Clinical trial · Interventional
Reducing Dose and Irradiated Volume in Cervical Prophylactic Irradiation for Nasopharyngeal Cancer
Phase 3, Prospective, Randomized, Open-Label Study on Simultaneously Reducing Both the Dose and the Irradiated Volume of Cervical Prophylactic Irradiation in Nasopharyngeal Cancer
- 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)
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
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT with reduced-dose and reduced-volume cervical prophylactic irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- The experimental arm receives IMRT to the primary tumor and involved lymph nodes, with a reduced dose and volume of cervical prophylactic irradiation.
- interventionNames
- Radiation: IMRT with reduced-dose and reduced-volume cervical prophylactic irradiation
- type
- NO_INTERVENTION
- label
- Control Group
- description
- 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.
Primary outcomes (1)
- measure
- Regional failure-free survival
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available