A Trial On 4 Cycles Of Neoadjuvant Chemotherapy Plus Concurrent Chemoradiation In N2-3 Nasopharyngeal Carcinoma

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The standard treatment strategy of locally advanced nasopharyngeal carcinoma (NPC) nowadays is concurrent chemoradiation (CCRT) based on intensity-modulated radiation therapy (IMRT). However, distant metastasis remains the major cause of treatment failure, especially in patients with T1-4N2-3M0 diseases (N2-3 NPC). The investigators inferred that it was more appropriate to consider N2-3 NPC as a systemic disease instead of a local disease. NACT of sufficient intensity such as 4 cycles might be effective enough for control of the pre-existing micrometastases. Therefore, the objective of this phase 3 multicenter randomized controlled trial is to make a comparison between NACT of 4 cycles plus CCRT based on IMRT and CCRT alone in N2-3 NPC on distant metastasis, survival and adverse reaction.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

• Patients with pathological diagnosis of nasopharyngeal carcinoma

• Union Internationale Contre le Cancer/American Joint Cancer Committee (UICC/AJCC) 2010 Stage T1-4 N2-3 M0 through magnetic resonance imaging of head and neck, whole-body bone scan and thoracoabdominal computed tomography

• Male or female with age no older than 70 years old

• Karnofsky Performance Scores ≥ 80

• Expected survival ≥ 3 months

Exclusion Criteria:

• Patients with distant metastasis before or during radiotherapy

• Severe dysfunction of heart, lung, liver, kidney or hematopoietic system

• Severe neurological, mental or endocrine diseases

• History of other malignancies

• Prior chemotherapy, radiotherapy or application of monoclonal antibodies

• Patients participated in clinical trials of other drugs within last 3 months

• Pregnant or lactating women

• Those who are considered by the researchers unsuitable to participate