Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

A Randomized Phase III Study of Adjuvant Radiotherapy Versus Adjuvant Radiochemotherapy in Patients With Incomplete ResectionThymoma or Thymic Carcinoma

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02633514

Enrollment

Registered

2015-12-17

Start date

2023-12-01

Completion date

2026-12-01

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thymoma and Thymic Carcinoma

Keywords

thymoma, thymic carcinoma, adjuvant radiotherapy, adjuvant radiochemotherapy, incomplete resection

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.

Interventions

DRUGCisplatin

25mg/m2,iv gtt,d1-3

DRUGEtoposide

75mg/m2,iv gtt,d1-3

RADIATIONradiotherapy

60Gy/30Fx

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

PRINCIPAL_INVESTIGATORKailiang Wu, MD. PhD

Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026