Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients

NCT ID: NCT03353467

Last Updated: 2021-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2028-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma Endoscopic Surgery Primary Napharyngeal Carcinama Stage I Nasopharyngeal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group in endoscopic surgery

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.

Group Type EXPERIMENTAL

Endoscopic surgery

Intervention Type PROCEDURE

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

Group in IMRT

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.

Group Type ACTIVE_COMPARATOR

Intensity-modulated radiotherapy

Intervention Type 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.

Interventions

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Endoscopic surgery

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

Intervention Type PROCEDURE

Intensity-modulated radiotherapy

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.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Ming-Yuan Chen

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ming-Yuan Chen, MD,Ph.D

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

The First People's Hospital of Foshan

Guangzhou, Guangdong, China

Site Status RECRUITING

Zhongshan People's Hospital

Zhongshan, Guangdong, China

Site Status RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ming-Yuan Chen, MD,Ph.D

Role: CONTACT

86-13903052650

Facility Contacts

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Ming-Yuan Chen, Prof.

Role: primary

86-20-8734-3361

Wei-Ping Wen, MD, PhD

Role: primary

86-13802966937

Jun Tang, MD

Role: primary

86-18038860199

Feng Lei

Role: primary

86-13528227676

Ming-Fang Ji

Role: backup

86-13532062222

Shen-Hong Qu, MD, PhD

Role: primary

86-15807813816

Other Identifiers

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2017-FXY-055-NPC

Identifier Type: -

Identifier Source: org_study_id

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