RecruitingNot ApplicableNCT06533267

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

Endoscopic Surgery Compared With Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma : A Multicenter, Randomized Controlled Clinical Trial.


Sponsor

Sun Yat-sen University

Enrollment

442 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for very early-stage nasopharyngeal carcinoma (cancer of the back of the nose and throat): minimally invasive endoscopic surgery (going through the nose with a camera) versus standard intensity-modulated radiation therapy (IMRT). Stage I nasopharyngeal cancer is small and has not spread to lymph nodes. Radiation is currently the standard, but surgery might achieve similar results with fewer long-term side effects from radiation. Researchers want to find out which approach is better. **You may be eligible if...** - You have been confirmed by biopsy or cytology to have WHO type II or III nasopharyngeal carcinoma (or carcinoma in situ) that is Stage I (T1N0M0) - Your lymph nodes are very small (within specific size limits on imaging) - You are in good functional health (Karnofsky score >70) - You are willing to follow the study protocol and attend follow-up visits **You may NOT be eligible if...** - Your primary tumor is larger than 1.5 cm on MRI, or has grown near major blood vessels - Your cancer has come back or spread to distant areas, or you have another cancer at the same time - You have severe organ problems that prevent surgery or radiation - You cannot reliably attend follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscopic 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.

RADIATIONIntensity-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.


Locations(1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

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NCT06533267


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