Nedaplatin in Treatment for Nasopharyngeal Carcinoma

NCT ID: NCT04834206

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-05-01

Brief Summary

To evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma.

Detailed Description

This is a prospective, phase II clinical trial to evaluate the efficacy and safety of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma patients. This is a multicenter study. All patients will be enrolled in endemic area. All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is objective response rate (ORR).

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DNF-N

1. Induction chemotherapy:

three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks

2. Concurrent chemoradiotherapy:

three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy

3. Radiotherapy: radical intense modulated radiation therapy

Group Type: OTHER

Docetaxel, nedaplatin, fluorouracil

Intervention Type: DRUG

Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.

IMRT

Intervention Type: RADIATION

Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.

Nedaplatin

Intervention Type: DRUG

Concurrent chemotherapy. nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.

Interventions

Docetaxel, nedaplatin, fluorouracil

Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.

Intervention Type: DRUG

IMRT

Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.

Intervention Type: RADIATION

Nedaplatin

Concurrent chemotherapy. nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.

Intervention Type: DRUG

Other Intervention Names

DNF; RT; N

Eligibility Criteria

Inclusion Criteria

• Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
• Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system
• No evidence of distant metastasis (M0)
• Age between 18-65
• WBC≥4×10^9/ l, platelet ≥ 100×10^9/ l and hemoglobin ≥ 90g/l
• With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)
• With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min)
• Satisfactory performance status: KARNOFSKY scale (KPS) > 70
• Patients must give signed informed consent

Exclusion Criteria

• Treatment with palliative intent
• The primary tumor or lymph node has undergone chemotherapy or surgery (except operations for diagnostic purposes)
• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
• History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes
• History of previous radiotherapy
• Pregnancy or lactation
• Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, active hepatitis, and mental disturbance.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jin-Quan Liu

Section Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinquan Liu, M.D

Role: STUDY_DIRECTOR

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Locations

Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical Universityedical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

NPC-NDP-SGL arm

Identifier Type: -

Identifier Source: org_study_id