Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma
Primary Purpose
Head and Neck Squamous Carcinoma
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nedaplatin
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Squamous Carcinoma focused on measuring Local advanced head and neck squamous carcinoma, Nedaplatin, Adverse reactions, Efficacy
Eligibility Criteria
Inclusion Criteria:
- voluntarily participated and signed the informed consent form in writing
- is 18-70 and gender unlimited
- histologically proved to be squamous cell carcinoma
- as AJCC(version 8): -A, ⅣB head and neck squamous carcinoma unable or denied surgery; ~ A, ⅣB squamous carcinoma of the head and neck with the following postoperative risk factors: positive or proximal resection, lymph node envelope invasion, nerve and vascular invasion, primary focal pT3 or T4, N2 or N3 lymph node lesions.
- card score ≥ 70
- survival is expected to be ≥ for 6 months
- fertility women should guarantee contraception during entering the study
- Hemoglobin (HGB) ≥ 100 g/L, leukocyte (WBC) ≥ 3.5 × 10^9 / L*(unit normal), Platelet (PLT) ≥ 100 × 10^9 / L(unit normal), neutrophil (WBC) ≥ 1.5 × 10^9 / L*(unit normal)
- liver function: 2.5 times of the upper normal limit (ULN), gluten transaminase (ASAT) <; total bilirubin <1.5 × ULN
- renal function: Serum creatinine <ULN, endogenous creatinine clearance (Ccr) ≥ 55 ml/min
- has no severe complications such as hypertension, diabetes, coronary heart disease, and psychiatric history
- (no history of head and neck radiotherapy or chemotherapy within 3 months)
Exclusion Criteria:
- has a distant transfer
- has received epidermal growth factor targeted or immunotherapy
- has developed other malignant tumors (except for cured basal cell carcinoma or cervical carcinoma in situ)
- pregnant women or lactating women and women of childbearing age who refuse contraception during the treatment observation period
- has a serious history of severe allergies or abnormalities
- refused or cannot sign an informed consent to participate in the trial
- substance abuse or alcohol addicts
Sites / Locations
- The Affiliated Cancer Hospital of Guizhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
the treatment group
the control group
Arm Description
Nedplatin combined with intensive radiotherapy group
Cisplatin was combined with the IMRT group
Outcomes
Primary Outcome Measures
NCI CTCAE 5.0
Acute virulence side response
RESIST1.1
Use to assess recent efficacy
Secondary Outcome Measures
overall survival
Overall survival was assessed at 5 years after the end of chemoradiotherapy during the same period
Progression-free survival rate
Progression-free survival rate was assessed at 5 years after the end of chemoradiotherapy
Full Information
NCT ID
NCT05039606
First Posted
September 1, 2021
Last Updated
September 1, 2021
Sponsor
Guiyang Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05039606
Brief Title
Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma
Official Title
Prospective, Multicentric, Randomized Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guiyang Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was designed as a prospective, multicenter and randomized clinical study of radiotherapy combined with Nedaplatin contrast and cisplatin for local advanced head and neck squamous SCC, aiming to explore the efficacy, safety and long-term efficacy of this trial and control groups and provide some evidence for the selection of clinical treatment options.
Detailed Description
Head and neck squamous cell carcinoma (HNSCC) is a common malignancy accounting for more than 90% of head and neck tumors and over 60% of patients with mid-to late stage (-b) stage at diagnosis.For patients with moderate and advanced head and neck squamous carcinoma, concurrent chemoradiotherapy and chemotherapy is recommended for category 1 and the preferred drug is cisplatin.The application of simultaneous chemoradiotherapy can significantly improve the overall survival rate of patients with locally advanced head and neck squamous carcinoma, and effectively reduce their local recurrence rate and distant metastasis rate.However, the application of cisplatin aggravates the toxic and side reactions, such as nausea and vomiting, radioactive oral mucosal response, nephrotoxicity and ear toxicity.Although the clinical benefit of synchronous chemochemotherapy of locally advanced head and neck squamous carcinoma with cisplatin as chemotherapy is considerable, due to its obvious toxic and side reaction, some patients can not tolerate, cannot complete the whole course of treatment and quality of life, resulting in a substantial reduction in the treatment effect.Therefore, in synchronous chemoradiotherapy of locally advanced head and NSCC, there is an urgent need to find an efficient, hypotoxic, novel chemotherapeutic agent to address this problem.
