Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 2NCT03196869
the Study of Effect of Chronomodulated Chemotherapy on the Dendritic Cells Subsets in the Treatment of Advanced Nasopharyngeal Cancer
A Phase 2 study testing Chrono-chemotherapy, Routine intravenous drip and induction Chrono-chemotherapy in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Guiyang Medical University at 1 site in China.
Trial summary
This study is to observe and compare the effect of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy on dendritic cells subsets in the treatment of locally advanced head and neck squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Chrono-chemotherapy, Routine intravenous drip and induction Chrono-chemotherapy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2017to 12 Aug 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- initial treatment of advanced nasopharyngeal carcinoma Ⅲ-Ⅳ patients with pathologically confirmed (according to 2010 UICC staging, T3-4, N0-3), without evidence of distant metastasis (M0). Have measurable tumor lesions.
- KPS≥70 points.
- the age of 18-70 years old, male or female.
- no major organ dysfunction; normal bone marrow function (WBC ≥4.0 × 109 / L, platelets ≥100 × 109 / L, hemoglobin ≥90g / L), normal liver function (total bilirubin, alanine aminotransferase, aspartate aminotransferase ≤1.5 times the upper limit of normal), normal renal function (creatinine ≤ 1.5 times upper limit of normal).
- understand this study and signed informed consent
Who cannot join
- Three months in the use of Chinese herbal medicine or immune modulators
- distant metastasis.
- who had received prior chemotherapy.
- patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications.
- pregnancy (via the urine or serum β-HCG test confirmed) or during lactation. serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
Feng Jin, Bachelor, 0851-86512802, jinf8865@yahoo.com.cn
Weili Wu, master
About this study
Official title: Phase II Clinical Randomized Study of the Effect of Chronomodulated Chemotherapy Followed by Concurrent IMRT Chemo-radiotherapy on the Dendritic Cells Subsets and Immunity in the Treatment of Advanced Nasopharyngeal Cancer
This study is to observe and compare the effect of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy on dendritic cells subsets in the treatment of locally advanced head and neck squamous cell carcinoma.
Read the detailed description
TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy.Dendritic cells (DC) play an essential role in the induction and regulation of immune responses.The effect of radiation and chemotherapy is closely related to the patients' immune function.In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed the relationship between dendritic cells subsets and clinical prognosis of patients, to provide a new method for the treatment of locally advanced nasopharyngeal carcinoma and technical support
- Being tested
- Chrono-chemotherapy, Routine intravenous drip, induction Chrono-chemotherapy, induction Routine-chemotherapy, cisplatin chrono-chemotherapy
- Keywords
- NPC peripheral blood dendritic cell chronic-chemotherap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chrono-chemotherapyDevice
Also called Experimental group
Chrono-chemotherapy+concurrent radiochemotherapy
Routine intravenous dripDevice
Also called control group
Routine intravenous drip-chemotherap
induction Chrono-chemotherapyDrug
Also called chronological dosage
Experimental group:docetaxel,cisplatin,5-FU
induction Routine-chemotherapyDrug
Also called Conventional drug delivery
control group:docetaxel,cisplatin,5-FU
cisplatin chrono-chemotherapyDrug
Also called cisplatin Conventional drug delivery
Experimental group: cisplatin chrono-chemotherapy
cisplatin routine-chemotherapyDrug
Also called cisplatin Conventional drug delivery
control group:cisplatin routine-chemotherapy
intensity-modulated radiation therapyRadiation
control group is similar to Experimental group
| Study group | Role | What they receive |
|---|---|---|
| Chrono-chemotherapy group | Experimental | Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group Receives: Device: Chrono-chemotherapy; Drug: induction Chrono-chemotherapy; Drug: cisplatin chrono-chemotherapy; Radiation: intensity-modulated radiation therapy |
| Routine intravenous drip | Other | control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy Receives: Device: Routine intravenous drip; Drug: induction Routine-chemotherapy; Drug: cisplatin routine-chemotherapy; Radiation: intensity-modulated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dendritic cell subgroup changes of Participants
By flow cytometry detection of two groups of peripheral blood dendritic cells subsets and lymphocyte subpopulation changes before and after the radiation and chemotherapy
Measured: termination of treatment, 3 months after treatment
Secondary outcomes (2)
Number of Participants with curative effect
Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST
Measured: 1 year
Number of Participants with Adverse Events as a Measure of Safety
To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 4.0
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start7 Apr 2017
- Primary completion12 Apr 2019 (estimated)
- Study completion12 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guiyang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Jing, Guiyang Medical University
- Investigators
- Feng Jin, Bachelor, Study chair, Guizhou Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196869
- Sponsor's protocol ID
- 201708112121
- Status last verified
- Jun 2017
- First submitted
- 21 Jun 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Randomized Study of the Effect of Chronomodulated Chemotherapy Followed by Concurrent IMRT Chemo-radiotherapy on the Dendritic Cells Subsets and Immunity in the Treatment of Advanced Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT03196869
- Acronym / sponsor ID
- 201708112121
- Keywords
- NPC peripheral blood dendritic cell chronic-chemotherap
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Guiyang Medical UniversityUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 12 Apr 2019 (estimated)
- Study completion
- 12 Aug 2022 (estimated)
- First posted
- 23 Jun 2017 (actual)
- 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.
