Lower-dose versus standard-dose radiation to low-risk areas in nasopharyngeal cancer
A Randomized, Open-Label, Non-Inferiority Phase III Multicenter Clinical Trial Comparing Reduced-Dose to Standard-Dose Prophylactic Irradiation for Low-Risk Clinical Target Volume (CTV) in the Treatment of Nasopharyngeal Carcinoma.
This trial will test whether giving lower radiation doses to low-risk areas can control cancer as well but cause fewer side effects in adults (18–70) with newly diagnosed, non-metastatic non-keratinizing nasopharyngeal cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Dongguan, Guangdong and 5 other locations) |
| Trial ID | NCT07201337 on ClinicalTrials.gov |
What this trial studies
This phase 3, multicenter, randomized non-inferiority trial compares reduced-dose prophylactic irradiation to standard-dose prophylactic irradiation delivered to the low-risk clinical target volume in newly diagnosed, non-metastatic, non-keratinizing nasopharyngeal carcinoma. Patients are randomized to one of the two radiation dose regimens and followed for locoregional control, survival, treatment-related toxicity, and quality of life. Key eligibility includes age 18–70, ECOG performance status 0–1, adequate hematologic, renal and hepatic function, and no prior chemotherapy, surgery (except diagnostic) or radiotherapy to the nasopharynx or neck. The trial is conducted across multiple centers in Guangdong with standardized radiation protocols to maintain consistent target delineation and dosing.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–70 with newly diagnosed, untreated, non-distant metastatic, non-keratinizing nasopharyngeal carcinoma with ECOG 0–1 and adequate organ function.
Not a fit: Patients with distant metastases, keratinizing histology, prior head/neck radiotherapy or major prior treatment, pregnancy or severe comorbidities are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, patients could maintain the same cancer control while experiencing fewer side effects and improved quality of life.
How similar studies have performed: Smaller phase II and single-center de-escalation studies have suggested maintained control with reduced toxicity, but definitive phase 3 confirmation is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; aged between 18 and 70 years; Eastern Cooperative Oncology Group performance score of 0-1; adequate hematologic function (neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥100×109/L, and hemoglobin≥ 90 g/L); adequate renal function (creatinine ≤ 1.5 upper limit of normal \[ULN\]) or calculated creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); and adequate hepatic function (serum bilirubin ≤ 2.0×ULN, and alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN). Exclusion Criteria: Previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy (except for cured basal cell carcinoma or carcinoma in situ of the cervix); lactation or pregnancy; or severe coexisting illness. \-
Where this trial is running
Dongguan, Guangdong and 5 other locations
- Dongguan People's Hospital — Dongguan, Guangdong, China (Recruiting)
- Sun yat-sen university cancer center — Guangzhou, Guangdong, China (Recruiting)
- Affiliated Cancer Hospital of Shantou University Medical College — Shantou, Guangdong, China (Recruiting)
- Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center — Shenzhen, Guangdong, China (Recruiting)
- The University of Hong Kong-Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
- Affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Hai-Qiang Mai, Ph. D.
- Email: maihq@sysucc.org.cn
- Phone: +86-020-87343643
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.