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

Fudan University

Status: Not yet enrolling

Conditions: Stereotactic Body Radiation Therapy; Metastasis; Nasopharyngeal Carcinoma

Treatments: Radiation: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT04351282

NPC-SBRT

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

SBRT

Experimental group

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.

Treatment:

Radiation: SBRT