Clinical trial NCT05780372: Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma
Official title: Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: a Multi-center, Non-inferiority, Open-label, Randomized Controlled Phase III Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Radiotherapy; Complications
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Jiangxi Provincial Cancer Hospital
name: Zhejiang Cancer Hospital
name: Chongqing University Cancer Hospital
name: Dongguan People's Hospital
name: LiuZhou People's Hospital
First posted: 2023-03-22
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Regional recurrence-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Local recurrence-free survival
timeFrame: 3 years
measure: Distant metastasis-free survival
timeFrame: 3 years
measure: Progression free survival
timeFrame: 3 years
measure: Acute toxicities
timeFrame: From the start of treatment until 3 months post treatment
measure: Late toxicities
timeFrame: 3 years post treatment
measure: Quality of life score
timeFrame: During treatment and 3 years post treatment
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Dongguan
country: China
facility: Dongguan People Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou Worker's Hospital
state: Guangxi
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital of Nanchang University
state: Jiangxi
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Sun Yat-sen University
name: Chong Zhao, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: