Glucocorticoids Combined With Concurrent Chemoradiotherap... | NCT06730308

Studies
Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma

NCT06730308

Sponsor

Sun Yat-sen University

Status

Recruiting

Last Update Posted

Dec 12, 2024Actual

Enrollment

45Estimated

Phase

Phase 2

Conditions

Thymoma

Interventions

Radiotherapy
Concurrent chemotherapy
Methylprednisolone

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

Dec 2024

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

Nov 20, 2024Actual

Primary Completion Date

Nov 19, 2028Estimated

Completion Date

Nov 19, 2028Estimated

First Submitted Date

Dec 9, 2024

First Submission Date that Met QC Criteria

Dec 11, 2024

First Posted Date

Dec 12, 2024Actual

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 11, 2024

Last Update Posted Date

Dec 12, 2024Actual

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

This study aims to assess the efficacy of methylprednisolone combined with concurrent chemoradiotherapy in treating unresectable or recurrent thymoma.

Detailed Description

This study aims to assess the efficacy of methylprednisolone combined with concurrent chemoradiotherapy in treating unresectable or recurrent thymoma. Patients will receive hypofractionated radiotherapy with concurrent chemotherapy.

Methylprednisolone will be administered daily during radiotherapy at a dose of 2 mg/kg.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study arm	Experimental	Methylprednisolone combined with concurrent chemoradiotherapy	Radiation: Radiotherapy Drug: Concurrent chemotherapy Drug: Methylprednisolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy	Radiation	Hypofractionated radiotherapy	Study arm
Concurrent chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate	The percentage of patients who achieve complete remission or partial remission after chemoradiotherapy	1-2 months after chemoradiotherapy

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival	From the start date of initial treatment to progression, death or last follow-up	2-year
Overall survival	From the start date of initial treatment to death or to last follow-up.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed type AB or B1-3 thymoma.
Measurable Disease: Patients must have measurable disease as defined by RECIST (Response Evaluation Criteria in Solid Tumors).
Unresectable or recurrent thymoma, with the tumor confined to the chest and neck area.
Between the ages of 18 and 70 years, regardless of sex.
Eastern Cooperative Oncology Group performance status of 0 or 1.
No prior chest radiation.
Adequate organ Functions.
Written informed consent obtained.

Exclusion Criteria:

Contraindications to Methylprednisolone.
History of or Concurrent Malignancy.
Active infection, myocardial infarction within the last 6 months or symptomatic heart disease.
Pregnant or Lactating Women.
Bleeding Disorders.
Recent Participation in Other Clinical Trials.
Drug Abuse or Severe Alcoholism.
Uncontrolled Seizures or Mental Disorders.
Severe Allergies or Specific Sensitivities.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun yat-sen University Cancer Center	Recruiting	Guanzhou	Guangdong	510000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013945	Thymoma

Ancestor Terms

ID	Term
D018193	Neoplasms, Complex and Mixed
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D013953	Thymus Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011878	Radiotherapy
D008775	Methylprednisolone

Ancestor Terms

ID	Term
D013812	Therapeutics
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes

Browse Leaves

Not provided

Browse Branches

Not provided