Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients

NCT03353467 | Recruiting

• 1 other identifier: 2017-FXY-055-NPC
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 5

Brief Summary

Nasopharyngeal carcinoma (NPC) is most prevalent in eastern Asia, with the highest incidence reported among the Cantonese population from the province of Guangdong. Radiotherapy is the cornerstone of initial treatment due to the radiosensitive behavior of NPC and its deep-seated location. Although radiotherapy has achieved satisfactory results, it can also cause some severe adverse events. Currently, surgery is only applied to the treatment of recurrent NPC (rNPC) patients, mainly dominated by the conventional open surgery. However, the traditional surgery was accompanied by high rate of treatment-induced complications and low rate of block removal, which greatly limited the surgical application to the treatment of primary NPC. With the continuous improvement in surgical techniques, especially the electronic endoscopic system to be used in the surgical treatment recently, endoscopic nasopharyngectomy can largely overcome these shortcomings of traditional surgery mentioned above. In addition, the investigators retrospectively analyzed the survival outcomes of 9 patients with NPC (all T1N0M0 according to the UICC / AJCC seventh staging) treated with endoscopic nasopharyngectomy in our hospital, with 5-year rate of overall survival, loco-regional-free survival, distant metastasis-free survival of 100%. Therefore, the investigators considered endoscopic nasopharyngectomy for staged I NPC patients feasible. This study will focus on the survival outcomes and quality of life of the staged I NPC patients treated with endoscopic nasopharyngectomy.

Conditions

Nasopharyngeal Carcinoma; Endoscopic Surgery; Primary Napharyngeal Carcinama; Stage I Nasopharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

• overall survival

  The event for overall survival (OS) was death from any cause. The duration was calculated from the date of treatment initiation to the date of death or last follow-up.

  3 years

Secondary Outcomes (3)

• distant metastasis-free survival

  3 years

• loco-regional relapse-free survival

  3 years

• the rates of complications

  1 year

Study Arms (2)

Group in endoscopic surgery

EXPERIMENTAL

Stage I patients were only treated with endoscopic surgery without additional chemotherapy. Endoscopic nasopharyngectomy included endoscopic resection , with or without posterior pedicle nasal mucoperiosteal flap resurfacing the nasopharyngeal defects.

Procedure: Endoscopic surgery

Group in IMRT

ACTIVE COMPARATOR

Stage I patients were only treated with radical intensity-modulated radiotherapy without additional chemotherapy. IMRT was delivered with a dynamic multileaf intensity-modulating collimator (NOMOS, Sewickley, PA) by a slice-by-slice arc rotation approach.

Radiation: Intensity-modulated radiotherapy

Interventions

Endoscopic surgery PROCEDURE

Endoscopic nasopharyngectomy included endoscopic resection, with or without posterior pedicle nasal mucoperiosteal flap resurfacing the nasopharyngeal defects.

Group in endoscopic surgery

Intensity-modulated radiotherapy RADIATION

All of the patients were received irradiation by IMRT. The target volumes were delineated according to a previously described institutional treatment protocol, which is in accordance with the International Commission on Radiation Units and Measurements reports 50 and 62.

Group in IMRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated, biopsy-proven World Health Organization (WHO) types II or III NPC; Stage I disease (American Joint Committee on Cancer 7th edition); Between 18 and 70 years old; Adequate bone marrow, liver and renal function; Satisfactory performance status: a score of 0 or 1 using the Eastern Cooperative Oncology Group System; Patients provided signed informed consent.

You may not qualify if:

• Evidence of relapse or distant metastasis; History of prior malignancy or previous treatment for NPC; The presence of uncontrolled life-threatening diseases; The investigator considered the patient unable to complete the study.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• First People's Hospital of Foshan: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator

Study Sites (5)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

The First People's Hospital of Foshan

Guangzhou, Guangdong, 528000, China

RECRUITING

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms

Interventions

Endoscopy; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Ming-Yuan Chen, MD,Ph.D

  Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Ming-Yuan Chen, MD,Ph.D

CONTACT

86-13903052650; chmingy@mail.sysu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 27, 2017
• Study Start: October 1, 2017
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 3, 2021

Record last verified: 2021-05

Locations

CN (5)