Hypofractionated Chemoradiotherapy and Thymosin α1 in Unresectable or Recurrent Thymic Epithelial Tumor

Thymoma and Thymic Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03663764
• Other study ID #: GASTO-1042
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 13, 2018
• Est. completion date: August 2023

Study information

• Verified date: November 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thymoma
• Thymoma and Thymic Carcinoma
• Thymus Neoplasms

Intervention

Drug:
• Thymosin a1
All patients received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.

Radiation:
• hypofractionated radiotherapy
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.

Drug:
• concurrent chemoradiotherapy
All patients received weekly docetaxel(25mg/?) and nedaplatin or cisplatin (25mg/?), each of 1 day's duration, concurrently with hypofractionated radiotherapy .

Locations

Country	Name	City	State
China	Sun yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (16)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Erratum in: J Thorac Oncol. 2014 Nov;9(11):1719. — View Citation

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. Review. — View Citation

Goldstein AL. History of the discovery of the thymosins. Ann N Y Acad Sci. 2007 Sep;1112:1-13. Epub 2007 Jun 28. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Marx A, Ströbel 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. — View Citation

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. — View Citation

Rea F, Sartori F, Loy M, Calabrò F, Fornasiero A, Daniele O, Altavilla G. Chemotherapy and operation for invasive thymoma. J Thorac Cardiovasc Surg. 1993 Sep;106(3):543-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival		2 years
Secondary	Quality of Life score	EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer) core questionnaire	1 year
Secondary	Overall Survival		2 years