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Squamous Cell Carcinoma of Head and NeckPhase 4NCT04766827

Albumin-bound Paclitaxel Combined With Cisplatin Versus Docetaxel Combined With Cisplatin Induced Chemotherapy in Advanced Head and Neck Squamous Tummor

A Phase 4 study testing albumin-bound paclitaxel in people with Squamous Cell Carcinoma of Head and Neck, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Research Topic: A prospective randomized controlled clinical study of albumin-bound paclitaxel combined with cisplatin (AP regimen) versus docetaxel combined with cisplatin (TP regimen) induced chemotherapy in advanced head and neck squamous cell carcinoma Expected study duration: Each subject received a 3-week… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma of Head and Neck
What is being tested?
albumin-bound paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteChina
Study dates
12 Dec 2020to Dec 2021
Phase
Phase 4
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

  • Age ≥18 years old, male or female;
  • Subjects had squamous cell carcinoma of the head and neck confirmed by histrohistology or cytology;
  • CLINICAL STAGE III OR IV WITHOUT DISTANT METASTASES (AJCC 8th)
  • Patients who have not previously received initial treatment with chemotherapy or radiation;
  • KPS acuity 70;
  • Normal bone marrow reserve function and normal liver and kidney function;
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  • Expected survival time ≥3 months;
  • Subjects of child-bearing age must agree to use effective contraceptive measures during the study period; The serum or urine pregnancy test must be negative for women of childbearing age 72 hours before the start of chemotherapy;
  • Subjects have good compliance, can carry out treatment and follow-up, and voluntarily abide by the regulations of this study;
  • Subjects voluntarily sign the informed consent.

Who cannot join

  • Patients with distant metastasis;
  • The presence of uncontrolled serious medical diseases, such as combined with serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
  • The presence of dementia, altered mental status or any mental illness that would prevent understanding or giving informed consent or filling out questionnaires;
  • Subjects with grade ≥2 peripheral neuropathy according to CTCAE V5.0;
  • A history of allergy or hypersensitivity to any therapeutic ingredient;
  • Suffered from malignant tumors other than squamous cell carcinoma of the head and neck in the past 5 years, except adequately treated basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
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  • Abnormal results of physical and laboratory tests:
  • Hematologic abnormalities are defined as:
  • Absolute count of neutrophils (ANC) : < 1.5×109 / L; Ii) Platelet (PLT) count: < 100×109/L; Iii) Hemoglobin (Hb) level < 90g/L;
  • Abnormal liver function is defined as:
  • Total bilirubin (TBIL) level: 1.5 times of the upper limit of normal value of > (ULN); Ii) AST and ALT levels of >ULN were 2.5 times, and BBB>N was 5 times if liver metastasis was present;
  • Definition of abnormal renal function:
  • 1.5 times of serum creatinine > ULN, or the calculated creatinine clearance rate < 50ml/min;
  • Patients who need to be treated with other anti-tumor drugs;
  • Has received any other investigational drug therapy or participated in another interventional clinical trial within 30 days prior to screening;
  • The researcher considers it unsuitable for inclusion;
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

Xudong Wang, MD contact

022-23340123 ext. 3130

wxd.1130@163.com

Ze Zhang, MD contact

022-23340123 ext. 3130

zhangze@tmu.edu.cn

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300000

    Hongling wang, MD, +86 022 23340123 ext. 3130, wanghongling86@163.com

    Ze Zhang, MD, +86 022 23340123 ext. 3130, zhangze_smu@163.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective Randomized Controlled Clinical Study of Albumin-bound Paclitaxel Combined With Cisplatin (AP Regimen) Versus Docetaxel Combined With Cisplatin (TP Regimen) Induced Chemotherapy in Advanced Head and Neck Squamous Tummor

Research Topic:

A prospective randomized controlled clinical study of albumin-bound paclitaxel combined with cisplatin (AP regimen) versus docetaxel combined with cisplatin (TP regimen) induced chemotherapy in advanced head and neck squamous cell carcinoma

Read more

Expected study duration:

Each subject received a 3-week regimen of AP or TP over 2 cycles.

