Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Sun Yat-sen University
Sponsor:
Collaborators:
Guangzhou Medical University
The First Affiliated Hospital of Guangdong Pharmaceutical University
Meizhou City Hospital Of Guangdong Provience
Information provided by (Responsible Party):
Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01540136
First received: February 22, 2012
Last updated: September 2, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: Nedaplatin
Drug: Cisplatin
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 372
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)
Arms Assigned Interventions
Experimental: Nedplatin
Nedplatin combine with IMRT
Drug: Nedaplatin
Nedaplatin 100mg/m2(3 weekly),D1,D22,D43 of RT
Other Name: NDP
Active Comparator: Cisplatin
Cisplatin combine with IMRT
Drug: Cisplatin
Cisplatin 100mg/m2(3 weekly),D1,D22,D43 of RT
Other Name: DDP

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540136

Contacts
Contact: Qiuyan Chen, MD,PhD 86-20-8734-3643 chenqy@sysucc.org.cn

Locations
China, Guangdong
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    maihq@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Guangzhou Medical University
The First Affiliated Hospital of Guangdong Pharmaceutical University
Meizhou City Hospital Of Guangdong Provience
Investigators
Principal Investigator: HaiQiang Mai, MD,Ph.D Cancer center
  More Information

Additional Information:
cancer  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Hai-Qiang Mai,MD,PhD, Deputy Director of the Department of Nasopharyngeal Carcinoma, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01540136     History of Changes
Other Study ID Numbers: Sun Yat-sen University
Study First Received: February 22, 2012
Last Updated: September 2, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Carcinoma
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nedaplatin
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014