Clinical trial NCT04351282: SBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma
Official title: SBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Metastasis
Stereotactic Body Radiation Therapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary metastatic NPC patients received chemotherapy± immunotherapy, radiation for primary tumors and SBRT for metastatic lesions.

Detailed description: The eligible patients will receive 4-6 cycles chemotherapy±immunotherapy and radical radiotherapy for nasopharyngeal tumors. Then, SBRT for oligometastatic lesions will be assigned to eligible patients. The efficacy and side-effect will be evaluated and analyzed. The relation of liquid biopsy data with treatment outcome（such as EBV DNA, CTCs, CTC subtype，PD-L1 and so on）will be valued.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: up to 3 years
Secondary outcomes:
measure: Progress free survival
timeFrame: up to 3 years
measure: Previous Metastatic Progression Free Survival
timeFrame: up to 3 years
measure: New Metastatic Free Survival
timeFrame: up to 3 years
measure: Adverse Event
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: