Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Primary Locally Resectable Nasopharyngeal Carcinoma

• Status: Recruiting
• Trial end date: 2028-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Through a prospective clinical trial, we intend to combine endoscopic nasopharyngectomy, induction chemotherapy, target-reduction intensity-modulated radiotherapy and concurrent chemotherapy as an experimental treatment for patients with newly diagnosed resectable nasopharyngeal carcinoma to illuminate whether combined endoscopic nasopharyngectomy could bring patients better local control and lower adverse reactions.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• Performance Status Score 0-1 points.

• Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically.

• Patients with primary nasopharyngeal lesions evaluated as surgically resectable before chemotherapy, including T1 (tumor limited to nasopharynx), T2 (tumor limited to the surface of parapharyngeal space) and T3 (tumor limited to the bottom wall of sphenoid sinus or pterygoid process). Clinical stage: T1-3N1-3M0 (Stage II-IVA) according to AJCC v8.

• Adequate organ function: WBC ≥ 4×10^9 /L, NEUT ≥ 2×10^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10^9/L, TBIL ≤1.5 ULN (TBIL ≤3 ULN for patients with Gilbert Disease), ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min.

• Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.

Exclusion Criteria:

• Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.

• Suffering severe cardiopathy or pulmonary dysfunction with cardiac or pulmonary function no more than grade 3.

• Extensive recurrent primary tumour beyond the resectable area such as extensive invasion of the skull base or a distance from the tumour margins to the internal carotid artery of less than 0·5 cm.

• Retropharyngeal lymph node involved or adjacent to primary nasopharyngeal lesions (less than 0·5 cm).

• Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.

• During pregnancy or lactation.

• Other patients that the chief physician considered as illegal for this trial.