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

Official title

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

Overview

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.

Interventions

• 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 inclu

Primary outcome measures

• Regional failure-free survival [Time frame: 3 years]

Secondary outcome measures (5)

• Overall Survival [Time frame: 3 years]
• Local failure-free survival (LFFS) [Time frame: 3 years]
• Distant metastasis-free survival [Time frame: 3 years]
• Number of participants with adverse events [Time frame: 3 years]
• Incidence of acute and late toxicity [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06775756 · CerviReduce

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