SBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma

N/ANot Yet RecruitingNCT04351282

Fudan University43 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasopharyngeal Carcinoma Metastasis Stereotactic Body Radiation Therapy

Interventions

SBRTRADIATION

SBRT for oligometastatic lesions will be assigned to those who got PR,SD after systemic treatment.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Overall survival

From date of diagnosis until the date of death from any cause

Time frame: up to 3 years

Secondary Outcomes

Progress free survival

From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first

Time frame: up to 3 years

Previous Metastatic Progression Free Survival

From date of diagnosis until the date of first documented previous metastatic progression or date of death from any cause, whichever came first

Time frame: up to 3 years

New Metastatic Free Survival

From date of diagnosis until the date of first documented new metastasis

Time frame: up to 3 years

Adverse Event

Number of Participants with acute or late toxicities

Time frame: up to 3 years

Data from ClinicalTrials.gov

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