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

Sponsor

Fudan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04351282

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma Metastasis Stereotactic Body Radiation Therapy	Radiation: SBRT	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

May 31, 2026

Anticipated Study Completion Date :

May 31, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Overall survival [up to 3 years]
From date of diagnosis until the date of death from any cause

Secondary Outcome Measures

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
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
New Metastatic Free Survival [up to 3 years]
From date of diagnosis until the date of first documented new metastasis
Adverse Event [up to 3 years]
Number of Participants with acute or late toxicities

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiayun He, MD, Professor, Fudan University

ClinicalTrials.gov Identifier:

NCT04351282

Other Study ID Numbers:

NPC-SBRT

First Posted:

Apr 17, 2020

Last Update Posted:

Apr 17, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Nasopharyngeal Carcinoma

Study Results

No Results Posted as of Apr 17, 2020