Carcinoma, Squamous Cell of Head and NeckPhase 2NCT02753140
Concurrent Chemoradiotherapy(CRT) in Locally Advanced(LA) SCCHN vs Cetuximab With Radiotherapy (RT) After Neoadjuvant Chemotherapy
A Phase 2 study testing Cetuximab, radiation and Docetaxel in people with Carcinoma, Squamous Cell of Head and Neck, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Trial summary
Verify the effect and the incidence of oral mucositis of concurrent chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell of Head and Neck
- What is being tested?
- Cetuximab, radiation and Docetaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed first diagnosis of locally advanced squamous cell carcinoma of the head and neck
- Imaging (MRI, CT, bone scan) stage Ⅲ、Ⅳa (T1-2N2M0、T3N0-2M0、T4N0-2M0) (2010AJCC staging criteria)
- 18 years of age or older
- Presence of at least 1 measurable lesion according to RECIST version1.1
- DON'T accept surgery, chemotherapy or irradiation before trial entry
- Eastern Cooperative Oncology Group(ECOG) 0 or 1
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- Expected survival period over 6months
- Before RT randomization, bone marrow and liver and kidney function in patients with meet the following criteria:
- Hemoglobin(HB) ≥ 100g/L, neutrophil ≥ 2.0 × 109/L and platelet ≥ 100 × 109/L
- Total bilirubin ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal;
- More than 1.5 times the upper limit of normal serum creatinine or creatinine clearance rate ≥ 60 ml/min, urea N ≤ 200mg/L;
- The blood glucose level: good blood glucose control, fasting glucose, 3.9-7.2mmol/L postprandial blood glucose less than 10.0mmol/L, HbA1c < 7%;
- Signed written informed consent before any trail-related activities are carried out.
Who cannot join
- Patients accepted chemotherapy、radiotherapy or surgery;
- Distant metastasis before trail entry
- Female subjects who are pregnant or breast feeding;
- oral mucositis or oral mucositis has repeatedly made (1 times / month or more)before Chemotherapy or radiotherapy ;
- With teeth periodontitis;
- Any investigational medication within 30 days before trial entry;
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- Elderly patients with dry stomatitis;
- Any unstable system diseases: including active infection, uncontrolled hypertension, unstable angina pectoris, within the last 3 months of the onset of angina, congestive heart failure, the group in June before the myocardial infarction, need serious mental disorder drug treatment, liver, kidney or metabolic diseases; mental / spiritual diseases such as Alzheimer's disease;
- Total bilirubin > 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 times the upper limit of normal;
- On gastrointestinal physiology is not perfect, or absorb the obstacle syndrome, or unable to tolerate oral medication, or active peptic ulcer；
- Past or current history of neoplasm oher than squamous cell carcinoma of the head and neck;
- Judgment according to the researchers, there are serious harm to patient safety or affect the patients completed the study with the disease, and patient compliance with the difference;
- known human immunodeficiency virus (HIV) infection;
- With immunodeficiency disease, or suffer from other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
- Any disease, metabolic disorders, or physical examination or laboratory suspicion or treatment of complications in patients at high risk of drug.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck Versus Concomitant Cetuximab With Radiotherapy After Neoadjuvant Chemotherapy: a Randomized, Opened, Multicenter Phase II Trial
Verify the effect and the incidence of oral mucositis of concurrent chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy.
The predictive effect of Apurinic/apyrimidinic endonuclease 1(APE1)/ Ref-1 protein and Apurinic/apyrimidinic endonuclease 1(APE1)/Ref-1 antibody on oral mucositis.
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RT concurrent with cetuximab | Experimental | Selected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy.To observe the curative effect of the treatment of the cetuximab Receives: Drug: Cetuximab; Radiation: radiation |
| RT concurrent with TP | Experimental | Selected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy. To observe the curative effect of concurrent radiotherapy and chemotherapy Receives: Radiation: radiation; Drug: Docetaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 13 months
incidence of oral mucositis
Measured: 3 months
Secondary outcomes (2)
Overall survival
Measured: 5 years
Overall response rate after induction chemotherapy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous Cell of Head and NeckStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-zhou Yang, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753140
- Sponsor's protocol ID
- YangZZ-2016
- Status last verified
- Apr 2016
- First submitted
- 18 Apr 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck Versus Concomitant Cetuximab With Radiotherapy After Neoadjuvant Chemotherapy: a Randomized, Opened, Multicenter Phase II Trial
- ClinicalTrials.gov ID
- NCT02753140
- Acronym / sponsor ID
- YangZZ-2016
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Apr 2016 (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.
Verify the effect and the incidence of oral mucositis of concurrent chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy.
The predictive effect of Apurinic/apyrimidinic endonuclease 1(APE1)/ Ref-1 protein and Apurinic/apyrimidinic endonuclease 1(APE1)/Ref-1 antibody on oral mucositis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT concurrent with cetuximab | Experimental | Drug: Cetuximab, Radiation: radiationSelected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy.To observe the curative effect of the treatment of the cetuximab |
| RT concurrent with TP | Experimental | Radiation: radiation, Drug: Docetaxel, Drug: CisplatinSelected 60 patients with locally advanced squamous cell carcinoma of the head and neck. They will be randomized to concurrent chemoradiotherapy versus concomitant cetuximab with radiotherapy after neoadjuvant chemotherapy. To observe the curative effect of concurrent radiotherapy and chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically confirmed first diagnosis of locally advanced squamous cell carcinoma of the head and neck
- Imaging (MRI, CT, bone scan) stage Ⅲ、Ⅳa (T1-2N2M0、T3N0-2M0、T4N0-2M0) (2010AJCC staging criteria)
- 18 years of age or older
- Presence of at least 1 measurable lesion according to RECIST version1.1
- DON'T accept surgery, chemotherapy or irradiation before trial entry
Key exclusion criteria (15 listed)
- Patients accepted chemotherapy、radiotherapy or surgery;
- Distant metastasis before trail entry
- Female subjects who are pregnant or breast feeding;
- oral mucositis or oral mucositis has repeatedly made (1 times / month or more)before Chemotherapy or radiotherapy ;
- With teeth periodontitis;
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 |
|---|---|---|
| Cetuximab | Drug | RT concurrent with cetuximab |
| radiation | Radiation | RT concurrent with TP, RT concurrent with cetuximab |
| Docetaxel | Drug | RT concurrent with TP |
| Cisplatin | Drug | RT concurrent with TP |
Primary outcome
Progression-free survival
Time frame: 13 months
incidence of oral mucositis
Time frame: 3 months
2 secondary outcomes
Overall survival
Time frame: 5 years
Overall response rate after induction chemotherapy
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab, radiation and Docetaxel in people with Carcinoma, Squamous Cell of Head and Neck, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
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 13 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhou Yang, Doctor (+86-13883270881, yangzz1970@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 13 months). The study lists 2 primary outcomes in all. 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 27 Apr 2016.