Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma

Sun Yat-sen University402 enrolled

Overview

This is a Phase III trial to study the effectiveness of nedaplatin versus cisplatin with IMRT chemoradiotherapy in treating patients with locoregionally advanced nasopharyngeal carcinoma.

Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced NPC. Cisplatin-based chemotherapy has been shown to have higher response rates in NPC than noncisplatin regimens. However, the patients' compliance was unsatisfactory because the obvious gastrointestinal toxicity of cisplatin. Nedaplatin is the new second generation platinum and it has slight gastrointestinal reaction. Our trial is in order to study the effectiveness of nedaplatin or cisplatin with intensity-modulated radiation therapy (IMRT) chemoradiotherapy in treating patients with locoregionally advanced NPC.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

402

Conditions

Nasopharyngeal Carcinoma

Interventions

NedaplatinDRUG

Nedaplatin 100mg/m2(3 weekly),D1,D22,D43 of RT

CisplatinDRUG

Cisplatin 100mg/m2(3 weekly),D1,D22,D43 of RT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III * Original clinical staged as T1-4N1-3 or T3-4N0（according to the 7th AJCC edition） * No evidence of distant metastasis (M0) * Male and no pregnant female * Age between 18-65 * WBC ≥ 4,000/mm3 and PLT ≥ 100,000/mm3 * With normal liver function test (ALT、AST ≤ 2.5×ULN) * With normal renal function test (Creatinine ≤ 1.5×ULN) * Satisfactory performance status: Karnofsky scale (KPS)\> 70 * Without radiotherapy or chemotherapy * Patients must give signed informed consent Exclusion Criteria: * Patients have evidence of relapse or distant metastasis * The presence of uncontrolled life-threatening illness * Receiving other ways of anti-cancer therapy * Receiving radiotherapy or chemotherapy * Pregnancy or lactation

Locations (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Progress-free survival

Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

Time frame: 2 years

Secondary Outcomes

Determine the toxic effects, both quantitatively and qualitatively, and quality of life (QoL) of these regimens in these patients.

Administration and Monitoring Patients will be evaluated in the clinic and eligibility and informed consent obtained. Patients will be monitored for clinical toxicity by standard NIH criteria. QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) and EORTC QLQ Head and Neck. A time period of 4 weeks will constitute the time for clinical safety monitoring.

Time frame: 4 weeks

Complete Response (CR)

CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.

Time frame: after the completion of the chemoradiotherapy treatment (up to 9 weeks)

Overall Survival(OS)

The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.

Time frame: 2 years

Locoregional Relapse-Free Survival(LRRFS)

The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.