Head and Neck Squamous Cell CarcinomaPhase 2NCT02047201
Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC
A Phase 2 study testing IMRT, PET/CT and Docetaxel in people with Head and Neck Squamous Cell Carcinoma, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- IMRT, PET/CT and Docetaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteLithuania
- Study dates
- Jun 2013to Jan 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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; ;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- IMRT, PET/CT, Docetaxel, Fluorouracil, Cisplatin
- Keywords
- Head and neck cancer, PET/CT, induction chemotherapy, IMRT
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRTRadiation
Also called intensity-modulated radiation therapy
IMRT treatment planning using FDG-PET/CT images after induction chemotherapy (IC).
PET/CTRadiation
Also called Positron emission tomography-computed tomography
Assessing tumor response using FDG-PET/CT.
DocetaxelDrug
Also called Taxotere, Docefrez
75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.
FluorouracilDrug
Also called 5-Fluorouracil, Adrucil
750 mg/m2 continuous infusion for 120 h IV (in the vein) every 3 weeks. Number of cycles: 3.
CisplatinDrug
Also called Platinol
75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Radiation: IMRT; Radiation: PET/CT; Drug: Docetaxel; Drug: Fluorouracil; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS was defined as the time from the first day of IC first cycles to either progression or death.
Measured: 24 months after treatment
Secondary outcomes (5)
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.
Measured: 2 weeks after IC
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.
Measured: 2 weeks after IC
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.
Measured: 2 weeks after IC
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.
Measured: 12 and 24 months from chemoradiotherapy
Overall survival (OS)
OS was defined as the time from the first day of IC first cycles until death from any cause.
Measured: 24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilona Kulakiene, Lithuanian University of Health Sciences
- Investigators
- Ilona Kulakiene, Prof., Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047201
- Sponsor's protocol ID
- EHNCTE-1309
- Status last verified
- Mar 2016
- First submitted
- 22 Jan 2014
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 3-7/07/2016 in ASCO (American Society of Clinical Oncology) Annual Meeting, Chicago
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02047201
- Acronym / sponsor ID
- EHNCTE-1309
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and neck cancer, PET/CT, induction chemotherapy, IMRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Radiation: IMRT, Radiation: PET/CT, Drug: Docetaxel, Drug: Fluorouracil, Drug: CisplatinInduction chemotherapy (Docetaxel, Cisplatin and Fluorouracil) following radiochemotherapy (IMRT using PET/CT images after IC for treatment planning + cisplatin iv 40 mg/m2 weekly). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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);
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMRTAlso: intensity-modulated radiation therapyIMRT treatment planning using FDG-PET/CT images after induction chemotherapy (IC). | Radiation | Experimental |
| PET/CTAlso: Positron emission tomography-computed tomographyAssessing tumor response using FDG-PET/CT. | Radiation | Experimental |
| DocetaxelAlso: Taxotere, Docefrez75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3. | Drug | Experimental |
| FluorouracilAlso: 5-Fluorouracil, Adrucil750 mg/m2 continuous infusion for 120 h IV (in the vein) every 3 weeks. Number of cycles: 3. | Drug | Experimental |
| CisplatinAlso: Platinol75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3. | Drug | Experimental |
Primary outcome
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.
5 secondary outcomes
Tumour metabolic response (MTV) reduction (%)
Time frame: 2 weeks after IC
Total lesion glycolysis (TLG) reduction (%)
Time frame: 2 weeks after IC
SUVmax reductions (%)
Time frame: 2 weeks after IC
Number (%) of participants with adverse events
Time frame: 12 and 24 months from chemoradiotherapy
Overall survival (OS)
Time frame: 24 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Individual participant dataSharing planned: Yes. 3-7/07/2016 in ASCO (American Society of Clinical Oncology) Annual Meeting, Chicago
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilona Kulakiene, Prof. principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMRT, PET/CT and Docetaxel in people with Head and Neck Squamous Cell Carcinoma, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 24 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.