Clinical trial · Interventional
18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
NCT04813705CI-TRIAL-00064074recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Conventional dose | Radiation | — | UNRESOLVED |
| Reduced dose | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Reduced dose group
- description
- The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
- interventionNames
- Radiation: Reduced dose
- Drug: Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Conventional dose group
- description
- The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.
- interventionNames
- Radiation: Conventional dose
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Local-regional recurrence free survival (LRFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.