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Clinical Trials in China / NCT04813705
Recruiting Phase 2

18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma

NCT04813705 · tracked via the Priya Life Science China tracker
Sponsor
Taizhou Hospital
Phase
Phase 2
Started
2022-01-01
Last updated
2023-02-21

Condition(s) studied

Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

Reduced doseConventional doseChemotherapy

Reduced dose: The patients with CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.

Conventional dose: The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.

Chemotherapy: The patients with stage II will receive concurrent cisplatin during Intensity modulated radiotherapy (IMRT), and stage III-IVA patients will receive platinum based induction chemotherapy every 21 days for at least two cycles followed by concurrent cisplatin during IMRT.

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Taizhou Central Hospital Taizhou Zhejiang Recruiting
Taizhou Hospital Taizhou Zhejiang Recruiting
Taizhou Cancer Hospital Taizhou Zhejiang Recruiting
Taizhou Enze Medical Center(Group) Enze Hospital Taizhou Zhejiang Recruiting

More Taizhou Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04813705 on ClinicalTrials.gov ↗ ← All trials in China