Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of acute pneumonia in non-small cell lung cancer with bulky tumor.
This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of radiation pneumonitis in non-small cell lung cancer with bulky tumor.
All patients received four cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each of 1 day's duration, combined with split-course thoracic radiotherapy of 51 Gy in 17 fractions or 40 Gy in 10 fractions as the first course followed by a break of four weeks. Patients without disease progression had a dose of 15 Gy in 5 fractions or 24 Gy in 6 fractions as a boost. Patients were further treated with subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation. Toxicities will be graded according to CTCAE v. 4.0.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thymosin α1 | Experimental | Patients are treated with subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concurrent chemotherapy | Drug | Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version) | Radiation-induced pneumonitis except other reasons induced pneumonia | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Total lymphocyte count | From the beginning of CCRT until 6 months after the completion of CCRT. | |
| C-reaction protein | From the beginning of CCRT until 6 months after the completion of CCRT. | |
| Measure | Description | Time Frame |
|---|---|---|
| Alpha diversity of gut microbiota as the exploratory outcome | From baseline to the end of CCRT, an average of 2 months |
Inclusion Criteria:
Pathologic confirmation of NSCLC.
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.
Previously treated with chemotherapy or treatment-naive
No previous chest radiotherapy, immunotherapy or biotherapy
Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
FEV1 >0.8 L
CB6 within normal limits
patients and their family signed the informed consents
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26808342 | Background | Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25. | |
| 28055103 | Background | Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5. |
| Label | URL |
|---|---|
| 11\. National Comprehensive Cancer Network. (NCCN) Clinical Practice Guidelines in Oncology. Small Cell Lung Cancer, Version | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077596 | Thymalfasin |
| ID | Term |
|---|---|
| D013947 | Thymosin |
| D013951 | Thymus Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| split-course radiotherapy | Radiation | Patient was administered with 51 Gy in 17 fractions or 40 Gy in 10 fractions as the first course followed by a break of four weeks. Patients without disease progression had a dose of 15 Gy in 5 fractions or 24 Gy in 6 fractions as a boost |
|
| thymosin alpha 1 | Drug | subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation. |
|
| grade of pulmonary fibrosis (CTCAE 5.0 version) |
| 1-year |
| 26095618 | Background | Mery B, Guy JB, Swalduz A, Vallard A, Guibert C, Almokhles H, Ben Mrad M, Rivoirard R, Falk AT, Fournel P, Magne N. The evolving locally-advanced non-small cell lung cancer landscape: Building on past evidence and experience. Crit Rev Oncol Hematol. 2015 Nov;96(2):319-27. doi: 10.1016/j.critrevonc.2015.05.020. Epub 2015 Jun 7. |
| 10561343 | Background | Furuse K, Fukuoka M, Kawahara M, Nishikawa H, Takada Y, Kudoh S, Katagami N, Ariyoshi Y. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 1999 Sep;17(9):2692-9. doi: 10.1200/JCO.1999.17.9.2692. |
| 20108308 | Background | Wang T, Nelson RA, Bogardus A, Grannis FW Jr. Five-year lung cancer survival: which advanced stage nonsmall cell lung cancer patients attain long-term survival? Cancer. 2010 Mar 15;116(6):1518-25. doi: 10.1002/cncr.24871. |
| 21903745 | Background | Curran WJ Jr, Paulus R, Langer CJ, Komaki R, Lee JS, Hauser S, Movsas B, Wasserman T, Rosenthal SA, Gore E, Machtay M, Sause W, Cox JD. Sequential vs. concurrent chemoradiation for stage III non-small cell lung cancer: randomized phase III trial RTOG 9410. J Natl Cancer Inst. 2011 Oct 5;103(19):1452-60. doi: 10.1093/jnci/djr325. Epub 2011 Sep 8. |
| 16087956 | Background | Fournel P, Robinet G, Thomas P, Souquet PJ, Lena H, Vergnenegre A, Delhoume JY, Le Treut J, Silvani JA, Dansin E, Bozonnat MC, Daures JP, Mornex F, Perol M; Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie. Randomized phase III trial of sequential chemoradiotherapy compared with concurrent chemoradiotherapy in locally advanced non-small-cell lung cancer: Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie NPC 95-01 Study. J Clin Oncol. 2005 Sep 1;23(25):5910-7. doi: 10.1200/JCO.2005.03.070. Epub 2005 Aug 8. |
