Geometric expansion for radiation treatment in nasopharyngeal carcinoma
CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma: A Prospective, Multi-center, Randomized Controlled Phase III Clinical Study
This study is testing a new way of targeting radiation treatment for patients with nasopharyngeal cancer to see if it works better and is safer for healthy tissues compared to the standard method.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 474 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fujian Cancer Hospital Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06095154 on ClinicalTrials.gov |
What this trial studies
This phase III clinical trial evaluates the efficacy and safety of modified intensity-modulated radiation therapy (IMRT) for newly diagnosed nasopharyngeal carcinoma patients without distant metastasis. Patients will be randomly assigned to receive either a geometric expansion-based delineation of the clinical target volume (CTV) or a standard approach based on established guidelines. The trial aims to determine if the geometric expansion method can provide effective treatment outcomes while potentially reducing radiation exposure to surrounding healthy tissues. The study will involve multiple centers and will adhere to international guidelines for target area definitions.
Who should consider this trial
Good fit: Ideal candidates include patients with pathologically confirmed nasopharyngeal carcinoma who have no distant metastasis and an ECOG score of 0 or 1.
Not a fit: Patients with disease progression during IMRT or those with serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced side effects for patients with nasopharyngeal carcinoma.
How similar studies have performed: While similar approaches have been explored, this specific geometric expansion method in the context of nasopharyngeal carcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Fuzhou, Fujian
- Fujian Cancer hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Shaojun Lin, DR
- Email: linshaojun@yeah.net
- Phone: 13860603879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.