Reducing Dose and Irradiated Volume in Cervical Prophylactic Irradiation for Nasopharyngeal Cancer

Phase 3, Prospective, Randomized, Open-Label Study on Simultaneously Reducing Both the Dose and the Irradiated Volume of Cervical Prophylactic Irradiation in Nasopharyngeal Cancer

The purpose of this study is to investigate whether reducing both the dose and the irradiated volume of cervical prophylactic irradiation in patients with nasopharyngeal cancer can maintain efficacy while decreasing toxicity. This will be achieved through a comparison of standard cervical prophylactic irradiation with a reduced-dose and reduced-volume approach.

Study Overview

• Status: Not yet recruiting
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Radiation: IMRT with reduced-dose and reduced-volume cervical prophylactic irradiation

Detailed Description

Patients with non-metastatic nasopharyngeal cancer who are candidates for receiving definitive IMRT are randomly assigned to receive either standard cervical prophylactic irradiation or a reduced-dose and reduced-volume approach. The standard arm receives the conventional dose and volume of irradiation, while the experimental arm receives a lower dose and a smaller irradiated volume. Both groups will undergo intensity-modulated radiotherapy (IMRT) to the primary tumor and involved lymph nodes. The primary endpoint of this study is regional-control (RC), and secondary endpoints include overall survival (OS), local control (LC), distant metastasis-free survival (DMFS), and toxicity. All efficacy analyses will be conducted in the intention-to-treat population, and the safety population will include only patients who receive their randomly assigned treatment.

• Study Type: Interventional
• Enrollment (Estimated): 474
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shaojun Lin, DR; Phone Number: 13860603879; Email: linshaojun@yeah.net
• Study Contact Backup: Name: Qiaojuan Guo, DR; Phone Number: 15080013157; Email: guoqiaojuan163@.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
2. No distant metastatic;
3. Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;
4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
5. Signing informed consent;
6. Follow up regularly and comply with test requirements.

Exclusion Criteria:

1. Disease progression during IMRT;
2. Previous malignancy or other concomitant malignant diseases;
3. The evaluation information of tumor efficacy can not be obtained;
4. Receive blind treatment in other clinical research;
5. Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);
6. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;
7. Active systemic infection;
8. No or limited capacity for civil conduct;
9. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
10. Pregnancy or lactation period;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; The experimental arm receives IMRT to the primary tumor and involved lymph nodes, with a reduced dose and volume of cervical prophylactic irradiation.	Radiation: IMRT with reduced-dose and reduced-volume cervical prophylactic irradiation; For N0 disease, only cover bilateral RPN and level II. For N1 disease, cover ipsilateral involved level plus subsequent level downword, and cover contralateral level RPN and level II. For N2 disease, cover ipsilateral involved level plus subsequent level downword. For N3 disease, cover ipsilateral involved level plus subsequent level downword, and ensuring a 2cm margin below GTVn if GTVn reach or near the sternoclavicular joint. Notably, for unilateral N3, the contralateral neck would only include RPN and level II. Prescribing dose for CTVn2 was 50Gy/33Fx.
No Intervention: Control Group; The standard arm receives IMRT to the primary tumor and involved lymph nodes, with conventional cervical prophylactic irradiation according to 2024 CSCO guideline. Prescribing dose for CTVn2 was 56Gy/33Fx.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional failure-free survival	The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events		3 years
Local failure-free survival (LFFS)	The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.	3 years
Distant metastasis-free survival	The distant metastasis-free survival rate will be estimated using Kaplan-Meier	3 years
Overall Survival	time from the date of the start of chemotherapy to death due to any cause	3 years
Incidence of acute and late toxicity		3 years

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital
• Investigators: Study Chair: Shaojun Lin, DR, Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
• Other Study ID Numbers: CerviReduce

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No