Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Cisplatin,fluorouracil; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00677118

YP2008004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 506 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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506 participants in 2 patient groups

Concurrent and adjuvant

Experimental group

Description:

Concurrent chemoradiotherapy plus adjuvant chemotherapy

Treatment:

Drug: Cisplatin,fluorouracil

Concurrent

Active Comparator group

Description:

Concurrent chemoradiotherapy

Treatment:

Drug: Cisplatin