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

NCT06775756 | Not Yet Recruiting Phase 3

• 1 other identifier: CerviReduce
• Study Type: interventional
• Target: 474
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall Survival

  3 years

• Local failure-free survival (LFFS)

  3 years

• Distant metastasis-free survival

  3 years

• Number of participants with adverse events

  3 years

• Incidence of acute and late toxicity

  3 years

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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

Experimental Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Disease progression during IMRT;
• Previous malignancy or other concomitant malignant diseases;
• The evaluation information of tumor efficacy can not be obtained;
• Receive blind treatment in other clinical research;
• Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);
• Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;
• Active systemic infection;
• No or limited capacity for civil conduct;
• 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;
• Pregnancy or lactation period;

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Shaojun Lin, DR

  Fujian Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Shaojun Lin, DR

CONTACT

13860603879; linshaojun@yeah.net

Qiaojuan Guo, DR

CONTACT

15080013157; guoqiaojuan163@.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2030
• Last Updated: January 15, 2025

Record last verified: 2025-01