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

ConditionsNasopharyngeal CarcinomaIntensity Modulated RadiotherapySurgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endoscopic nasopharyngectomy followed close follow-up

    Procedure/Surgery

    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

    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.

Treatment groups

442 Participants
are divided into 2 treatment groups
Group A: Surgery plus close follow-upExperimental treatment 1 intervention
Group B: Intensity modulated radiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

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

Time frame
5 years
2

Incidence of ≥3 grade adverse events

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

Time frame
5 years

Secondary outcomes

1

Local Regional Relapse-Free Survival (LRRFS)

Defined as the time from randomisation to the date of first locoregional relapse.

Time frame
5 years
2

Distant Metastasis-Free Survival (DMFS)

Defined as the time interval from randomisation to the date of first distant metastases.

Time frame
5 years
3

Progress-Free Survival (PFS)

Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.

Time frame
5 years
4

The proportion of patients with treatment related complications

The proportion of patients with treatment related complications according to NCI-CTC5.0 criteria and RTOG criteria.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

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

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

Source ClinicalTrials.gov
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