Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: a Multi-center, Non-inferiority, Open-label, Randomized Controlled Phase III Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780372
• Other study ID #: Reduced CTV in NPC
• Status: Recruiting
• Phase: Phase 3
• Start date: August 8, 2023
• Est. completion date: August 2029

Study information

• Verified date: November 2023
• Source: Sun Yat-sen University
• Contact: Chong Zhao, MD PhD
• Phone: 02087342638
• Email: zhaochong[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 474
• Est. completion date: August 2029
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
• All genders, range from 18-70 years old;
• ECOG score 0-1;
• Clinical stage I-IVa (AJCC/UICC 8th);
• Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
• No contraindications to chemotherapy or radiotherapy;
• Adequate organ function: white blood cell count = 4×109/L, neutrophile granulocyte count = 1.5×109/L, hemoglobin = 9g/L, platelet count = 100×109/L; alanine aminotransferase or aspartate aminotransferase < 2.5×upper limit of normal; blood urea nitrogen or creatinine = 1.5×upper limit of normal or endogenous creatinine clearance = 60ml/min (Cockcroft-Gault formula);
• Sign the consent form.

Exclusion Criteria:

• Neck lymph nodes exist skipping metastasis;
• Distant metastases;
• Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
• Have or are suffering from other malignant tumors;
• Participating in other clinical trials;
• Pregnancy or lactation;
• Have uncontrolled cardiovascular disease;
• Severe complication, eg, uncontrolled hypertension;
• Mental disorder;
• Drug or alcohol addition;
• Do not have full capacity for civil acts.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Radiotherapy; Complications

Intervention

Radiation:
• Intensity Modulated Radiation Therapy
All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).

Drug:
• Chemotherapy
Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.

Locations

Country	Name	City	State
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	Dongguan People Hospital	Dongguan	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Liuzhou Worker's Hospital	Liuzhou	Guangxi
China	Jiangxi Cancer Hospital of Nanchang University	Nanchang	Jiangxi
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (6)

Lead Sponsor	Collaborator
Sun Yat-sen University	Chongqing University Cancer Hospital, Dongguan People's Hospital, Jiangxi Provincial Cancer Hospital, LiuZhou People's Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional recurrence-free survival	From the date of randomization to regional recurrence or any death	3 years
Secondary	Overall survival	From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up	3 years
Secondary	Local recurrence-free survival	From the date of randomization to local recurrence or any death	3 years
Secondary	Distant metastasis-free survival	From the date of randomization to distant metastasis or any death	3 years
Secondary	Progression free survival	From the date of randomization to local or regional recurrence, distant metastasis or any death	3 years
Secondary	Acute toxicities	Assessed with CTCAE v5.0	From the start of treatment until 3 months post treatment
Secondary	Late toxicities	Assessed with RTOG/EORTC	3 years post treatment
Secondary	Quality of life score	Assessed with EORTC-Quality of life questionnaire-C30 version 3.0	During treatment and 3 years post treatment

External Links

•   Home Page of Cancer Center, Sun Yat-sen University