Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma

Phase 3

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Cisplatin; Drug: Nedaplatin

• Registration Number: NCT01540136
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-02-28
• Status Verified: 2013-03
• Primary Completion: 2014-05
• Study Completion: 2016-07
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cisplatin	Cisplatin	Cisplatin combine with IMRT
Nedaplatin	Nedaplatin	Nedplatin combine with IMRT

Primary Outcome Measures

Name	Time	Method
Progress-free survival	2 years	Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

Secondary Outcome Measures

Name	Time	Method
Determine the toxic effects, both quantitatively and qualitatively, and quality of life (QoL) of these regimens in these patients.	4 weeks	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.
Complete Response (CR)	after the completion of the chemoradiotherapy treatment (up to 9 weeks)	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.
Overall Survival(OS)	2 years	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.
Locoregional Relapse-Free Survival(LRRFS)	2 years	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.
Distant Metastasis-Free Survival (DMFS)	2 years	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.
Anti-neoplasms sensitization effects of chemotherapy to radiotherapy	radiotherapy in 20Gy、40Gy、70Gy	Tumor response will be evaluated by physical examination and nasopharyngoscopy when radiotherapy in 20Gy、40Gy、70Gy.
Cost-effectiveness analysis	completion of chemoradiotherapy	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).
Correlate effects of CCRT with biomarkers of response and predictors of long-term outcome	before chemoradiotherapy and after chemoradiotherapy	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.

Trial Locations

Locations (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China