Clinical trial NCT00677118: Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Official title: A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
Concurrent chemoradiotherapy
Adjuvant chemotherapy
Clinical trial
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Fudan University
name: Zhejiang Cancer Hospital
name: Huazhong University of Science and Technology
name: Fifth Affiliated Hospital, Sun Yat-Sen University
name: Peking University Cancer Hospital & Institute
name: Guangdong Provincial People's Hospital
First posted: 2008-05-13
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Failure-free survival
timeFrame: 2-yr
Secondary outcomes:
measure: Overall survival, distant failure-free survival and locoregional failure-free survival
timeFrame: 2-yr
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jun Ma, M.D.
role: STUDY_CHAIR
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