Adjuvant Treatment for Incomplete Resection Thymoma or Th... | NCT02633514

Studies
Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

NCT02633514

Sponsor

Fudan University

Status

Withdrawn

Last Update Posted

Apr 27, 2026Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Thymoma and Thymic Carcinoma

Interventions

Cisplatin
Etoposide
radiotherapy

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 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients enrolled

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Dec 15, 2015

First Submission Date that Met QC Criteria

Dec 15, 2015

First Posted Date

Dec 17, 2015Estimated

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 22, 2026

Last Update Posted Date

Apr 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 is designed to investigate whether adjuvant radiochemotherapy after incomplete resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.

Detailed Description

The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with thymoma or thymic carcinoma.However,whether patients with thymoma or thymic carcinoma could benefit from adjuvant radiochemotherapy after incomplete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiochemotherapy after incomplete resection can improve survival for thymoma or thymic carcinoma.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiochemotherapy	Experimental	adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)	Drug: Cisplatin Drug: Etoposide Radiation: radiotherapy
radiotherapy	Sham Comparator	adjuvant radiotherapy after incomplete resection: Radiotherapy (60Gy / 30FX)	Radiation: radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cisplatin	Drug	25mg/m2,iv gtt,d1-3	Radiochemotherapy	DDP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival	from registration to disease progression or death.	2 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	from registration to death as a result of any cause	2 years
Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0	Assessed by CTCAE v4.0

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18~75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed ; incomplete resection (R1 or R2);have adequate bone marrow, hepatic, and renal function;Patients receive incomplete resection within 3 months; Written informed consent.

Exclusion Criteria:

Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.

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

Name	Affiliation	Role
Kailiang Wu, MD. PhD	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kailiang Wu		Shanghai	Shanghai Municipality	20032	China

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
D002945	Cisplatin
D005047	Etoposide
D011878	Radiotherapy

Ancestor Terms

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

Browse Leaves

Not provided

Browse Branches

Not provided