Safety and Efficacy of SBRT in the Reirradiation for Ultr... | NCT05189054

Studies
Safety and Efficacy of SBRT in the Reirradiation for Ultra-central Thoracic Malignant Tumors

NCT05189054

Sponsor

Peking University Third Hospital

Status

Recruiting

Last Update Posted

Dec 27, 2023Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Stereotactic Body Radiation Therapy
Irradiation; Reaction
Thoracic Tumor
Recurrent Cancer

Interventions

stereotacitic body radiation therapy

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Apr 30, 2025Estimated

Completion Date

Apr 30, 2027Estimated

First Submitted Date

Dec 26, 2021

First Submission Date that Met QC Criteria

Dec 26, 2021

First Posted Date

Jan 12, 2022Actual

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

Dec 22, 2023

Last Update Posted Date

Dec 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The reirradiation of thoracic tumor is difficult. The possibility of surgery or re course radiotherapy is very small. In the NCCN guideline, only systemic treatment is recommended. However, the effective rate of systemic treatment is low. SBRT has the characteristics of high dose in tumor target area and low dose in surrounding normal tissues. In theory, SBRT is more conducive to the protection of normal tissues and can potentially be used in the salvage treatment of recurrent lesions after radiotherapy. Even so, SBRT is still controversial in the rescue treatment of recurrent lung cancer after radiotherapy, especially for "ultral-central" lesions close to mediastinal structures (such as bronchus, esophagus and large blood vessels), which have a high probability of fatal side effects. However, a few studies on the application of SBRT in the reirradiation for ultral-central lung cancer have shown acceptable safety and efficacy. Generally speaking, there are few studies on SBRT in the treatment of recurrent ultral-central tumor with limited data. The purpose of this study is to further evaluate the efficacy and toxicities of SBRT in the treatment of recurrent ultral-central tumors after radiotherapy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stereotacitic body radiation therapy	Radiation	The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Toxcicties	Adverse events of radiation of normal tissues (Including lung, trachea, bronchus, esophagus, blood vessels, ribs, spinal cord, brachial plexus).	From the beginning of the treatment to 3 years after the treatment.
Local control time	The time from the date of SBRT to the date of recurrence of the target tumor or the date of last observation.	From the beginning of the treatment to 3 years after the treatment.

Secondary Outcomes

Measure	Description	Time Frame
Overall survival time	The time from the date of SBRT to the date of death from any cause or the date of last observation.	From the beginning of the treatment to 3 years after the treatment.
Disease progression time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathological diagnosis is malignant tumor.
The location of the target lesion belongs to the ultra-central type of chest.
The target lesion had a history of radiotherapy, and the lesion diameter is ≤ 5cm.
There is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by previous treatment.
KPS>70, no serious or uncontrolled underlying diseases, such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction, and patients are expected to be tolerated by radiotherapy.

Exclusion Criteria:

Poor basic pulmonary function or symptom correlation caused by various reasons, unable to lie flat or cooperate with treatment.
The general condition is poor, and the expected survival time is less than 3 months.
Psychiatric patients or poor compliance, unable to cooperate to complete treatment.
For other reasons, the researcher believes that it is not suitable to participate in this trial.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with recurrent chest "ultral-central" malignant tumors after radiotherapy who received SBRT treatment in our department from 2022 to 2023 were expected to be enrolled.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhe Ji, M.D.	Contact	008618710002823		aschoff@163.com
Junjie Wang, M.D.	Contact	008601082265921		junjiewang_edu@sina.cn

Overall Officials

Name	Affiliation	Role
Junjie Wang, M.D.	Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital	Recruiting	Beijing	Beijing Municipality	100191	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Types

Clinical Study Report (CSR)

Time Frame

Data will be available within 6 months of the study completion.

Access Criteria

Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013899	Thoracic Neoplasms
D012008	Recurrence

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D020969	Disease Attributes
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided