A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
18 Years
69 Years
Both
Nasopharyngeal Carcinoma
Trial Information
A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Failure-free survival
Outcome Description:
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
Outcome Time Frame:
2-yr
Safety Issue:
Yes
Principal Investigator
Jun Ma, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Sun Yat-sen University
Authority:
China: Ethics Committee
Study ID:
YP2008004
NCT ID:
NCT00677118
Start Date:
June 2006
Completion Date:
January 2016
Related Keywords:
- Nasopharyngeal Carcinoma
- Nasopharyngeal carcinoma
- Concurrent chemoradiotherapy
- Adjuvant chemotherapy
- Clinical trial
- Carcinoma
- Nasopharyngeal Neoplasms
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