SBRT for Oligo-metastatic Lesions After Systemic Treatmen... | NCT04351282

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

NCT04351282

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Apr 17, 2020Actual

Enrollment

43Estimated

Phase

Not Applicable

Conditions

Nasopharyngeal Carcinoma
Metastasis
Stereotactic Body Radiation Therapy

Interventions

SBRT

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Estimated

Primary Completion Date

May 31, 2026Estimated

Completion Date

May 31, 2026Estimated

First Submitted Date

Apr 2, 2020

First Submission Date that Met QC Criteria

Apr 16, 2020

First Posted Date

Apr 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2020

Last Update Posted Date

Apr 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SBRT	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SBRT	Radiation	SBRT for oligometastatic lesions will be assigned to those who got PR,SD after systemic treatment.	SBRT

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000077274	Nasopharyngeal Carcinoma
D009362	Neoplasm Metastasis

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms