Endoscopic Surgery vs. Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma.

NCT ID: NCT06533267

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 442 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2034-03-25

Brief Summary

The goal of this clinical trial is to compare the survival and adverse reactions differences between endoscopic surgery and intensity modulated radiotherapy for patients with newly diagnosed stage Ⅰ nasopharyngeal carcinoma, aiming to verifying the efficacy and safety of endoscopic surgery for stage Ⅰ nasopharyngeal carcinoma.

Detailed Description

The newly diagnosed non-metastatic nasopharyngeal carcinoma has shown satisfactory therapeutic effect under the intensity modulated radiation. The 5-year survival rate of the newly diagnosed Ⅰ nasopharyngeal carcinoma was more than 95%. However, mos 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 primary lesion confined to nasopharyngeal mucosa and without regional lymph node metastasis, in theory, the primary lesion can be removed by minimally invasive surgery without need of preventive treatment of cervical lymph nodes according to the prior study.

Based on our previous research results, we stratified the nasopharyngeal primary tumor diameter of stage Ⅰ nasopharyngeal carcinoma by whether the short diameter of retropharyngeal lymph nodes and neck lymph nodes was smaller than 0.4cm and 0.6cm respectively, and the tumor diameter of nasopharyngeal primary tumor was ≤ 1.5cm. This study evaluated the efficacy and safety of endoscopic minimally invasive surgery compared to conventional intensity-modulated radiotherapy for these stage Ⅰ nasopharyngeal carcinoma.

In this study, the stage Ⅰ patients in the experimental group only received endoscopic nasopharynx resection and were followed up closely to monitor the recurrence and distant metastasis of the tumor.

The patients in the control group received conventional intensity-modulated radiotherapy and regular follow-up. The target area and dose of radiotherapy were as follows: GTVnx: primary lesion of the nasopharynx; CTV1: high-risk area and the entire nasopharynx; CTV2: low-risk area. The recommended intensity-modulated radiotherapy dose is GTVnx(69.96 Gy/33 Fr/2.12 Gy); CTV1(60.60 Gy/33 Fr/1.82 Gy); CTV2(54.12 Gy/33 Fr/1.64 Gy).

Conditions

Nasopharyngeal Carcinoma; Intensity Modulated Radiotherapy; Surgery

Study Design

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

Study Groups

Surgery plus close follow-up

Surgery:

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

Group Type: EXPERIMENTAL

Endoscopic nasopharyngectomy followed close follow-up

Intervention Type: PROCEDURE

Radical resection of primary lesion using nasal endoscopy.

After the treatment, the electronic nasal endoscopy was reviewed every two weeks to determine the healing of the wound, whether there was tumor recurrence, until the surgical wound was completely healed. The patients were followed up at least once every three months from the first year to the third year, at least once every six months from the fourth year to the fifth year, and at least once every year after five years.

Intensity modulated radiotherapy

Radiotherapy:

Intensity-modulated Radiotherapy:

GTVnx: 69.96Gy/33Fr/2.12Gy CTV1: 59.4Gy/33Fr/1.8Gy CTV2: 54.12Gy/33Fr/1.64Gy

Group Type: ACTIVE_COMPARATOR

Intensity-modulated Radiotherapy

Intervention Type: RADIATION

GTVnx (nasopharyngeal lesions): 69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82Gy CTV2: 54.12Gy/33Fr/1.64Gy.

After treatment, patients were followed up every 3-6 months from the first year to the third year, every 6-12 months from the fourth year to the fifth year, and at least once a year after five years.

Interventions

Endoscopic nasopharyngectomy followed close follow-up

Radical resection of primary lesion using nasal endoscopy.

After the treatment, the electronic nasal endoscopy was reviewed every two weeks to determine the healing of the wound, whether there was tumor recurrence, until the surgical wound was completely healed. The patients were followed up at least once every three months from the first year to the third year, at least once every six months from the fourth year to the fifth year, and at least once every year after five years.

Intervention Type: PROCEDURE

Intensity-modulated Radiotherapy

GTVnx (nasopharyngeal lesions): 69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82Gy CTV2: 54.12Gy/33Fr/1.64Gy.

After treatment, patients were followed up every 3-6 months from the first year to the third year, every 6-12 months from the fourth year to the fifth year, and at least once a year after five years.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Karnofsky score >70.
• Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) or carcinoma in situ confirmed histologically and/or cytologically.
• According to the eighth edition of UICC/AJCC staging, the patient was defined as T1N0M0 stage I.
• The maximum short diameters of retropharyngeal lymph nodes and cervical lymph nodes were not more than 0.4cm and 0.6cm respectively, or retropharyngeal lymph nodes and cervical lymph nodes were 0.4-0.5cm and 0.6-1.0cm respectively but PET/CT showed negative.
• Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.

Exclusion Criteria

• MRI showed that the primary tumor diameter >1.5cm, or internal carotid artery vascular malformation which would seriously affect the operation.
• 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 operation or radiotherapy.
• Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fifth Affiliated Hospital, 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 ShenZhen Hospital (Nanshan Hospital)

UNKNOWN

Sponsor Role: collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical 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

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming-Yuan Chen

Professior

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming-Yuan Chen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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

Youping Liu, PhD

Role: CONTACT

liuyp78@email.sysu.edu.cn

+86137517763276

Facility Contacts

Youping Liu, MD

Role: primary

liuyp78@email.sysu.edu.cn

+8613751763276

Other Identifiers

SYSUCC-CMY-2024-02-24

Identifier Type: -

Identifier Source: org_study_id