Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Radiotherapy; Complications; Nasopharyngeal Carcinoma

Treatments: Radiation: Intensity Modulated Radiation Therapy; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05780372

Reduced CTV in NPC

Details and patient eligibility

About

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.

Enrollment: 474 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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474 participants in 2 patient groups

Reduced CTVn2

Experimental group

Description:

Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level.

Treatment:

Drug: Chemotherapy

Radiation: Intensity Modulated Radiation Therapy

Conventional CTVn2

Active Comparator group

Description:

Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline.

Treatment:

Drug: Chemotherapy

Radiation: Intensity Modulated Radiation Therapy