Clinical trial · Interventional
Preoperative Treatment of Patients With High Risk Thymoma
Phase II Study of Trimodality Therapy for Patients With Thymoma or Thymic Carcinoma at Significant Risk for Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase II study for patients with thymoma or thymic carcinoma thought to be at significant risk for recurrence following surgical removal. This study involves the use of combined chemotherapy and radiation therapy prior to surgery, in hopes of increasing the chances of complete resection. The chemoradiotherapy protocol is one which has been used extensively for other diseases, and the side effects are therefore well-documented. Patients with thymomas thought to be at significant risk for recurrence (by x-ray and pathology criteria) will be allowed to participate, and will undergo combined chemotherapy with radiation to the chest followed by surgical removal of the tumor and postoperative chemotherapy. The main outcome measured will be the rate of pathological complete response (e.g. no active tumor in the resected specimen) to the preoperative treatment. Patients will receive postoperative treatment based on surgical and pathologic criteria.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thymoma | Thymoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin and etoposide | Drug | — | UNRESOLVED |
| Concurrent Radiotherapy | Radiation | — | UNRESOLVED |
| Surgical Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Registration
- description
- Cisplatin, Etoposide \& concurrent radiotherapy
- interventionNames
- Drug: cisplatin and etoposide
- Radiation: Concurrent Radiotherapy
- type
- OTHER
- label
- Surgical Resection
- description
- No distant Progression post Registration Arm
- interventionNames
- Procedure: Surgical Resection
- type
- OTHER
- label
- Post Resection
- description
- Assessment post surgical procedure to determine if at higher risk of recurrence or if complete resection could not be achieved.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven thymoma or thymic carcinoma. * Invasive thymoma determined by specific radiographic criteria determined by CT scan. * Acceptable kidney, liver, bone marrow, and respiratory functions. * Karnofsy performance status greater than 80%. * Patients must have a CT of the chest with IV contrast within 60 days of enrollment. * Tumors larger than 8cm in greatest diameter on CT scan. * For tumors 5-8cm in greatest diameter on CT scan, one or more of the following radiographic criteria must also be present on IV contrast CT Scan: * Multifocal calcification * Heterogeneous appearance * Irregular of scalloped borders * Obvious great vessel invasion or encirclement Exclusion Criteria: * Considered unable to medically tolerate surgical resection at the time of initial presentation. * Radiographic evidence of stage IVA thymoma. * Pretreatment biopsy showing WHO type A thymoma unless obvious great vessel invasion/encirclement is present on CT scan. * Previous radiation therapy to the chest which would preclude the administration of radiation. * Patents receiving other investigational drugs.
References
Publications (2)
- DERIVEDKorst RJ, Bezjak A, Blackmon S, Choi N, Fidias P, Liu G, Marx A, Wright C, Mock S, Rutledge JR, Keshavjee S. Neoadjuvant chemoradiotherapy for locally advanced thymic tumors: a phase II, multi-institutional clinical trial. J Thorac Cardiovasc Surg. 2014 Jan;147(1):36-44, 46.e1. doi: 10.1016/j.jtcvs.2013.08.061. Epub 2013 Oct 15. PMID 24139613
- DERIVEDWright CD, Choi NC, Wain JC, Mathisen DJ, Lynch TJ, Fidias P. Induction chemoradiotherapy followed by resection for locally advanced Masaoka stage III and IVA thymic tumors. Ann Thorac Surg. 2008 Feb;85(2):385-9. doi: 10.1016/j.athoracsur.2007.08.051. PMID 18222230