Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fudan University
Zhejiang Cancer Hospital
Huazhong University of Science and Technology
Fifth Affiliated Hospital, Sun Yat-Sen University
Beijing Cancer Hospital
Guangdong General Hospital
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00677118
First received: May 9, 2008
Last updated: July 11, 2013
Last verified: March 2010
  Purpose

The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients.


Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: Cisplatin,fluorouracil
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 Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Failure-free survival [ Time Frame: 2-yr ] [ Designated as safety issue: Yes ]
    Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.


Secondary Outcome Measures:
  • Overall survival, distant failure-free survival and locoregional failure-free survival [ Time Frame: 2-yr ] [ Designated as safety issue: Yes ]
    Overall survival is calculated from randomization to death from any cause. For distant failure-free survival and locoregional failure-free survival analyses, the latencies to the first remote or local failure, respectively, are recorded.


Estimated Enrollment: 506
Study Start Date: June 2006
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concurrent and adjuvant
Concurrent chemoradiotherapy plus adjuvant chemotherapy
Drug: Cisplatin,fluorouracil
Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy, then receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy.
Other Name: Cisplatin and fluorouracil
Active Comparator: Concurrent
Concurrent chemoradiotherapy
Drug: Cisplatin
Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy.
Other Name: Cisplatin

Detailed Description:

Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational arm)or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Patients in the investigational arm receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy. Patients are stratified according to the treatment centers. The primary end point was failure-free survival (FFS). Secondary end points included overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), the initial response rates after treatments, toxic effects and treatment compliance. All efficacy analyses were conducted in the intention-to-treat population; the safety population included only patients who received their randomly assigned treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type)
  2. Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system)
  3. No evidence of distant metastasis (M0)
  4. Performance status: KPS ≥70
  5. With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal)
  6. Renal: creatinine clearance ≥60ml/min
  7. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL
  8. Written informed consent

Exclusion Criteria:

  1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  2. Age ≥70 or <18
  3. With a history of renal disease
  4. Prior malignancy
  5. Previous chemotherapy or radiotherapy
  6. Patient is pregnant or lactating
  7. Unstable cardiac disease requiring treatment.
  8. Emotion disturbance
  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: NCT00677118

Locations
China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Fudan University
Zhejiang Cancer Hospital
Huazhong University of Science and Technology
Fifth Affiliated Hospital, Sun Yat-Sen University
Beijing Cancer Hospital
Guangdong General Hospital
Investigators
Study Chair: Jun Ma, M.D. Sun Yat-sen University
  More Information

Publications:
Freedman J, Furberg, C, DeMets D. Fundamentals of clinical trials. Springer-Verlag, NY, 1998.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jun Ma, Sun Yat-sen University Cancer Center
ClinicalTrials.gov Identifier: NCT00677118     History of Changes
Other Study ID Numbers: YP2008004
Study First Received: May 9, 2008
Last Updated: July 11, 2013
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
Nasopharyngeal carcinoma
Concurrent chemoradiotherapy
Adjuvant chemotherapy
Clinical trial

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 24, 2014