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

May 9, 2008
July 11, 2013
June 2006
March 2015   (final data collection date for primary outcome measure)
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.
disease free survival [ Time Frame: 2-yr ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00677118 on ClinicalTrials.gov Archive Site
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.
Overall survival [ Time Frame: 2-yr ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Nasopharyngeal Carcinoma
  • 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
  • Drug: Cisplatin
    Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy.
    Other Name: Cisplatin
  • Experimental: Concurrent and adjuvant
    Concurrent chemoradiotherapy plus adjuvant chemotherapy
    Intervention: Drug: Cisplatin,fluorouracil
  • Active Comparator: Concurrent
    Concurrent chemoradiotherapy
    Intervention: Drug: Cisplatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
506
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00677118
YP2008004
Yes
Jun Ma, Sun Yat-sen University Cancer Center
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
Study Chair: Jun Ma, M.D. Sun Yat-sen University
Sun Yat-sen University
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP