- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02047201
Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC
March 1, 2016 updated by: Ilona Kulakiene, Lithuanian University of Health Sciences
Assessing Tumor Response and IMRT Treatment Planning After Induction Chemotherapy Based on FDG-PET/CT for Locally Advanced Head and Neck Squamous Cell Carcinoma.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaunas, Lithuania, LT-44307
- Lithuanian University of Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
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IMRT treatment planning using FDG-PET/CT images after induction chemotherapy (IC).
Other Names:
Assessing tumor response using FDG-PET/CT.
Other Names:
75 mg/m2, IV (in the vein) on day 1 every 3 weeks.
Number of cycles: 3.
Other Names:
750 mg/m2 continuous infusion for 120 h IV (in the vein) every 3 weeks.
Number of cycles: 3.
Other Names:
75 mg/m2, IV (in the vein) on day 1 every 3 weeks.
Number of cycles: 3.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival (PFS)
Time Frame: 24 months after treatment
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PFS was defined as the time from the first day of IC first cycles to either progression or death.
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24 months after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumour metabolic response (MTV) reduction (%)
Time Frame: 2 weeks after IC
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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.
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2 weeks after IC
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Total lesion glycolysis (TLG) reduction (%)
Time Frame: 2 weeks after IC
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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.
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2 weeks after IC
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SUVmax reductions (%)
Time Frame: 2 weeks after IC
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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.
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2 weeks after IC
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Number (%) of participants with adverse events
Time Frame: 12 and 24 months from chemoradiotherapy
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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.
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12 and 24 months from chemoradiotherapy
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Overall survival (OS)
Time Frame: 24 months after treatment
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OS was defined as the time from the first day of IC first cycles until death from any cause.
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24 months after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ilona Kulakiene, Prof., Lithuanian University of Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
January 22, 2014
First Submitted That Met QC Criteria
January 24, 2014
First Posted (Estimate)
January 28, 2014
Study Record Updates
Last Update Posted (Estimate)
March 2, 2016
Last Update Submitted That Met QC Criteria
March 1, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
- Fluorouracil
Other Study ID Numbers
- EHNCTE-1309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
3-7/07/2016 in ASCO (American Society of Clinical Oncology) Annual Meeting, Chicago
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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