This study is to observe and compare the effect of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy on dendritic cells subsets in the treatment of locally advanced head and neck squamous cell carcinoma.
Detailed description
TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy.Dendritic cells (DC) play an essential role in the induction and regulation of immune responses.The effect of radiation and chemotherapy is closely related to the patients' immune function.In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed the relationship between dendritic cells subsets and clinical prognosis of patients, to provide a new method for the treatment of locally advanced nasopharyngeal carcinoma and technical support
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chrono-chemotherapy group | Experimental | Device: Chrono-chemotherapy, Drug: induction Chrono-chemotherapy, Drug: cisplatin chrono-chemotherapy, Radiation: intensity-modulated radiation therapyInduction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group |
| Routine intravenous drip | Other | Device: Routine intravenous drip, Drug: induction Routine-chemotherapy, Drug: cisplatin routine-chemotherapy, Radiation: intensity-modulated radiation therapycontrol group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- initial treatment of advanced nasopharyngeal carcinoma Ⅲ-Ⅳ patients with pathologically confirmed (according to 2010 UICC staging, T3-4, N0-3), without evidence of distant metastasis (M0). Have measurable tumor lesions.
- KPS≥70 points.
- the age of 18-70 years old, male or female.
- no major organ dysfunction; normal bone marrow function (WBC ≥4.0 × 109 / L, platelets ≥100 × 109 / L, hemoglobin ≥90g / L), normal liver function (total bilirubin, alanine aminotransferase, aspartate aminotransferase ≤1.5 times the upper limit of normal), normal renal function (creatinine ≤ 1.5 times upper limit of normal).
- understand this study and signed informed consent
Key exclusion criteria (5 listed)
- Three months in the use of Chinese herbal medicine or immune modulators
- distant metastasis.
- who had received prior chemotherapy.
- patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications.
- pregnancy (via the urine or serum β-HCG test confirmed) or during lactation. serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.
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 |
|---|---|---|
| Chrono-chemotherapyAlso: Experimental groupChrono-chemotherapy+concurrent radiochemotherapy | Device | Chrono-chemotherapy group |
| Routine intravenous dripAlso: control groupRoutine intravenous drip-chemotherap | Device | Routine intravenous drip |
| induction Chrono-chemotherapyAlso: chronological dosageExperimental group:docetaxel,cisplatin,5-FU | Drug | Chrono-chemotherapy group |
| induction Routine-chemotherapyAlso: Conventional drug deliverycontrol group:docetaxel,cisplatin,5-FU | Drug | Routine intravenous drip |
| cisplatin chrono-chemotherapyAlso: cisplatin Conventional drug deliveryExperimental group: cisplatin chrono-chemotherapy | Drug | Chrono-chemotherapy group |
| cisplatin routine-chemotherapyAlso: cisplatin Conventional drug deliverycontrol group:cisplatin routine-chemotherapy | Drug | Routine intravenous drip |
| intensity-modulated radiation therapycontrol group is similar to Experimental group | Radiation | Chrono-chemotherapy group, Routine intravenous drip |
Primary outcome
Dendritic cell subgroup changes of Participants
Time frame: termination of treatment, 3 months after treatment
By flow cytometry detection of two groups of peripheral blood dendritic cells subsets and lymphocyte subpopulation changes before and after the radiation and chemotherapy
2 secondary outcomes
Number of Participants with curative effect
Time frame: 1 year
Number of Participants with Adverse Events as a Measure of Safety
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Feng Jin, Bachelor study chair
Guizhou Provincial Cancer Hospital
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 Chrono-chemotherapy, Routine intravenous drip and induction Chrono-chemotherapy in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Guiyang Medical University at 1 site in China.
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 5 inclusion and 5 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 23 Jun 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Jin, Bachelor (0851-86512802, jinf8865@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dendritic cell subgroup changes of Participants (time frame: termination of treatment, 3 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 23 Jun 2017.