Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Phase III Non-inferiority Study of Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Nedaplatin
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nedaplatin<br>Nedplatin combine with IMRT | Drug: Nedaplatin<br>* Nedaplatin 100mg/m2(3 weekly),D1,D22,D43 of RT<br>* Other names: NDP;|
| Active Comparator: Cisplatin<br>Cisplatin combine with IMRT | Drug: Cisplatin<br>* Cisplatin 100mg/m2(3 weekly),D1,D22,D43 of RT<br>* Other names: DDP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress-free survival | Progress-free survival is calculated from the date of randomization to the date of the first progress at any site. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 2 years | 
| Distant Metastasis-Free Survival (DMFS) | The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit. | 2 years | 
| Anti-neoplasms sensitization effects of chemotherapy to radiotherapy | Tumor response will be evaluated by physical examination and nasopharyngoscopy when radiotherapy in 20Gy、40Gy、70Gy. | radiotherapy in 20Gy、40Gy、70Gy | 
| Cost-effectiveness analysis | The determination of cost, including direct cost drug fees, inspection fees, expenses and nursing cost; cost-effectiveness analysis, such as cost-effectiveness ratio (ratio of the direct cost and short - and long-term curative effect) and incremental cost-effectiveness ratio (i.e., increasing costs and increase short or long-term efficacy ratio). | completion of chemoradiotherapy | 
| Correlate effects of CCRT with biomarkers of response and predictors of long-term outcome | Early identification of patients who will have more aggressive disease soon after diagnosis has been a major goal, we will investigate the correlate effects of CCRT with biomarkers of response and predictors of long-term outcome in these patients. | before chemoradiotherapy and after chemoradiotherapy |