Nedaplatin is the second generation platinum derivative, for cell cycle nonspecific drugs, mechanism and efficacy similar to cisplatin, anticancer spectrum, and cisplatin without drug resistance, cisplatin resistance still has a good effect, its gastrointestinal reaction and nephrotoxicity is significantly reduced, main dose-limiting toxicity, grade marrow suppression, clinical application without hydration, patients good tolerance and convenient to use, can significantly improve the quality of life of patients.A number of foreign studies have found that nedaplatin combination chemotherapy is effective in esophageal cancer, non-small cell lung cancer and cervical cancer, patients are tolerated, and the digestive tract response is significantly reduced, which helps to ensure the integrity of the course of treatment.Wang Zhennan and other studies reported that nedaplatin can improve the radiosensitivity of NPC CNE-2 cells and show dose-dependent inhibition of tumor cells.Koizumi et al also found that nedaplatin with radiotherapy could effective sensitization.In addition, the results of a phase III randomized controlled trial from the Cancer Center of Sun Yat-sen University, which showed that the overall efficiency of nedaplatin combined radiotherapy for local advanced NPC and 2-year progression-free survival rate were no less than cisplatin (88.7%vs89.7%), and compared with the cisplatin group, gastrointestinal loss, nausea, vomiting and weight loss quality score were significantly improved.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Carcinoma
Keywords
Local advanced head and neck squamous carcinoma, Nedaplatin, Adverse reactions, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the treatment group
Arm Type
Experimental
Arm Description
Nedplatin combined with intensive radiotherapy group
Arm Title
the control group
Arm Type
Active Comparator
Arm Description
Cisplatin was combined with the IMRT group
Intervention Type
Drug
Intervention Name(s)
Nedaplatin
Intervention Description
Nedaplatin is a second-generation platinum-like derivative, which is a cell cycle non-specific drug, with a mechanism of action and efficacy similar to cisplatin, and a wide anti-cancer spectrum
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin, aka cis-dichlorodiamineplatin, is a platinum-containing anticancer drug
Primary Outcome Measure Information:
Title
NCI CTCAE 5.0
Description
Acute virulence side response
Time Frame
1 year
Title
RESIST1.1
Description
Use to assess recent efficacy
Time Frame
1year
Secondary Outcome Measure Information:
Title
overall survival
Description
Overall survival was assessed at 5 years after the end of chemoradiotherapy during the same period
Time Frame
5 years
Title
Progression-free survival rate
Description
Progression-free survival rate was assessed at 5 years after the end of chemoradiotherapy
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
voluntarily participated and signed the informed consent form in writing
is 18-70 and gender unlimited
histologically proved to be squamous cell carcinoma
as AJCC(version 8): -A, ⅣB head and neck squamous carcinoma unable or denied surgery; ~ A, ⅣB squamous carcinoma of the head and neck with the following postoperative risk factors: positive or proximal resection, lymph node envelope invasion, nerve and vascular invasion, primary focal pT3 or T4, N2 or N3 lymph node lesions.
card score ≥ 70
survival is expected to be ≥ for 6 months
fertility women should guarantee contraception during entering the study
Hemoglobin (HGB) ≥ 100 g/L, leukocyte (WBC) ≥ 3.5 × 10^9 / L*(unit normal), Platelet (PLT) ≥ 100 × 10^9 / L(unit normal), neutrophil (WBC) ≥ 1.5 × 10^9 / L*(unit normal)
liver function: 2.5 times of the upper normal limit (ULN), gluten transaminase (ASAT) <; total bilirubin <1.5 × ULN
renal function: Serum creatinine <ULN, endogenous creatinine clearance (Ccr) ≥ 55 ml/min
has no severe complications such as hypertension, diabetes, coronary heart disease, and psychiatric history
(no history of head and neck radiotherapy or chemotherapy within 3 months)
Exclusion Criteria:
has a distant transfer
has received epidermal growth factor targeted or immunotherapy
has developed other malignant tumors (except for cured basal cell carcinoma or cervical carcinoma in situ)
pregnant women or lactating women and women of childbearing age who refuse contraception during the treatment observation period
has a serious history of severe allergies or abnormalities
refused or cannot sign an informed consent to participate in the trial
substance abuse or alcohol addicts
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Jin, Bachelor
Phone
86-851-86512802
Email
jinf8865@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Wu, Master
Phone
86-13885124077
Email
wwlmhy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Jin, Bachelor
Organizational Affiliation
The Affiliated Cancer Hospital of Guizhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The Affiliated Cancer Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Jin, Bachelor
Phone
86-13985124806
Email
jinf8865@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Weili Wu, Master
Phone
86-13885124077
Email
wwlmhy@163.com
First Name & Middle Initial & Last Name & Degree
Weili Wu, master
First Name & Middle Initial & Last Name & Degree
Yuanyuan Li, master
First Name & Middle Initial & Last Name & Degree
Jinhua Long, master
First Name & Middle Initial & Last Name & Degree
Xiuyun Gong, bachelor
First Name & Middle Initial & Last Name & Degree
Xiaoxiao Chen, bachelor
First Name & Middle Initial & Last Name & Degree
Mang Zhang, master
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma
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