Hypofractionated radiotherapy for nasopharyngeal carcinoma

Efficacy and Safety of Hypofractionated Radiotherapy for Nasopharyngeal Carcinoma

This study is testing a new type of radiation treatment for nasopharyngeal cancer to see if it works better and is safer than the usual methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Second Affiliated Hospital of Hainan Medical University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Haikou, Hainan)
• Trial ID: NCT06796270 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of hypofractionated radiotherapy in patients with nasopharyngeal carcinoma (NPC), comparing it to conventional radiotherapy methods. NPC is a prevalent head and neck cancer, particularly in southern China, where radiotherapy is the primary treatment. The study aims to determine if hypofractionated radiotherapy can improve local control of tumor cells while minimizing damage to surrounding organs and reducing treatment duration. By addressing the accelerated reproliferation of tumor cells, the study seeks to enhance patient outcomes and quality of life.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with a confirmed diagnosis of nasopharyngeal carcinoma and an expected survival of at least six months.

Not a fit: Patients with severe comorbidities or those whose cancer has progressed beyond the evaluable stage may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective treatment options for patients with nasopharyngeal carcinoma, potentially improving survival rates and quality of life.

How similar studies have performed: While hypofractionated radiotherapy is a novel approach for NPC, similar studies in other cancers have shown promising results, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age 18-75 years, male or female；
2. Performance status ≤ 2 ;
3. Nasopharyngeal cancer patients diagnosed by pathology (including histology or cytology) , of nasopharyngeal non-keratonic carcinoma (differentiated or undifferentiated, whether TNM staging);
4. Have at least one evaluable lesion (according to Recist1.1 criteria)
5. Expected survival ≥6 months.
6. The main organs are functioning normally and meet the following standards: (1) Blood routine examination must meet the following criteria: (no blood transfusion within 14 days) a. HB ≥ 100g/L, b. WBC ≥3×10\^9/L c. ANC≥1.5×10\^9/L, d. PLT ≥100×10\^9/L; (2) Biochemical examination must meet the following standards: a. BIL\<1.5 times the upper limit of normal value (ULN), b. ALT and AST\<2.5ULN, GPT ≤1.5×ULN; c. Serum Cr≤1 ULN, endogenous creatinine clearance rate\>60ml/min (Cockcroft Gault formula);(3).Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;(4).The myocardial enzyme spectra were in the normal range.
7. Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the Clinical Investigation Plan tests and procedures.

Exclusion Criteria:

1. Pregnant or lactating women
2. As determined by the investigators, there were severe comorbidities that could not tolerate or complete radiation therapy.
3. There are contraindications in MRI;
4. Second primary malignancy exists;
5. Patients with severe complications,such as hypertension, coronary heart disease,mental disease or patients who had any allergies before;
6. Received any other research in the past 4 weeks before enrollment.

Where this trial is running

Haikou, Hainan

• The Second Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (Recruiting)

Study contacts

• Study coordinator: yuecan zeng, doctor

Conditions Nasopharyngeal Carcinoma; Hypofractionated radiotherapy