A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
Who is this study for? Patients with nasopharyngeal carcinoma
What treatments are being studied? 18F-FDG PET/CT+Chemotherapy
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to explore whether 18F-FDG PET/CT guided reduced-dose radiotherapy would maintain survival outcomes in nasopharyngeal carcinoma (NPC) patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Pathology confirmed nasopharyngeal squamous cell carcinoma.
• Stage I-IVA（8thAJCC/UICC staging system).
• Aged 18-80 years.
• KPS≥70.
• Have measurable lesions on 18F-FDG PET/CT before treatment.
• HGB≥90 g/L，ANC≥1.5×109 /L，PLT≥80×109 /L.
• ALT,AST\<2.5 fold of ULN；TBIL\<2.0×ULN.
• CCR≥60ml/min or Cr\<1.5×ULN.
• Signed informed consent.
⁃ Have follow up condition.
Locations
Other Locations
China
Taizhou Cancer Hospital
RECRUITING
Taizhou
Taizhou Central Hospital
RECRUITING
Taizhou
Taizhou Enze Medical Center(Group) Enze Hospital
RECRUITING
Taizhou
Taizhou Hospital
RECRUITING
Taizhou
Contact Information
Primary
Haihua Yang, MD
yhh93181@hotmail.com
13819639006
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 93
Treatments
Experimental: Reduced dose group
The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
Active_comparator: Conventional dose group
The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.
Related Therapeutic Areas
Sponsors
Collaborators: Taizhou Enze Medical Center Group, Taizhou Cancer Hospital
Leads: Taizhou Hospital