4 Cycles Of Neoadjuvant Chemotherapy Plus Concurrent Chemoradiation Versus Concurrent Chemoradiation Alone In Patients With Stage N2-3 Nasopharyngeal Carcinoma: A Phase 3 Multicenter Randomised Controlled Trial

NCT02512315 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Sun Yat-sen University
Phase	Phase 3
Status	UNKNOWN
Enrolment	192
Start date	2015-08
Completion	2024-12

Conditions

• Nasopharyngeal Carcinoma

Interventions

• Docetaxel (DOC)
• Cisplatin (DDP)
• Concurrent chemoradiation (CCRT)

Primary outcomes

• 5-year overall survival (5y-OS) — 5 years after the date of pathologic diagnosis
  Percentage of patients in a treatment group who are alive for a 5-year period of follow-up after the date of pathologic diagnosis
• 5-year distant-metastasis-free survival (5y-MFS) — 5 years after the date of pathologic diagnosis
  Percentage of patients in a treatment group who are alive without distant metastasis for a 5-year period of follow-up after the date of pathologic diagnosis

Countries

China