Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

Phase 3

Recruiting

• Conditions: Thymoma and Thymic Carcinoma
• Interventions: Drug: Cisplatin; Drug: Etoposide; Radiation: radiotherapy

• Registration Number: NCT02633514
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-17
• Status Verified: 2023-12
• Study Start: 2023-12-01
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-05
• Primary Completion: 2024-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiochemotherapy	Etoposide	adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)
Radiochemotherapy	radiotherapy	adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)
radiotherapy	radiotherapy	adjuvant radiotherapy after incomplete resection: Radiotherapy (60Gy / 30FX)
Radiochemotherapy	Cisplatin	adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)

Primary Outcome Measures

Name	Time	Method
Progression free survival	2 years	from registration to disease progression or death.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kailiang Wu; 🇨🇳 Shanghai, Shanghai, China