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

Nasopharyngeal Carcinoma Clinical Trial

— CTVp1-NPC  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05994170
• Other study ID #: ZSCPH-002
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2023
• Est. completion date: September 1, 2029

Study information

• Verified date: August 2023
• Source: Zhongshan People's Hospital, Guangdong, China
• Contact: Gui-qiong Xu
• Phone: +8613528109888
• Email: donna_shee[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 454
• Est. completion date: September 1, 2029
• Est. primary completion date: August 4, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• Reduction CTVp1
High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm)
• Non-reduction CTVp1
High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as whole nasopharynx as well as 5mm margin from GTVp( CTVp1=GTVp+5mm+whole nasopharynx)

Locations

Country	Name	City	State
China	Zhongshan City People's Hospital	Zhongshan	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhongshan People's Hospital, Guangdong, China	Sun Yat-sen University Cancer Centre

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Relapse-free Survival(LRFS)	the time from randomization to documented local recurrence or death from any cause	3 years
Primary	Incidence of hearing impairment worse than graded 2	audiometry and symptoms graded according to the CTCAE (version 5.0).	3 years
Secondary	Overall survival (OS)	the time from randomization to documented death from any cause	3 years
Secondary	Regional Relapse-free Survival(RRFS)	the time from randomization to documented regional recurrence or death from any cause	3 years
Secondary	Distant metastasis-free survival (DMFS)	calculated from randomization to documented distant metastasis or death	3 years
Secondary	Acute toxicities	Occur within 3 months after IMRT according Common Terminology Criteria for Adverse Events Version 5.0	3 months
Secondary	Late toxicities	3 months after completion of radiotherapy graded according to both the Radiation Therapy Oncology Group criteria and the CTCAE (version 5.0)	3 years
Secondary	Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)	Patient reported quality-of-life data and higher scores indicated more severe symptoms	3 years
Secondary	Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)	Patient reported quality-of-life data and higher scores indicated more severe symptoms	3 years
Secondary	radiation-induced otitis media with effusion (OME)	Evaluated by tympanometry	3 years
Secondary	V60Gy	Volume that received at least 60Gy	3 years