Back to resultsSBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma, Metastasis, Stereotactic Body Radiation Therapy
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SBRT
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
Eligibility Criteria
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.
Sites / Locations
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SBRT
Arm 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.
Outcomes
Primary Outcome Measures
Overall survival
From date of diagnosis until the date of death from any cause
Secondary Outcome Measures
Progress free survival
From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first
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
New Metastatic Free Survival
From date of diagnosis until the date of first documented new metastasis
Adverse Event
Number of Participants with acute or late toxicities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04351282
Brief Title
SBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma
Official Title
SBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, Metastasis, Stereotactic Body Radiation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SBRT
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
SBRT for oligometastatic lesions will be assigned to those who got PR,SD after systemic treatment.
Primary Outcome Measure Information:
Title
Overall survival
Description
From date of diagnosis until the date of death from any cause
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Progress free survival
Description
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
Title
Previous Metastatic Progression Free Survival
Description
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
Title
New Metastatic Free Survival
Description
From date of diagnosis until the date of first documented new metastasis
Time Frame
up to 3 years
Title
Adverse Event
Description
Number of Participants with acute or late toxicities
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
SBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma
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