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

NCT04766827 | Unknown Phase 4

• 1 other identifier: TJCIHMF&ENT-001
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  ORR=CR+PR

  21 days

Secondary Outcomes (4)

• Surgical resection rate

  1 month

• pathological response rate

  1 month

• PFS

  5 year

• OS

  5 year

Other Outcomes (1)

• Incidence of adverse events

  90 days

Study Arms (2)

albumin-bound paclitaxel combined with cisplatin (AP regimen)

EXPERIMENTAL

Paclitaxel (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;

Drug: albumin-bound paclitaxel

docetaxel combined with cisplatin (TP regimen)

ACTIVE COMPARATOR

docetaxel: 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;

Drug: albumin-bound paclitaxel

Interventions

albumin-bound paclitaxel DRUG

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.

Also known as: Docetaxel

albumin-bound paclitaxel combined with cisplatin (AP regimen); docetaxel combined with cisplatin (TP regimen)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• Abnormal results of physical and laboratory tests:
• A) Hematologic abnormalities are defined as:
• I) Absolute count of neutrophils (ANC) : \< 1.5×109 / L; Ii) Platelet (PLT) count: \< 100×109/L; Iii) Hemoglobin (Hb) level \< 90g/L;
• B) Abnormal liver function is defined as:
• I) 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;
• C) Definition of abnormal renal function:
• 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;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Albumin-Bound Paclitaxel; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Xudong Wang, MD

  Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center of Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xudong Wang, MD

CONTACT

022-23340123; wxd.1130@163.com

Ze Zhang, MD

CONTACT

022-23340123; zhangze@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective randomized controlled clinical trail

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 23, 2021
• Study Start: December 12, 2020
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 23, 2021

Record last verified: 2020-11

Locations

CN (1)