Status:
RECRUITING
Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma.
Lead Sponsor:
Ming-Yuan Chen
Collaborating Sponsors:
Fifth Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 ma...
Detailed Description
Currently, the treatment of newly diagnosed non-metastatic nasopharyngeal carcinoma with intensity modulated radiotherapy as the core and chemotherapy with platinum-containing drugs has achieved good ...
Eligibility Criteria
Inclusion
- Performance Status Score 0-1 points.
- Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically.
- Patients with primary nasopharyngeal lesions evaluated as surgically resectable, including T1 (tumor limited to nasopharynx), T2 (tumor limited to the surface of parapharyngeal space) and T3 (tumor limited to the bottom wall of sphenoid sinus) and tumor diameter ≤1.5cm. Resectable retropharyngeal lymph nodes were defined as; The diameter was ≤ 1.5cm, the tissue space was intact, and there was no obvious extranodal invasion; The resectable cervical lymph nodes were defined as ≤ 3cm in diameter, located above the lower edge of the cricoid cartilage, with moderate mobility and no obvious extranodal invasion. Clinical stage: T1-3N1-2M0, T2-3N0M0 (Stage II-III) according to AJCC 8th staging edition.
- Adequate organ function: WBC ≥ 4×10\^9 /L, NEUT ≥ 2×10\^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10\^9/L, TBIL ≤1.5 ULN (TBIL ≤3 ULN for patients with Gilbert Disease), ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min.
- Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.
Exclusion
- 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 surgery or radiotherapy or chemotherapy.
- Retropharyngeal lymph node diameter\>1.5cm, or extranodal invasion, such as invasion of internal carotid artery, muscle, or extensive extracapsular dissemination.
- Cervical lymph node diameter\>3cm, or in the area below the lower margin of the cricoid cartilage, or with extranodal invasion, such as invasion of the internal carotid artery, skin, muscle, mediastinal structure, prevertebral fascia or cervical spine, or extensive extra-capsular spread, subcutaneous metastasis, etc.
- Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
- During pregnancy or lactation.
- Other patients that the chief physician considered as illegal for this trial.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2032
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT06529562
Start Date
November 1 2022
End Date
November 1 2032
Last Update
July 31 2024
Active Locations (1)
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1
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000