A Phase 3 interventional study of Nedaplatin and Cisplatin in Nasopharyngeal Carcinoma, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-10-28.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
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.
6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.
This study's enrollment of 402 is above the median of 45 across 5,167 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nedplatin combine with IMRT
Drug: Nedaplatin
Cisplatin combine with IMRT
Drug: Cisplatin
Nedaplatin 100mg/m2(3 weekly),D1,D22,D43 of RT
Also known as: NDP
Cisplatin 100mg/m2(3 weekly),D1,D22,D43 of RT
Also known as: DDP
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
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
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: before chemoradiotherapy and after chemoradiotherapy
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sun Yat-sen University