A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: neoadjuvant chemotherapy plus concurrent chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00705627

2007047

Details and patient eligibility

About

Locoregionally advanced nasopharyngeal carcinoma (NPC)(stage III, IV in UICC 2002 Classification) can be divided into two groups according to the risk of metastasis: high-risk metastasis group (T4 or N2-3) and low-risk metastasis group (T3N0-1). In low-risk metastasis group, concurrent chemoradiotherapy (CCRT) might decrease local recurrence and distance metastasis, which benefits overall survival. On the other hand, neoadjuvant chemotherapy is also associated with lower distance metastasis of advanced stage NPC. Nevertheless, CCRT alone or neoadjuvant chemotherapy alone leads to unsatisfactory results regarding to distance metastasis in patients with high-risk metastasis group. In this case, it is utmost important to investigate the new treatment combining neoadjuvant chemotherapy plus CCRT in order to improve overall survival of locoregionally advanced NPC with high-risk metastasis.

In our study, in order to investigate the effect and adverse reaction of neoadjuvant chemotherapy plus CCRT on distance metastasis and locoregionally relapse, four hundred patients with high risk of distance metastasis will be randomly divided into two groups, comparing neoadjuvant chemotherapy (DDP+5FU) plus CCRT (DDP) and CCRT (DDP) alone. We aim to find out the best therapeutic regimen with lowest adverse reaction for NPCS with high risk of distance metastasis.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with newly histologically confirmed nasopharyngeal carcinoma, including WHO II or III
• Original clinical stage must be T4 or N2-3 （UICC 2002）
• Male and no pregnant female
• Age between 18-60
• WBC ≥4,000/mm3 and PLT ≥ 100,000/mm3
• With normal liver function test (ALT、AST≤2.5×ULN)
• With normal renal function test (Creatinine ≤ 1.5×ULN)
• Performance status scale ECOG grade 0，1
• Without radiotherapy or chemotherapy
• Patients must give signed informed consent

Exclusion criteria

• Patients have evidence of relapse or distant metastasis
• The presence of uncontrolled life-threatening illness
• Receiving other ways of anti-cancer therapy
• Receiving radiotherapy or chemotherapy
• Investigator consider the patients can't finish the whole study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 1 patient group

B

Experimental group

Description:

Drug: cisplatin. Patients in the control arm received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.

Treatment:

Drug: neoadjuvant chemotherapy plus concurrent chemoradiotherapy