Reduced-dose radiotherapy guided by PET/CT for nasopharyngeal cancer

A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma

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
• Enrollment: 93 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Taizhou Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 4 sites (Taizhou, Zhejiang and 3 other locations)
• Trial ID: NCT04813705 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with confirmed nasopharyngeal squamous cell carcinoma and specific metabolic response criteria.

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.

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 performed: While similar approaches have been explored, this specific method of reduced-dose radiotherapy guided by PET/CT is relatively novel.

Eligibility 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 this trial is running

Taizhou, Zhejiang and 3 other locations

• 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

Conditions Nasopharyngeal Carcinoma