Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

Fudan University

Status and phase: Enrolling; Phase 3

Conditions: Thymoma and Thymic Carcinoma

Treatments: Drug: Etoposide; Drug: Cisplatin; Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02633514

1508151-6

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 estimated patient

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Radiochemotherapy

Experimental group

Description:

adjuvant radiochemotherapy after incomplete resection: Cisplatin + Etoposide + Radiotherapy (60Gy / 30FX)

Treatment:

Radiation: radiotherapy

Drug: Cisplatin

Drug: Etoposide

radiotherapy

Sham Comparator group

Description:

adjuvant radiotherapy after incomplete resection: Radiotherapy (60Gy / 30FX)

Treatment:

Radiation: radiotherapy