Actively Recruiting
A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
Led by Taizhou Hospital · Updated on 2023-02-21
93
Participants Needed
4
Research Sites
260 weeks
Total Duration
On this page
Sponsors
T
Taizhou Hospital
Lead Sponsor
T
Taizhou Enze Medical Center Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether using 18F-FDG PET/CT scans to guide reduced-dose radiotherapy can maintain survival outcomes in patients with nasopharyngeal carcinoma (NPC). This phase II study focuses on patients with NPC stages I to IVA and investigates the effectiveness of adjusting radiation doses based on metabolic responses during treatment. Patients receive intensity modulated radiation therapy (IMRT) with two possible dosing plans depending on their metabolic response at the 25th radiation fraction. Those achieving complete metabolic response (CMR) or over 70% partial metabolic response (PMR) receive a reduced dose of 63.6 Gy delivered in 30 fractions, while others receive the conventional dose of 70 Gy in 33 fractions. Chemotherapy is also administered based on disease stage, with stage II patients receiving concurrent cisplatin during IMRT, and stage III-IVA patients receiving platinum-based induction chemotherapy followed by cisplatin concurrent with IMRT. Participants undergo regular imaging with 18F-FDG PET/CT to measure metabolic response, alongside clinical assessments of survival and complications. The primary outcome is local-regional recurrence-free survival at 5 years, with secondary outcomes including overall survival, progression-free survival, distant metastasis-free survival, treatment-related complications, and overall response rate measured over up to 5 years. The study duration and follow-up are designed to evaluate both short-term and long-term effects of the radiotherapy dosing strategies.
CONDITIONS
Brief Title
18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathology confirmed nasopharyngeal squamous cell carcinoma
- Stage I-IVA (8th AJCC/UICC staging system)
- Aged 18-80 years
- Karnofsky Performance Status (KPS) 70 or higher
- Measurable lesions on 18F-FDG PET/CT before treatment
- Hemoglobin (HGB) 90 g/L or higher, absolute neutrophil count (ANC) 1.5 x10^9 /L or higher, platelet count (PLT) 80 x10^9 /L or higher
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5 times upper limit of normal (ULN); total bilirubin (TBIL) less than 2.0 times ULN
- Creatinine clearance (CCR) 60 ml/min or higher or creatinine less than 1.5 times ULN
- Signed informed consent
- Ability to comply with follow-up requirements
You will not qualify if you...
- History of past malignancies (except stage I non-melanoma skin cancer or cervical carcinoma in situ)
- Age under 18 or over 80 years
- Pregnancy or lactation
- Previous radiotherapy (except for non-melanomatous skin cancers outside intended treatment area)
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or lymph nodes
- Severe infections or internal diseases
- Major organ dysfunction such as decompensated heart, lung, kidney, or liver failure making surgery intolerable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 to 7 weeks depending on assigned radiation dose
Participants receive intensity modulated radiation therapy (IMRT) with either a reduced dose of 63.6 Gy over 30 fractions or a conventional dose of 70 Gy over 33 fractions based on metabolic response at the 25th fraction. Some participants also receive chemotherapy depending on their cancer stage, including concurrent cisplatin during IMRT or induction chemotherapy followed by cisplatin.
Daily visits for radiation therapy sessions, with additional visits for chemotherapy as scheduled
Duration - Up to 5 years
Participants are monitored for treatment response and potential complications for up to 5 years after treatment completion, including assessments of survival and recurrence.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 4 locations
1
Taizhou Central Hospital
Taizhou, Zhejiang, China, 317000
Actively Recruiting
2
Taizhou Hospital
Taizhou, Zhejiang, China, 317000
Actively Recruiting
3
Taizhou Cancer Hospital
Taizhou, Zhejiang, China, 317500
Actively Recruiting
4
Taizhou Enze Medical Center(Group) Enze Hospital
Taizhou, Zhejiang, China, 318050
Actively Recruiting
Research Team
H
Haihua Yang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here