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NCT03659578·Phase 2·INTERVENTIONAL

Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Enrollment

69

Locations

1

Results

Not posted

Publications

12

Study summary

What the protocol is testing.

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.

Full detailed description

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.

Interventions

Treatment arms and agents.

DRUG

Concurrent chemotherapy

Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.

RADIATION

split-course radiotherapy

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

DRUG

thymosin alpha 1

subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.

Timeline

From registration to results.

  1. First posted

    Sep 6, 2018

  2. Study start

    Aug 9, 2018

  3. Primary completion

    Sep 30, 2021

  4. Study completion

    Sep 30, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Jan 3, 2022

Outcomes

What the study measures.

Primary outcomes

Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version)

Time frame · 1-year

Radiation-induced pneumonitis except other reasons induced pneumonia

Secondary outcomes

Total lymphocyte count

Time frame · From the beginning of CCRT until 6 months after the completion of CCRT.

C-reaction protein

Time frame · From the beginning of CCRT until 6 months after the completion of CCRT.

grade of pulmonary fibrosis (CTCAE 5.0 version)

Time frame · 1-year

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Pathologic confirmation of NSCLC. * Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * Unresectable phase IIIA-IIIC lung cancer confirmed by PET/CT, CT or MRI. * Whole lung V20\>=35% when giving 60Gy which is the minimum dose of radical irradiation. * 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: * Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ * Contraindication for chemotherapy * Malignant pleural or pericardial effusion. * Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose * Women who has the probability of pregnancy without contraception * Tendency of hemorrhage * In other clinical trials within 30 days * Addicted in drugs or alcohol, AIDS patients * Uncontrollable seizure or psychotic patients without self-control ability * Severe allergy or idiosyncrasy * Not suitable for this study judged by researchers

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China

Publications

Results and literature.

PMID 26808342Chen 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.PMID 28055103Siegel 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.PMID 26095618Mery 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.PMID 10561343Furuse 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.PMID 20108308Wang 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.PMID 21903745Curran 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.PMID 16087956Fournel 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.PMID 20351327Auperin 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.PMID 20171521Marks 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.PMID 21532501Gielda 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.PMID 19327915Spoelstra 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.PMID 23198719Dang 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.

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