Status:
RECRUITING
18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
Lead Sponsor:
Taizhou Hospital
Collaborating Sponsors:
Taizhou Enze Medical Center Group
Taizhou Cancer Hospital
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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.
Detailed Description
Enrolled patients with complete metabolic response (CMR) and more than 70% partial metabolic response (PMR) according to PERCIST criteria at the 25th fraction will receive intensity modulated radiatio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ).
- Age \<18 or \>80years.
- Pregnancy or lactation.
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- With sever infection and internal disease.
- Major organ dysfunction, such as decompensated cardiopulmonary, kidney, liver failure, cannot tolerate surgical treatment.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT04813705
Start Date
January 1 2022
End Date
June 30 2029
Last Update
February 21 2023
Active Locations (4)
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1
Taizhou Central Hospital
Taizhou, Zhejiang, China, 317000
2
Taizhou Hospital
Taizhou, Zhejiang, China, 317000
3
Taizhou Cancer Hospital
Taizhou, Zhejiang, China, 317500
4
Taizhou Enze Medical Center(Group) Enze Hospital
Taizhou, Zhejiang, China, 318050