Research objectives:

To evaluate the efficacy and safety of induction chemotherapy with albumin-bound paclitaxel in patients with advanced head and neck squamous cell carcinoma (HSCC), two induction chemotherapy regimens, AP regimen and TP regimen, were compared.

Trial Design. Single center, open label, controlled clinical study Number of cases: 116 Objective response rate (ORR=CR+PR) was used as the main evaluation index in this study.

Read the detailed description

Research purposes:Research the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma were evaluated,by comparing the AP regimen and the TP regimen .

Research content:To evaluate the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma.

Study endpoint Primary endpoint: Objective response rate (ORR=CR+PR) (Assessed according to RECIST standards, see Annex 1) Secondary study endpoint: Surgical resection rate,Pathological remission rate,Progression-free survival (PFS), Overall survival (OS) Main safety indicators: Observe any adverse events that occurred in all subjects during the clinical study and within 1 month after stopping the drug, including clinical symptoms, abnormal vital signs, and abnormalities in laboratory examinations, and record their clinical features, Severity, time of occurrence, duration, treatment method and prognosis outcome, and determine its correlation with the study drug. The safety of the drug was evaluated according to the NCI-CTC AE 4.0 standard.

Study design:This is a single-center, open-label, controlled clinical study.The aime is observing and evaluating the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma.

This study is planned to be carried out in Tianjin Cancer Hospital. According to the research principles of GCP.

The study plans to recruit 116 qualified subjects. This study used objective response rate (ORR=CR+PR) as the main evaluation index. According to previous reports, the ORR of the TP group was 50%, and the ORR of the AP group was estimated to be 75%. The test level is set to 0.05 on one side, the test power is set to 0.8, and the estimated dropout rate is 20%. Using the Logrank-Lakatos algorithm, the total sample size is calculated to be 116 cases.

Being tested
albumin-bound paclitaxel
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.

  • albumin-bound paclitaxelDrug

    Also called Docetaxel

    Paclitaxel for injection (albumin-bound) uses human serum albumin as the carrier to avoid the use of organic solvents for intravenous injection of paclitaxel, reducing the incidence of allergic reactions, and reducing the toxicity of the drug.

Study groups in NCT04766827
Study groupRoleWhat they receive
albumin-bound paclitaxel combined with cisplatin (AP regimen)ExperimentalPaclitaxel (albumin combined type) 260 mg/m2, intravenous drip, d1, every three weeks for a cycle, a total of dosing 2 cycles; Cisplatin: 75 mg/m2, intravenous drip, d1, every three weeks for a cycle, a total of dosing 2 cycles;
Receives: Drug: albumin-bound paclitaxel
docetaxel combined with cisplatin (TP regimen)Active comparatordocetaxel: 75 mg/m2, intravenous drip, d1, every three weeks for a cycle, a total of dosing 2 cycles; cisplatin: 75 mg/m2, d1 every three weeks for a cycle, a total of dosing 2 cycles;
Receives: Drug: albumin-bound paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    ORR=CR+PR

    Measured: 21 days

Secondary outcomes (4)

  1. Surgical resection rate

    the rate of Surgical resection in all samples

    Measured: 1 month

  2. pathological response rate

    the rate of pathological response in all samples

    Measured: 1 month

  3. PFS

    progression-free survival

    Measured: 5 year

  4. OS

    overall survival

    Measured: 5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2021
  2. Study start12 Dec 2020
  3. Primary completionNov 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective randomized controlled clinical trail
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04766827
Sponsor's protocol ID
TJCIHMF&ENT-001
Status last verified
Nov 2020
First submitted
29 Jan 2021
Last updated
23 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing albumin-bound paclitaxel in people with Squamous Cell Carcinoma of Head and Neck, run by Tianjin Medical University Cancer Institute and Hospital 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 10 inclusion and 17 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 Feb 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Xudong Wang, MD (022-23340123 ext. 3130, wxd.1130@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04766827.

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 Feb 2021.

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