Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma Treated With Intensity-modulated Radiotherapy(IMRT): A Phase 3, Multicentre, Randomised Controlled Trial(CTVp1-NPC)

Zhongshan People's Hospital, Guangdong, China1 site in 1 country454 target enrollmentAugust 4, 2023

ConditionsNasopharyngeal Carcinoma Intensity-Modulated Radiotherapy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nasopharyngeal Carcinoma
Sponsor: Zhongshan People's Hospital, Guangdong, China
Enrollment: 454
Locations: 1
Primary Endpoint: Local Relapse-free Survival(LRFS)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the long-term local control, survival rate, acute and late radiation related toxicities, quality of life after reducing high risk primary tumor clinical target volumes (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.

Detailed Description

This phase 3, multicenter,randomized controlled clinical trial recruits patients with newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local control, survival rate, acute and late radiation related toxicities between the two groups.

Registry

clinicaltrials.gov

Start Date

August 4, 2023

End Date

September 1, 2029

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhongshan People's Hospital, Guangdong, China

Responsible Party

Principal Investigator

Gui-Qiong Xu

Clinical Professor

Zhongshan People's Hospital, Guangdong, China

Eligibility Criteria

Inclusion Criteria

•histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);
•newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system
•nasopharyngeal mass confined to one side of nasopharynx and did not exceed the midline(the line between the nasal septum and the midpoint of spinal cord/medulla) detected by electronic nasopharyngoscope (ENS) and magnetic resonance imaging (MRI). Pathological biopsy was recommended if it was unclear whether tumor invaded the contralateral side radiographically.
•planned to receive curative IMRT, Chemotherapy drugs should be administered according to Chinese Society of Clinical Oncology (CSCO) guidelines depending on the TNM stage;(T1N0: No chemotherapy required;T2N0：No chemotherapy or concurrent cisplatin chemoradiotherapy if there are adverse prognostic indicators such as Epstein-Barr virus (EBV) DNA\>4000 copies，node \>3cm or with extranodal extension;T1-2N1: concurrent cisplatin chemoradiotherapy;T3N0: concurrent cisplatin chemoradiotherapy; stage III-Iva: platinum-based neoadjuvant chemotherapy+ concurrent cisplatin chemoradiotherapy+/-metronomic capecitabine therapy )
•no previous treatment for cancer；
•a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability);
•between 18 and 70 years old;
•adequate hematologic, renal, and hepatic function: Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;Adequate liver function: ALT and AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;Adequate renal function: BUN and CRE ≤ 1.5×ULN , endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
•Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria

•receipt of treatment with palliative intent;
•receipt of previous treatment (radiotherapy, chemotherapy, or surgery \[except diagnostic procedures\]) to the nasopharynx;
•had disease progress after neoadjuvant chemotherapy in local advantage NPC
•presence of distant metastasis;
•Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
•Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
•Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
•lactation or pregnancy;
•Any other condition including Mental disorder,drug or alcohol addition;do not have full capacity for civil acts.

Outcomes

Primary Outcomes

Local Relapse-free Survival(LRFS)

Time Frame: 3 years

the time from randomization to documented local recurrence or death from any cause

Incidence of hearing impairment worse than graded 2

Time Frame: 3 years

audiometry and symptoms graded according to the CTCAE (version 5.0).

Secondary Outcomes

Acute toxicities(3 months)
Overall survival (OS)(3 years)
Regional Relapse-free Survival(RRFS)(3 years)
Distant metastasis-free survival (DMFS)(3 years)
Late toxicities(3 years)
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)(3 years)
radiation-induced otitis media with effusion (OME)(3 years)
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)(3 years)
V60Gy(3 years)