Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase III Non-inferiority Study of Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma|
- Progress-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
- Determine the toxic effects, both quantitatively and qualitatively, and quality of life (QoL) of these regimens in these patients. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]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) [ Time Frame: after the completion of the chemoradiotherapy treatment (up to 9 weeks) ] [ Designated as safety issue: No ]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) [ Time Frame: 2 years ] [ Designated as safety issue: No ]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) [ Time Frame: 2 years ] [ Designated as safety issue: No ]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) [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 [ Time Frame: radiotherapy in 20Gy、40Gy、70Gy ] [ Designated as safety issue: No ]Tumor response will be evaluated by physical examination and nasopharyngoscopy when radiotherapy in 20Gy、40Gy、70Gy.
- Cost-effectiveness analysis [ Time Frame: completion of chemoradiotherapy ] [ Designated as safety issue: No ]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 [ Time Frame: before chemoradiotherapy and after chemoradiotherapy ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Nedplatin combine with IMRT
Nedaplatin 100mg/m2(3 weekly),D1,D22,D43 of RT
Other Name: NDP
Active Comparator: Cisplatin
Cisplatin combine with IMRT
Cisplatin 100mg/m2(3 weekly),D1,D22,D43 of RT
Other Name: DDP
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540136
|Contact: Qiuyan Chen, MD,PhDemail@example.com|
|Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Haiqiang Mai, MD,Ph.D 86-20-8734-3643 firstname.lastname@example.org|
|Principal Investigator:||HaiQiang Mai, MD,Ph.D||Cancer center|