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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04351282
• Other study ID #: NPC-SBRT
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 43
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Metastasis
• Nasopharyngeal Carcinoma
• Stereotactic Body Radiation Therapy

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	From date of diagnosis until the date of death from any cause	up to 3 years
Secondary	Progress free survival	From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first	up to 3 years
Secondary	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	up to 3 years
Secondary	New Metastatic Free Survival	From date of diagnosis until the date of first documented new metastasis	up to 3 years
Secondary	Adverse Event	Number of Participants with acute or late toxicities	up to 3 years