Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma

Not Applicable

Recruiting

• Conditions: Nasopharyngeal Carcinoma; Intensity-Modulated Radiotherapy
• Interventions: Radiation: Reduction CTVp1; Radiation: Non-reduction CTVp1

• Registration Number: NCT05994170
• Lead Sponsor: Zhongshan People's Hospital, Guangdong, China

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.

Study Timeline

• Study First Submitted: 2023-07-25
• Status Verified: 2023-08
• Study Start: 2023-08-04
• Study First Submitted QC: 2023-08-08
• Last Update Submitted: 2023-08-08
• Study First Posted: 2023-08-16
• Last Update Posted: 2023-08-16
• Primary Completion: 2026-08-04
• Study Completion: 2029-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 454

Inclusion Criteria

1. histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);
2. newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system
3. 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.
4. 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 )
5. no previous treatment for cancer；
6. a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability);
7. between 18 and 70 years old;
8. 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);
9. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduction CTVp1	Reduction CTVp1	CTVp1=GTVp+5mm
Non-reduction CTVp1	Non-reduction CTVp1	CTVp1=GTVp+5mm+whole nasopharynx

Primary Outcome Measures

Name	Time	Method
Local Relapse-free Survival(LRFS)	3 years	the time from randomization to documented local recurrence or death from any cause
Incidence of hearing impairment worse than graded 2	3 years	audiometry and symptoms graded according to the CTCAE (version 5.0).

Secondary Outcome Measures

Name	Time	Method
Acute toxicities	3 months	Occur within 3 months after IMRT according Common Terminology Criteria for Adverse Events Version 5.0
Overall survival (OS)	3 years	the time from randomization to documented death from any cause
Regional Relapse-free Survival(RRFS)	3 years	the time from randomization to documented regional recurrence or death from any cause
Distant metastasis-free survival (DMFS)	3 years	calculated from randomization to documented distant metastasis or death
Late toxicities	3 years	3 months after completion of radiotherapy graded according to both the Radiation Therapy Oncology Group criteria and the CTCAE (version 5.0)
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)	3 years	Patient reported quality-of-life data and higher scores indicated more severe symptoms
radiation-induced otitis media with effusion (OME)	3 years	Evaluated by tympanometry
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)	3 years	Patient reported quality-of-life data and higher scores indicated more severe symptoms
V60Gy	3 years	Volume that received at least 60Gy

Trial Locations

Locations (1)

Zhongshan City People's Hospital; 🇨🇳 Zhongshan, Guangdong, China