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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Nasopharyngeal Carcinoma; Metastasis; Stereotactic Body Radiation Therapy
• Intervention / Treatment: Radiation: SBRT

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.

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Radiation: SBRT; SBRT for oligometastatic lesions will be assigned to those who got PR,SD after systemic treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	From date of diagnosis until the date of death from any cause	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
New Metastatic Free Survival	From date of diagnosis until the date of first documented new metastasis	up to 3 years
Adverse Event	Number of Participants with acute or late toxicities	up to 3 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): May 31, 2026
• Study Completion (Anticipated): May 31, 2026

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: NPC-SBRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No