Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMing-Yuan Chen

About this trial

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 .

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Surgery combined with Target-reduction intensity-modulated radiotherapy
  • Surgery combined with Dose-reduction intensity-modulated radiotherapy

Treatment groups

384 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ming-Yuan Chen

Lead sponsor

Sun Yat-sen University

Sponsor institution

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborator

Sun Yat-sen University

Collaborator

Fifth Affiliated Hospital of Guangzhou Medical University

Collaborator

Huazhong University of Science and Technology Union Shenzhen Hospital

Collaborator

The First Affiliated Hospital of University of South China

Collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

Collaborator

Nanchang City First Hospital

Collaborator