Clinical trial NCT04834206: Nedaplatin in Treatment for Nasopharyngeal Carcinoma
Official title: Induction Chemotherapy With Nedaplatin, Docetaxel and 5-Fluorouracil Followed by Concurrent Nedaplatin and Radiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Single Arm, Open Label, Multicenter, Phase II Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Induction chemotherapy
Nedaplatin
Concurrent chemoradiotherapy
Nasopharyngeal Carcinoma
Lead sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: objective response rate (ORR)
timeFrame: at the end of radiotherapy(±1week）
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: 3 years
measure: Progress-Free Survival (PFS)
timeFrame: 3 years
measure: Locoregional Relapse-Free Survival(LRRFS)
timeFrame: 3 years
measure: Distant metastasis-Free Survival(DMFS)
timeFrame: 3 years
measure: Quality of life (QoL)
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical Universityedical University
state: Guangdong
Study officials:
affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Jinquan Liu, M.D
role: STUDY_DIRECTOR
References: