithuania
Lithuanian University of Health Sciences
Kaunas, Lithuania, LT-44307
Sponsors and Collaborators
Lithuanian University of Health Sciences
Investigators
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Principal Investigator: Ilona Kulakiene, Prof. Lithuanian University of Health Sciences
More Information
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Responsible Party: Ilona Kulakiene, Professor, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT02047201    
Other Study ID Numbers: EHNCTE-1309
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 3-7/07/2016 in ASCO (American Society of Clinical Oncology) Annual Meeting, Chicago
Keywords provided by Ilona Kulakiene, Lithuanian University of Health Sciences:
Head and neck cancer
PET/CT
induction chemotherapy
IMRT
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Carcinoma
Carcinoma, Squamous Cell
Docetaxel
Fluorouracil
 Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs