Clinical trial · Interventional
Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor
Hypofractionated Radiotherapy Combined With Concurrent Weekly Chemotherapy and Thymosin α1 in Patients With Unresectable or Recurrent Thymic Epithelial Tumor: A Prospective, Single-arm Phase II Study
NCT03663764CI-TRIAL-00055480unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 phase II study was to assess the efficacy and toxicity of hypofractionated radiotherapy (HRT) combined with weekly docetaxel/platinum and thymosin α1 in patients with unresectable or recurrent thymic epithelia tumors (TETs).
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 and Thymic Carcinoma | Thymoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| concurrent chemoradiotherapy | Drug | — | UNRESOLVED |
| hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
| Thymosin a1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Expeiment
- description
- HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used. All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy . Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.
- interventionNames
- Drug: Thymosin a1
- Radiation: hypofractionated radiotherapy
- Drug: concurrent chemoradiotherapy
Primary outcomes (1)
- measure
- Progression-Free Survival
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- Quality of Life score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic confirmation of thymoma, thymic carcinoma or thymic endocrine tumors. * Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Unresectable disease or recurrent intrathoracic disease which could be encompassed within radiation fields. * White blood cell count ≥4×109 /L, neutrophile granulocyte count≥1.5×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN. * FEV1 \>0.8 L * CB6 within normal limits * Patients and their family signed the informed consents Exclusion Criteria: * Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ. * Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia). * Malignant pleural effusion or pericardial effusion. * Weight loss \>10% within the past 3 months. * Recruited in other clinical trials within 30 days * Drug addiction, long-term alcohol abuse and AIDS patients. * Uncontrollable epileptic attack or psychotic patients without self-control ability. * Severe allergy or idiosyncrasy. * Not suitable for this study judged by researchers.
References
Publications (16)
- BACKGROUNDDetterbeck F, Youssef S, Ruffini E, Okumura M. A review of prognostic factors in thymic malignancies. J Thorac Oncol. 2011 Jul;6(7 Suppl 3):S1698-704. doi: 10.1097/JTO.0b013e31821e7b12. No abstract available. PMID 21847050
- BACKGROUNDDetterbeck FC, Nicholson AG, Kondo K, Van Schil P, Moran C. The Masaoka-Koga stage classification for thymic malignancies: clarification and definition of terms. J Thorac Oncol. 2011 Jul;6(7 Suppl 3):S1710-6. doi: 10.1097/JTO.0b013e31821e8cff. No abstract available. PMID 21847052
- BACKGROUNDGao L, Wang C, Fang W, Zhang J, Lv C, Fu S. Outcome of multimodality treatment for 188 cases of type B3 thymoma. J Thorac Oncol. 2013 Oct;8(10):1329-34. doi: 10.1097/JTO.0b013e31829ceb50. PMID 24457243
- BACKGROUNDMarx A, Strobel P, Badve SS, Chalabreysse L, Chan JK, Chen G, de Leval L, Detterbeck F, Girard N, Huang J, Kurrer MO, Lauriola L, Marino M, Matsuno Y, Molina TJ, Mukai K, Nicholson AG, Nonaka D, Rieker R, Rosai J, Ruffini E, Travis WD. ITMIG consensus statement on the use of the WHO histological classification of thymoma and thymic carcinoma: refined definitions, histological criteria, and reporting. J Thorac Oncol. 2014 May;9(5):596-611. doi: 10.1097/JTO.0000000000000154. PMID 24722150
- BACKGROUNDGuerrera F, Rendina EA, Venuta F, Margaritora S, Ciccone AM, Novellis P, Novero D, Anile M, Bora G, Rena O, Casadio C, Mussi A, Evangelista A, Ruffini E, Lucchi M, Filosso PL. Does the World Health Organization histological classification predict outcomes after thymomectomy? Results of a multicentre study on 750 patients. Eur J Cardiothorac Surg. 2015 Jul;48(1):48-54. doi: 10.1093/ejcts/ezu368. Epub 2014 Sep 21. PMID 25246487
- BACKGROUNDOnuki T, Ishikawa S, Yamamoto T, Ito H, Sakai M, Onizuka M, Sakakibara Y, Iijima T, Noguchi M, Ohara K. Pathologic radioresponse of preoperatively irradiated invasive thymomas. J Thorac Oncol. 2008 Mar;3(3):270-6. doi: 10.1097/JTO.0b013e3181653c8c.