Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma

Prospective, Multicentric, Randomized Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Squamous Carcinoma
• Intervention / Treatment: Drug: Nedaplatin; Drug: Cisplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 164
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550000
      • The Affiliated Cancer Hospital of Guizhou Medical University
      • Contact: Feng Jin, Bachelor; Phone Number: 86-13985124806; Email: jinf8865@yahoo.com.cn
      • Sub-Investigator: Mang Zhang, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. voluntarily participated and signed the informed consent form in writing
2. is 18-70 and gender unlimited
3. histologically proved to be squamous cell carcinoma
4. 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.
5. card score ≥ 70
6. survival is expected to be ≥ for 6 months
7. fertility women should guarantee contraception during entering the study
8. 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)
9. liver function: 2.5 times of the upper normal limit (ULN), gluten transaminase (ASAT) <; total bilirubin <1.5 × ULN
10. renal function: Serum creatinine <ULN, endogenous creatinine clearance (Ccr) ≥ 55 ml/min
11. has no severe complications such as hypertension, diabetes, coronary heart disease, and psychiatric history
12. (no history of head and neck radiotherapy or chemotherapy within 3 months)

Exclusion Criteria:

1. has a distant transfer
2. has received epidermal growth factor targeted or immunotherapy
3. has developed other malignant tumors (except for cured basal cell carcinoma or cervical carcinoma in situ)
4. pregnant women or lactating women and women of childbearing age who refuse contraception during the treatment observation period
5. has a serious history of severe allergies or abnormalities
6. refused or cannot sign an informed consent to participate in the trial
7. substance abuse or alcohol addicts

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the treatment group; Nedplatin combined with intensive radiotherapy group	Drug: Nedaplatin; 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
Active Comparator: the control group; Cisplatin was combined with the IMRT group	Drug: Cisplatin; Cisplatin, aka cis-dichlorodiamineplatin, is a platinum-containing anticancer drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NCI CTCAE 5.0	Acute virulence side response	1 year
RESIST1.1	Use to assess recent efficacy	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	Overall survival was assessed at 5 years after the end of chemoradiotherapy during the same period	5 years
Progression-free survival rate	Progression-free survival rate was assessed at 5 years after the end of chemoradiotherapy	5 years

Collaborators and Investigators

• Sponsor: Guiyang Medical University
• Investigators: Study Chair: Feng Jin, Bachelor, The Affiliated Cancer Hospital of Guizhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): September 1, 2026
• Study Completion (Anticipated): September 1, 2026

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Efficacy; Local advanced head and neck squamous carcinoma; Nedaplatin; Adverse reactions
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Antineoplastic Agents; Nedaplatin
• Other Study ID Numbers: 20210829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No