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

NCT06533267 | Recruiting DMC

• 1 other identifier: SYSUCC-CMY-2024-02-24
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma; Intensity Modulated Radiotherapy; Surgery

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  Defined as the time interval from randomization to death due to any cause.

  5 years

• Incidence of ≥3 grade adverse events

  The proportion of patients with ≥3 grade adverse events according to CTCAE 5.0/RTOG criteria.

  5 years

Secondary Outcomes (7)

• Local Regional Relapse-Free Survival (LRRFS)

  5 years

• Distant Metastasis-Free Survival (DMFS)

  5 years

• Progress-Free Survival (PFS)

  5 years

• The proportion of patients with treatment related complications

  5 years

• Objective response rate (ORR)

  3 months

Study Arms (2)

Surgery plus close follow-up

EXPERIMENTAL

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

Procedure: Endoscopic nasopharyngectomy followed close follow-up

Intensity modulated radiotherapy

ACTIVE COMPARATOR

Radiotherapy: Intensity-modulated Radiotherapy: GTVnx: 69.96Gy/33Fr/2.12Gy CTV1: 59.4Gy/33Fr/1.8Gy CTV2: 54.12Gy/33Fr/1.64Gy

Radiation: Intensity-modulated Radiotherapy

Interventions

Endoscopic nasopharyngectomy followed close follow-up 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.

Surgery plus close follow-up

Intensity-modulated Radiotherapy 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.

Intensity modulated radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• Fifth Affiliated Hospital of Guangzhou Medical University: collaborator
• Huazhong University of Science and Technology Union ShenZhen Hospital (Nanshan Hospital): collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• First People's Hospital of Foshan: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator

Study Sites (1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Ming-Yuan Chen, MD,PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Yuan Chen, MD,PhD

CONTACT

+8613903052650; chmingy@email.sysu.edu.cn

Youping Liu, PhD

CONTACT

+86137517763276; liuyp78@email.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professior

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 1, 2024
• Study Start: March 25, 2024
• Primary Completion (Estimated): March 25, 2034
• Study Completion (Estimated): March 25, 2034
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

CN (1)