NCT06529562 Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma.

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 384 participants in total. It began in 2022-11-01 with a primary completion date of 2032-11-01.

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 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

Inclusion Criteria: * 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 Criteria: * 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.

Contact & Investigator

Frequently Asked Questions

Related Trials