Clinical trial · Interventional
Hypofractionated Versus Conventionally Fractionated Radiotherapy for Initial Distant Metastases Nasopharyngeal Carcinoma
A Multicenter, Prospective, Randomized, Phase II Trial Evaluating Hypofractionated Versus Conventionally Fractionated Radiotherapy for Initial Distant Metastases Nasopharyngeal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radiotherapy is an important treatment for initial distant metastases nasopharyngeal carcinoma. Total dose and fraction size are important prognostic factors for survival, although to our knowledge the optimal model has not been well determined to date. The purpose of this clinical trial is to investigate the optimal radiation dose to investigate the feasibility of decreasing the total dose and increasing the fraction size with the objective of achieving a better balance between local control and severe late complications. for initial distant metastases nasopharyngeal carcinoma with definitive radiotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofraction radiation | Radiation | — | UNRESOLVED |
| Standard dose IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypofractionated dose IMRT
- description
- Patients receive hypofractionated with a low total dose radiation with induced chemotherapy and adjuvant chemotherapy.
- interventionNames
- Radiation: Hypofraction radiation
- type
- EXPERIMENTAL
- label
- Standard-dose IMRT
- description
- Patients receive standard-dose radiation therapy with induced chemotherapy and adjuvant chemotherapy..
- interventionNames
- Radiation: Standard dose IMRT
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type) Tumor staged as any T or any N with M (according to the 8th AJCC edition). 2. No pregnant female 3. Age between 18-70 4. Normal complete blood count level (hemoglobin \>10 g/dL, white blood cells ≥4000/μL, platelets ≥100 000/μL) 5. Normal hepatic functions (serum total bilirubin ≤1.6 mg/dL, serum transminase \< 2.5 times higher than upper limit) 6. Normal renal function (serum creatinine ≤1.5 mg/dL, creatinine clearance ≥60 mL/min) 7. Karnofsky performance status (KPS) score of at least 70 8. Without radiotherapy or chemotherapy 9. Patients must give signed informed consent Exclusion Criteria: 1. Other or mixed pathological type 2. age \> 70 years or \<18 years 3. Prior chemotherapy, radiation, surgical resection or target therapy of the primary tumor; 4. Significant medical or psychiatric illnesses that in the physician's judgment (uncontrolled coronary heart disease, cardiomyopathy and/or heart failure requiring hospitalization. Uncontrolled hypertension or history of myocardial infarction within one year. Uncontrolled diabetes mellitus. Acute bacterial or fungal infection requiring intravenous antibiotics; 5. Refused to sign informed consent form 6. Concurrent pregnancy or lactation 7. History of a second malignancy other than nasopharyngeal carcinoma
References
Publications (1)
- DERIVEDLiu J, Zhang B, Su Y, Qin G, Kong X, Mo Y, Zhang R, Jiang W. Hypofractionated radiotherapy compared with conventionally fractionated radiotherapy to treat initial distant metastases in nasopharyngeal carcinoma: A multicenter, prospective, randomized, phase II trial. Radiother Oncol. 2023 Oct;187:109815. doi: 10.1016/j.radonc.2023.109815. Epub 2023 Jul 20. PMID 37480994