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

Not Applicable

Not yet recruiting

• Conditions: Nasopharyngeal Carcinoma; Metastasis; Stereotactic Body Radiation Therapy
• Interventions: Radiation: SBRT

• Registration Number: NCT04351282
• Lead Sponsor: Fudan University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-16
• Last Update Submitted: 2020-04-16
• Study First Posted: 2020-04-17
• Last Update Posted: 2020-04-17
• Study Start: 2020-06-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 43

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT	SBRT	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	up to 3 years	From date of diagnosis until the date of death from any cause

Secondary Outcome Measures

Name	Time	Method
Progress free survival	up to 3 years	From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first
New Metastatic Free Survival	up to 3 years	From date of diagnosis until the date of first documented new metastasis
Previous Metastatic Progression Free Survival	up to 3 years	From date of diagnosis until the date of first documented previous metastatic progression or date of death from any cause, whichever came first
Adverse Event	up to 3 years	Number of Participants with acute or late toxicities

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China