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

NCT ID: NCT06775756

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2030-04-01

Brief Summary

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.

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

IMRT with reduced-dose and reduced-volume cervical prophylactic irradiation

Intervention Type: RADIATION

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shaojun Lin, DR

Role: STUDY_CHAIR

Fujian Cancer Hospital

Central Contacts

Shaojun Lin, DR

Role: CONTACT

linshaojun@yeah.net

13860603879

Qiaojuan Guo, DR

Role: CONTACT

guoqiaojuan163@.com

15080013157

Other Identifiers

CerviReduce

Identifier Type: -

Identifier Source: org_study_id