Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Newly Diagnosed Resectable Nasopharyngeal Carcinoma

Sun Yat-sen University

Status: Enrolling

Conditions: Nasopharyngeal Carcinoma

Treatments: Radiation: regular intensity-modulated radiotherapy; Procedure: surgery; Drug: Gemcitabine; Drug: Cisplatin; Radiation: Target-reduction intensity-modulated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05352321

SYSUCC-CMY-2022-122-01

Details and patient eligibility

About

Through a prospective clinical trial, we intend to combine surgery, 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 surgery could bring patients better local-regional control and lower adverse reactions.

Enrollment: 264 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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, T2-3N0M0 (Stage II-IVA) according to AJCC v8.
• Patients with cervical lymph nodes evaluated as surgically resectable before chemotherapy, including cervical lymph nodes with no invasion (encasement) of the common or ICA, the epidermis, mediastinal structures, prevertebral fascia, or cervical vertebrae.
• Patients with retropharyngeal lymph nodes evaluated as surgically resectable before chemotherapy, including simple RPLNs with intact capsule or RPLNs ≤ 1.5cm with mouth opening range > 4cm.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 2 patient groups

Surgery Plus Target-reduction Chemoradiotherapy

Experimental group

Description:

Surgery: Endoscopic nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy. Retropharyngeal lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy or da Vinci robotics. Neck lymph node dissection: Selective neck dissection of the region where the positive lymph nodes are located. Induction Chemotherapy for stage III-IVa: Gemcitabine, 1000 mg/m2, Day 1 and Day 8, Q3W, 3 cycles Cisplatin, 80 mg/m2, Day 1, Q3W, 3 cycles Intensity-modulated Radiotherapy with GTV and CTV1 reduction: CTV2 : 54.12Gy/33Fr/1.64Gy Concurrent Chemotherapy: Cisplatin, 100 mg/m2, intravenously, Day 1, Q3W during radiotherapy

Treatment:

Drug: Gemcitabine

Radiation: Target-reduction intensity-modulated radiotherapy

Procedure: surgery

Drug: Cisplatin

Regular Chemoradiotherapy

Active Comparator group

Description:

Induction Chemotherapy for stage III-IVa: Gemcitabine, 1000 mg/m2, intravenously within 30min, Day 1 and Day 8, Q3W, 3 cycles Cisplatin, 80 mg/m2, intravenously, Day 1, Q3W, 3 cycles Intensity-modulated Radiotherapy: GTVnx (nasopharyngeal lesions): 69.96Gy/33Fr/2.12Gy GTVrnd (retropharyngeal lymph nodes): 69.96Gy/33Fr/2.12Gy GTVnd: 69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82Gy CTV2: 54.12Gy/33Fr/1.64Gy Concurrent Chemotherapy: Cisplatin, 100 mg/m2, intravenously, Day 1, Q3W during radiotherapy

Treatment:

Drug: Gemcitabine

Radiation: regular intensity-modulated radiotherapy

Drug: Cisplatin