| 20351327 | Background | Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29. |
| 20171521 | Background | Marks LB, Bentzen SM, Deasy JO, Kong FM, Bradley JD, Vogelius IS, El Naqa I, Hubbs JL, Lebesque JV, Timmerman RD, Martel MK, Jackson A. Radiation dose-volume effects in the lung. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S70-6. doi: 10.1016/j.ijrobp.2009.06.091. |
| 21532501 | Background | Gielda BT, Marsh JC, Zusag TW, Faber LP, Liptay M, Basu S, Warren WH, Fidler MJ, Batus M, Abrams RA, Bonomi P. Split-course chemoradiotherapy for locally advanced non-small cell lung cancer: a single-institution experience of 144 patients. J Thorac Oncol. 2011 Jun;6(6):1079-86. doi: 10.1097/JTO.0b013e3182199a7c. |
| 19327915 | Background | Spoelstra FO, Pantarotto JR, van Sornsen de Koste JR, Slotman BJ, Senan S. Role of adaptive radiotherapy during concomitant chemoradiotherapy for lung cancer: analysis of data from a prospective clinical trial. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1092-7. doi: 10.1016/j.ijrobp.2008.12.027. Epub 2009 Mar 26. |
| 23198719 | Background | Dang J, Li G, Ma L, Diao R, Zang S, Han C, Zhang S, Yao L. Predictors of grade >/= 2 and grade >/= 3 radiation pneumonitis in patients with locally advanced non-small cell lung cancer treated with three-dimensional conformal radiotherapy. Acta Oncol. 2013 Aug;52(6):1175-80. doi: 10.3109/0284186X.2012.747696. Epub 2012 Dec 3. |
| 24588668 | Background | Ji K, Zhao LJ, Liu WS, Liu ZY, Yuan ZY, Pang QS, Wang J, Wang P. Simultaneous integrated boost intensity-modulated radiotherapy for treatment of locally advanced non-small-cell lung cancer: a retrospective clinical study. Br J Radiol. 2014 Mar;87(1035):20130562. doi: 10.1259/bjr.20130562. Epub 2014 Jan 27. |
| 7713782 | Background | McDonald S, Rubin P, Phillips TL, Marks LB. Injury to the lung from cancer therapy: clinical syndromes, measurable endpoints, and potential scoring systems. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1187-203. doi: 10.1016/0360-3016(94)00429-O. |
| 14967431 | Background | Barthelemy-Brichant N, Bosquee L, Cataldo D, Corhay JL, Gustin M, Seidel L, Thiry A, Ghaye B, Nizet M, Albert A, Deneufbourg JM, Bartsch P, Nusgens B. Increased IL-6 and TGF-beta1 concentrations in bronchoalveolar lavage fluid associated with thoracic radiotherapy. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):758-67. doi: 10.1016/S0360-3016(03)01614-6. |
| 14751516 | Background | Trott KR, Herrmann T, Kasper M. Target cells in radiation pneumopathy. Int J Radiat Oncol Biol Phys. 2004 Feb 1;58(2):463-9. doi: 10.1016/j.ijrobp.2003.09.045. |
| 7037385 | Background | Rasmussen L, Arvin A. Chemotherapy-induced immunosuppression. Environ Health Perspect. 1982 Feb;43:21-5. doi: 10.1289/ehp.824321. |
| 1317051 | Background | Brambilla C, Romand P, Vanderkerckhove C, Moro D. [Respiratory infection and bronchial cancer]. Rev Mal Respir. 1992;9 Suppl 1:R49-52. French. |
| 9805755 | Background | Klastersky J. [The infectious complications of bronchial cancer]. Rev Mal Respir. 1998 Sep;15(4):451-9. French. |
| 24828665 | Background | Zhuang H, Yuan Z, Chang JY, Wang J, Pang Q, Zhao L, Wang P. Radiation pneumonitis in patients with non--small-cell lung cancer treated with erlotinib concurrent with thoracic radiotherapy. J Thorac Oncol. 2014 Jun;9(6):882-5. doi: 10.1097/JTO.0000000000000126. |
| 23327199 | Background | Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932. |
| 14982877 | Background | Romani L, Bistoni F, Gaziano R, Bozza S, Montagnoli C, Perruccio K, Pitzurra L, Bellocchio S, Velardi A, Rasi G, Di Francesco P, Garaci E. Thymosin alpha 1 activates dendritic cells for antifungal Th1 resistance through toll-like receptor signaling. Blood. 2004 Jun 1;103(11):4232-9. doi: 10.1182/blood-2003-11-4036. Epub 2004 Feb 24. |
| 18798500 | Background | Zheng BX, Cheng DY, Xu G, Fan LL, Yang Y, Yang W. [The prophylactic effect of thymosin alpha 1 on the acute exacerbation of chronic obstructive pulmonary disease]. Sichuan Da Xue Xue Bao Yi Xue Ban. 2008 Jul;39(4):588-90. Chinese. |
| 15364136 | Background | Zatloukal P, Petruzelka L, Zemanova M, Havel L, Janku F, Judas L, Kubik A, Krepela E, Fiala P, Pecen L. Concurrent versus sequential chemoradiotherapy with cisplatin and vinorelbine in locally advanced non-small cell lung cancer: a randomized study. Lung Cancer. 2004 Oct;46(1):87-98. doi: 10.1016/j.lungcan.2004.03.004. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |