Clinical trial · Interventional
SBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma
NCT04351282CI-TRIAL-00044714unknownN/AClinicalTrials.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)
Primary metastatic NPC patients received chemotherapy± immunotherapy, radiation for primary tumors and SBRT for metastatic lesions.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastasis | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stereotactic Body Radiation Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT
- description
- 4-6 cycles of chemotherapy±immunotherapy and radical radiotherapy for nasopharyngeal tumors were given. SBRT for oligometastatic lesions will be assigned to those who got PR,SD after systemic treatment.
- interventionNames
- Radiation: SBRT
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- up to 3 years
- description
- From date of diagnosis until the date of death from any cause
Secondary outcomes (4)
- measure
- Progress free survival
- timeFrame
- up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically conformed initial metastatic non-keratinizing nasopharyngeal carcinoma (according to the 8th edition of AJCC/UICC stage system) and no PD was observed in eligible patients after comprehensive treatment (chemotherapy±immunotherapy+radiotherapy to primary tumor). Then, the metastic lesions were PR/SD, and met the following requirement: the metastatic lesions ≤5 and metastatic organs ≤2, no more than 3 metastastic lesions for a single organ (diameter ≤ 5cm) * age 18-70 years old * Karnofsky scores ≥70 * Estimated life ≥ 6 months * Adequate organ function including the following: Absolute neutrophil count (ANC) \>= 2.0 \* 109/l; Platelets count \>= 100 \* 109/l ;Hemoglobin \>= 90 g/dl; Creatinine clearance \>= 60 ml/min; For patients without liver metastasis, AST and ALT \<= 1.5 times institutional upper limit of normal (ULN), Total bilirubin \<= 1.5 times institutional ULN; For patients with liver metastasis, AST and ALT \<= 3 times institutional upper limit of normal (ULN), Total bilirubin \<= 3 times institutional ULN, with normal coagulation function, child-pugh grade A or B, normal liver tissue volume \>700 mL * Signed written informed consent Exclusion Criteria: * Patients who achieve complete remission after comprehensive treatment * Pathology confirmed as second primary tumor * Received radiotherapy at the corresponding site before, and overlapped with the site of this radiotherapy * Femoral bone metastasis * With serious medical complications and contraindications of radiotherapy * With uncontrollable malignant pleural effusion * Positive pregnancy test for women of childbearing age or lactating women * Uncontrolled or active infections, such as immunodeficiency or HIV infection * Active mental disorder or other mental disorder that affects the patient's ability to sign informed consent and understanding.
References
Publications (0)
Data not yet available
No reference posted for this study.