Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Newly Diagnosed Resectable Nasopharyngeal Carcinoma
Not Applicable
Recruiting
- Conditions
- Nasopharyngeal Carcinoma
- Interventions
- Radiation: regular intensity-modulated radiotherapyProcedure: surgeryRadiation: Target-reduction intensity-modulated radiotherapy
- Registration Number
- NCT05352321
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 264
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery Plus Target-reduction Chemoradiotherapy Target-reduction intensity-modulated radiotherapy 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 Regular Chemoradiotherapy regular intensity-modulated radiotherapy 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 Regular Chemoradiotherapy Gemcitabine 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 Surgery Plus Target-reduction Chemoradiotherapy surgery 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 Surgery Plus Target-reduction Chemoradiotherapy Gemcitabine 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 Surgery Plus Target-reduction Chemoradiotherapy Cisplatin 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 Regular Chemoradiotherapy Cisplatin 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
- Primary Outcome Measures
Name Time Method Local Regional Relapse-Free Survival (LRRFS) 3 years The LRRFS is evaluated and calculated from the date of random assignment until the day of first local regional relapse or until the date of the last follow-up visit.
- Secondary Outcome Measures
Name Time Method Distant Metastasis-Free Survival (DMFS) 3 years The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) 3 years Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.
Progress-free survival (PFS) 3 years Progress-free survival is calculated from the date of randomization to the date of the first progression of any site or death or censored at the date of the last follow-up.
Overall Survival (OS) 3 years The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Incidence of treatment related acute complications 1 years The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.
Regional Relapse-Free Survival (RRFS) 3 years The RRFS was defined as the duration from the date of random assignment to the date of regional relapse or censored at the date of the last follow-up.
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) 3 years Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Incidence of treatment related late complications 3 years The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.
Trial Locations
- Locations (2)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Fifth Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China