Actively Recruiting
Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma.
Led by Ming-Yuan Chen · Updated on 2024-07-31
384
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
M
Ming-Yuan Chen
Lead Sponsor
F
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare surgery plus reduced target chemoradiotherapy with surgery plus reduced dose chemoradiotherapy in newly diagnosed operable Nasopharyngeal Carcinoma.The main questions it aims to answer are:whether endoscopic surgery combined with reduced dose chemoradiotherapy vs surgery plus target reduction chemoradiotherapy can bring substantial survival benefits, lower toxicity, and shorter treatment cycle for patients with operable nasopharyngeal carcinoma .
CONDITIONS
Official Title
Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Performance Status Score 0-1 points
- Histologically or cytologically confirmed non-keratinized nasopharyngeal carcinoma (WHO type II or III)
- Surgically resectable primary nasopharyngeal lesions including T1, T2, T3 with tumor diameter ≤1.5cm
- Resectable retropharyngeal lymph nodes ≤1.5cm diameter with intact tissue space and no extranodal invasion
- Resectable cervical lymph nodes ≤3cm diameter, above lower edge of cricoid cartilage, moderately mobile, no extranodal invasion
- Clinical stage T1-3N1-2M0 or T2-3N0M0 (Stage II-III) per AJCC 8th edition
- Adequate organ function as defined by blood counts and liver, kidney tests within specified limits
- Signed informed consent and willingness to follow all study procedures
You will not qualify if you...
- Recurrent or distant metastatic nasopharyngeal carcinoma or other malignancy
- Severe organ dysfunction or physical disorders preventing surgery, radiotherapy, or chemotherapy
- Retropharyngeal lymph node diameter >1.5cm or extranodal invasion including carotid artery or muscle
- Cervical lymph node diameter >3cm, located below lower margin of cricoid cartilage, or extranodal invasion including carotid artery, skin, muscle, mediastinal structures, prevertebral fascia, cervical spine, or extensive spread
- Unable to cooperate with regular follow-up due to psychological, social, domestic, or geographic reasons
- Pregnancy or lactation
- Other conditions deemed exclusionary by the chief physician
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000
Actively Recruiting
Research Team
M
Ming-Yuan Chen, MD,PhD
CONTACT
Y
You-Ping Liu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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