Reduced-dose radiotherapy guided by PET/CT for nasopharyngeal cancer
Official title: A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
Run by Taizhou Hospital · NCT04813705 · Data updated 2026-11-12
This study is testing if giving a lower dose of radiation therapy, guided by special imaging, can still help people with nasopharyngeal cancer live longer while causing fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 93 (estimated) |
| Sponsor | Taizhou Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 4 sites (Taizhou, Zhejiang and 3 other locations) |
| Status | Recruiting |
| Started | January 1, 2022 |
| Main results expected | June 30, 2024 |
| Study ends | June 30, 2029 |
| Registry record updated | February 21, 2023 |
| Trial ID | NCT04813705 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 with confirmed nasopharyngeal squamous cell carcinoma and specific metabolic response criteria.
✕Probably not a fit
Patients with a history of prior malignancies, severe organ dysfunction, or those outside the age range may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of 18F-FDG PET/CT guided reduced-dose radiotherapy in maintaining survival outcomes for patients with nasopharyngeal carcinoma (NPC). Patients with a complete metabolic response or significant partial metabolic response will receive a lower dose of intensity modulated radiation therapy (IMRT), while those with lesser responses will receive the conventional dose. The aim is to determine if reduced dosing can be as effective as standard treatment while minimizing side effects. The study will enroll patients aged 18-80 with confirmed NPC and measurable lesions.
Why it matters
Potential benefit: If successful, this approach could lead to effective treatment with fewer side effects for patients with nasopharyngeal carcinoma.
How similar studies have gone: While similar approaches have been explored, this specific method of reduced-dose radiotherapy guided by PET/CT is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pathology confirmed nasopharyngeal squamous cell carcinoma. 2. Stage I-IVA(8thAJCC/UICC staging system). 3. Aged 18-80 years. 4. KPS≥70. 5. Have measurable lesions on 18F-FDG PET/CT before treatment. 6. HGB≥90 g/L,ANC≥1.5×109 /L,PLT≥80×109 /L. 7. ALT,AST\<2.5 fold of ULN;TBIL\<2.0×ULN. 8. CCR≥60ml/min or Cr\<1.5×ULN. 9. Signed informed consent. 10. Have follow up condition. Exclusion Criteria: 1. Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ). 2. Age \<18 or \>80years. 3. Pregnancy or lactation. 4. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). 5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. 6. With sever infection and internal disease. 7. Major organ dysfunction, such as decompensated cardiopulmonary, kidney, liver failure, cannot tolerate surgical treatment.
Where it's running
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Taizhou Central Hospital
Taizhou, Zhejiang, China Recruiting -
Taizhou Hospital
Taizhou, Zhejiang, China Recruiting -
Taizhou Cancer Hospital
Taizhou, Zhejiang, China Recruiting -
Taizhou Enze Medical Center(Group) Enze Hospital
Taizhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Haihua Yang, MD — Taizhou Enze Medical Center Group
- Study coordinator: Haihua Yang, MD
- Email: yhh93181@hotmail.com
- Phone: 13819639006
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.