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

NCT ID: NCT05352321

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2028-06-01

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery Plus Target-reduction Chemoradiotherapy

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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

for induction chemotherapy

Cisplatin

Intervention Type: DRUG

for induction and concurrent chemotherapy

surgery

Intervention Type: PROCEDURE

in experimental arm

Target-reduction intensity-modulated radiotherapy

Intervention Type: RADIATION

in experimental arm

Regular Chemoradiotherapy

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

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

for induction chemotherapy

Cisplatin

Intervention Type: DRUG

for induction and concurrent chemotherapy

regular intensity-modulated radiotherapy

Intervention Type: RADIATION

in active comparator arm

Interventions

Gemcitabine

for induction chemotherapy

Intervention Type: DRUG

Cisplatin

for induction and concurrent chemotherapy

Intervention Type: DRUG

regular intensity-modulated radiotherapy

in active comparator arm

Intervention Type: RADIATION

surgery

in experimental arm

Intervention Type: PROCEDURE

Target-reduction intensity-modulated radiotherapy

in experimental arm

Intervention Type: RADIATION

Other Intervention Names

Endoscopic nasopharyngectomy; Retropharyngeal lymphadenectomy; Neck lymph node dissection

Eligibility 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, 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming-Yuan Chen

Professor, Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming-yuan Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming-yuan Chen, MD, PhD

Role: CONTACT

chmingy@mail.sysu.edu.cn

02087342422

Rui You, MD, PhD

Role: CONTACT

chmingy@mail.sysu.edu.cn

13580439820

Facility Contacts

Ming-yuan Chen

Role: primary

chmingy@mail.sysu.edu.cn

86-20-8734-3361

Xiong Zou, MD, PhD

Role: primary

zouxiong@sysucc.org.cn

86-18620249205

Other Identifiers

SYSUCC-CMY-2022-122-01

Identifier Type: -

Identifier Source: org_study_id