Surgery Alone Verus Sugery Combined with Dose-reduced Radiotherapy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma

NCT ID: NCT06688760

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2028-11-01

Brief Summary

The goal of this clinical trial is to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph nodes dissection plus bilateral upper neck lymph node dissection or plus postoperative low-dose radiotherapy in newly diagnosed stage Ⅰ nasopharyngeal carcinoma.

Detailed Description

At present, the newly diagnosed non metastatic nasopharyngeal carcinoma has achieved good therapeutic effect under the treatment scheme of intensity modulated radiotherapy. The 5-year survival rate of the newly diagnosed stage Ⅰ nasopharyngeal carcinoma was more than 95%. But at the same time, all patients receiving radical radiotherapy will experience different degrees of acute or chronic radiation injury, which will affect the quality of life of patients to varying degrees. For stage Ⅰ nasopharyngeal carcinoma with the primary lesion confined to the nasopharyngeal mucosa and without regional lymph node metastasis, in theory, the primary lesion can be removed by minimally invasive surgery without preventive treatment of cervical lymph nodes.

Our previous research results showed that endoscopic surgery could achieved similar survival outcomes but less adverse events than radiotherapy for Stage Ⅰ nasopharyngeal carcinoma with short diameter of retropharyngeal lymph nodes<0.4cm or short diameter of cervical lymph nodes<0.6 and negative PET/CT findings. However, if there is the same results for all stage I NPC patients is still unclear. Therefore, this study aims to compare the efficacy and safety of endoscopic nasopharyngectomy combined with retropharyngeal lymph node dissection combined with low-dose radiotherapy or bilateral upper neck lymph node dissection compared with conventional intensity-modulated radiotherapy.

When the patients participated in this study, the stage ⅠNPC patient of experimental group 1 received endoscopic nasopharyngectomy combined with retropharyngeal lymph node dissection and low-dose radiotherapy. Low dose radiotherapy target area: CTV1 (tumor bed area); For the primary lesion with negative margin but less than 3mm, the margin area should be included; For patients with extracapsular invasion of lymph nodes, the extracapsular invasion area should be included; It should also include all cervical lymph nodes located above the cricoid cartilage detected by CT/MRI, regardless of size; CTV2: low risk infiltration area. The prescription dose of intensity modulated radiotherapy: CTV1:36.00gy/15fr/2.40gy; CTV2:30.00gy/15fr/2.00gy. The patients in the stage Ⅰ in the experimental group 2 underwent endoscopic nasopharynx resection combined with retropharyngeal lymph node resection and bilateral upper neck lymph node dissection, without radiotherapy or chemotherapy after surgery.

Conditions

Nasopharyngeal Carcinoma; Surgery; Radiotherapy

Study Design

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

Study Groups

Surgery plus low dose radiotherapy

Surgery:

Endoscopic Nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy.

Retropharyngeal Lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy.

Radiotherapy:

Low Dose Raiotherapy:

Low dose radiotherapy target area: CTV1: tumor bed area; For cases where the margin of the primary lesion is negative but less than 3mm, the margin area should be included; It should also include all cervical lymph nodes located above the cricoid cartilage detected by CT/MRI, regardless of size; CTV2: Low risk infiltration area.

Intensity modulated radiation therapy prescription dose: CTV1: 36.00Gy/15Fr/2.40Gy; CTV2: 30.00Gy/15Fr/2.00Gy.

Group Type: EXPERIMENTAL

Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy

Intervention Type: PROCEDURE

in experimental arm 1

Surgery

Endoscopic Nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy.

Retropharyngeal Lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy.

Bilateral Upper Neck Lymph Node Dissection: the specific cleaning area is the lymph nodes upon the Hyoid bone regions.

Group Type: EXPERIMENTAL

Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy

Intervention Type: PROCEDURE

in experimental arm 1

Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection

Intervention Type: PROCEDURE

in experimental arm 2

Interventions

Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Low Dose Radiotherapy

in experimental arm 1

Intervention Type: PROCEDURE

Endoscopic nasopharyngectomy combine Retropharyngeal lymphadenectomy and Double upper neck lymph node dissection

in experimental arm 2

Intervention Type: PROCEDURE

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.
• According to the UICC/AJCC eighth edition staging, the patient is defined as T1N0M0 stage I.
• 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, 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 organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy.
• 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

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Fifth Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Huazhong University of Science and Technology Union Hospital (Nanshan Hospital)

UNKNOWN

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

First People's Hospital of Foshan

OTHER

Sponsor Role: collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

Sponsor Role: collaborator

Ming-Yuan Chen

OTHER

Sponsor Role: lead

Responsible Party

Ming-Yuan Chen

Professior,Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ming-Yuan Chen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

SUN yet-sen University

Locations

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming-Yuan Chen, MD,PhD

Role: CONTACT

chmingy@email.sysu.edu.cn

+8613903052650

You-Ping Liu, PhD

Role: CONTACT

liuyp78@email.sysu.edu.cn

+8613751763276

Facility Contacts

Mingyuan Chen, PhD.

Role: primary

chmingy@mail.sysu.edu.cn

+8613903052650

Youping Liu, PhD.

Role: primary

liuyp78@email.sysu.edu.cn

+8613751763276

Other Identifiers

SYSUCC-CMY-2024-02-25

Identifier Type: -

Identifier Source: org_study_id