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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expeiment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymosin a1 | Drug | All patients received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life score | EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer) core questionnaire | 1 year |
| Overall Survival | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Liu, Professor | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21847050 | Background | Detterbeck 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. | |
| 21847052 | Background | Detterbeck 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. |
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| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| hypofractionated radiotherapy | Radiation | 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. |
|
| concurrent chemoradiotherapy | Drug | All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy . |
|
| 24457243 | Background | Gao 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. |
| 24722150 | Background | Marx 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. |
| 25246487 | Background | Guerrera 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. |
| 18317070 | Background | Onuki 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. |
| 15013585 | Background | Bretti S, Berruti A, Loddo C, Sperone P, Casadio C, Tessa M, Ardissone F, Gorzegno G, Sacco M, Manzin E, Borasio P, Sannazzari GL, Maggi G, Dogliotti L; Piemonte Oncology Network. Multimodal management of stages III-IVa malignant thymoma. Lung Cancer. 2004 Apr;44(1):69-77. doi: 10.1016/j.lungcan.2003.09.022. |
| 18222230 | Background | Wright 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. |
| 24139613 | Background | Korst 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. |
| 9436540 | Background | Venuta F, Rendina EA, Pescarmona EO, De Giacomo T, Vegna ML, Fazi P, Flaishman I, Guarino E, Ricci C. Multimodality treatment of thymoma: a prospective study. Ann Thorac Surg. 1997 Dec;64(6):1585-91; discussion 1591-2. doi: 10.1016/s0003-4975(97)00629-2. |
| 11343932 | Background | Lucchi M, Mussi A, Basolo F, Ambrogi MC, Fontanini G, Angeletti CA. The multimodality treatment of thymic carcinoma. Eur J Cardiothorac Surg. 2001 May;19(5):566-9. doi: 10.1016/s1010-7940(01)00666-2. |
| 8361199 | Background | Rea F, Sartori F, Loy M, Calabro F, Fornasiero A, Daniele O, Altavilla G. Chemotherapy and operation for invasive thymoma. J Thorac Cardiovasc Surg. 1993 Sep;106(3):543-9. |
| 17410014 | Background | Yokoi K, Matsuguma H, Nakahara R, Kondo T, Kamiyama Y, Mori K, Miyazawa N. Multidisciplinary treatment for advanced invasive thymoma with cisplatin, doxorubicin, and methylprednisolone. J Thorac Oncol. 2007 Jan;2(1):73-8. doi: 10.1097/JTO.0b013e31802bafc8. |
| 17600284 | Background | Goldstein AL. History of the discovery of the thymosins. Ann N Y Acad Sci. 2007 Sep;1112:1-13. doi: 10.1196/annals.1415.045. Epub 2007 Jun 28. |
| 12860169 | Background | Garaci E, Pica F, Sinibaldi-Vallebona P, Pierimarchi P, Mastino A, Matteucci C, Rasi G. Thymosin alpha(1) in combination with cytokines and chemotherapy for the treatment of cancer. Int Immunopharmacol. 2003 Aug;3(8):1145-50. doi: 10.1016/S1567-5769(03)00053-5. |
| 27755854 | Background | Jiang J, Wang X, Tian J, Li L, Lin Q. Thymosin plus cisplatin with vinorelbine or gemcitabine for non-small cell lung cancer: A systematic review and meta-analysis of randomized controlled trials. Thorac Cancer. 2011 Nov;2(4):213-220. doi: 10.1111/j.1759-7714.2011.00057.x. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D003131 |
| Combined Modality Therapy |
| D004358 | Drug Therapy |