Status:
NOT_YET_RECRUITING
SBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma
Lead Sponsor:
Fudan University
Conditions:
Nasopharyngeal Carcinoma
Metastasis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04351282
Start Date
June 1 2020
End Date
May 31 2026
Last Update
April 17 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032