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Clinical trial

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

ID
Name
1508151-6
Description
This study is designed to investigate whether adjuvant radiochemotherapy after incomplete resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.
Trial arms
Trial start
2023-12-01
Estimated PCD
2024-12-01
Trial end
2026-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Cisplatin
25mg/m2,iv gtt,d1-3
Arms:
Radiochemotherapy
Other names:
DDP
Etoposide
75mg/m2,iv gtt,d1-3
Arms:
Radiochemotherapy
Other names:
VP-16
radiotherapy
60Gy/30Fx
Arms:
Radiochemotherapy, radiotherapy
Size
1
Primary endpoint
Progression free survival
2 years
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ESTIMATED'}}
Updated at
2023-12-05

1 organization

1 product

1 drug

1 indication

Organization
Fudan University
Drug
Cisplatin
Indication
Thymoma and Thymic Carcinoma
Product
Etoposide