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Radiotherapy Side EffectSBRTLCESNCT04274270

SBRT With S1 Combined With Endostar in the Treatment of Lung Cancer

A study testing Endostar in people with Radiotherapy Side Effect, run by Peking University Third Hospital at 16 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Human recombinant endostatin preclinical studies have shown that the drug can inhibit endothelial cell proliferation, angiogenesis and tumor growth, still can directly induce lung cancer cell apoptosis, multiple clinical studies in human recombinant endostatin combined with chemotherapy treatment showed good antitumor… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Radiotherapy Side Effect
What is being tested?
Endostar
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
16 sitesChina
Study dates
1 Apr 2020to 30 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Lung squamous cell carcinoma was confirmed by histopathology or cytopathology;
  • Meet AJCC(8th edition, 2018) lung cancer stage IV standard;
  • Lesions requiring SBRT;
  • Measurable lesions must have at least one evaluable lesion judged according to RECIST 1.1 standard, i.e., the longest diameter is at least 20mm);
  • Age >=18 years old;
  • KPS > = 70;
  • Life expectancy of at least 3 months;
  • Hematology, liver and kidney function and cardiopulmonary function can tolerate radiotherapy and chemotherapy.

Who cannot join

  • Lung adenocarcinoma or small cell lung cancer;
  • Previous immunotherapy;
  • Patients at risk of bleeding;
  • Patients with any other malignant tumor before or now
  • Patients diagnosed with esophagotracheal fistula,uncontrolled pleural effusion,pericardial effusion requiring repeated drainage,unhealed wounds,active gastric ulcers or fractures
  • Patients suffering from poorly controlled heart disease or clinical symptoms, such as NYHA grade II or above cardiac dysfunction;unstable angina pectoris;Myocardial infarction occurred within 1 year;supraventricular or ventricular arrhythmia needs treatment or intervention;
Show all 10Show fewer
  • Patients with known central nervous system metastases.
  • Patients with clinically suspected central nervous system metastasis must undergo enhanced CT or MRI within 28 days prior to randomization to exclude central nervous system metastasis.
  • Pregnant or breastfeeding women;Women and men who are likely to become pregnant but do not want to use appropriate contraception;
  • Other circumstances in which the investigator decides not to participate in this study.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

    Junjie Wang, Chairman, +8682264910, junjiewang_edu@sina.cn

    Fei Xu, +8618511866032, xufeibysy@163.com

  • The fifth medical center of PLA general hospital

    Beijing, Beijing Municipality, 100000

    Xuezhang Duan, director, +8613621386161, 13621386161@163.com

    Xuezhang Duan

  • Beijing Cancer Hospital

    Beijing

    Huiming Yu

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

    Wenyang Liu

  • China-Japan Friendship Hospital

    Beijing

    Meng Liu

  • Peking University International Hospital

    Beijing

    Jidong Wang

  • Dalian municipal central hospital affiliated of dalian medical university

    Dalian, Liaoning

    Nan Wang

  • Third Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000

    Liang Liu, M D, jinshatanwo@163.com

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi

    Chengjun Feng

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621000

    Xiaobo Du, MD, +8613550822229, duxiaobo2005@126.com

    Jie Li, M Med, +8615228324561, lijie.7181@163.com

  • Guangxi ruikang hospital

    Nanning, Guangxi, 530000

    ZuPing Lian, M Med

  • GEM flower hospital of Liaohe oil field Tang-Du Hospital

    Panjin, Liaoning, 124010

    Longhai Shen, M Med

    Long hai Shen, M Med

  • Hiser Medical Center of Qingdao

    Qingdao, Shandong, 266000

    Peng Liu, M Med

  • Second hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

    Xiang Song, M Med, songxianggeryuan@163.cob

    Lei Zhang, M Med

  • Tangdu hospital

    Xian, Shanxi, 710000

    DongJie He, M Med

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Qinghua Zhang

Other trials in China

About this study

Official title: Safety and Efficacy of Sequential Stereotactic Radiotherapy With S1 Combined With Endostar in the Treatment of Stage IV Lung Squamous Cell Carcinoma: Prospective, Multicenter, Exploratory Study

Human recombinant endostatin preclinical studies have shown that the drug can inhibit endothelial cell proliferation, angiogenesis and tumor growth, still can directly induce lung cancer cell apoptosis, multiple clinical studies in human recombinant endostatin combined with chemotherapy treatment showed good antitumor efficacy and good safety.S1 is an oral fluorouracil derivative and an improved preparation of the antitumor drug tegafur.Multiple clinical studies have reported that S1 alone or S1 combined with chemotherapy is effective in Non small cell lung cancer(NSCLC).Unfortunately, none of the prospective clinical studies to date have systematically validated the safety and efficacy of antiangiogenic drugs combined with chemotherapy in patients with advanced pulmonary SCC.The investigators expect that endu combined with S1 will increase the efficacy of advanced lung squamous cell carcinoma.The purpose of this study was to evaluate the objective remission rate and safety of entu combined with oral S1 in the treatment of advanced lung squamous cell carcinoma.

Read the detailed description

In this study, the investigatorse enrolled patients with advanced lung squamous cell carcinoma to explore the safety and efficacy of sequential local radiotherapy combined with endodontic therapy.Plan to enroll 60 cases.For those who meet the inclusion criteria, medical history collection, physical examination, hematological examination and general imaging examination shall be completed before inclusion.Radiotherapy was performed with a cyberknife or accelerator stereotactic radiotherapy, which lasted 3-10 days.After the end of radiotherapy,S1 60mg, BID, day 1-28, as taken orally, and repeated every 6 weeks, with concurrent Endostar therapy: 210mg was used by intravenous infusion for 7 consecutive days during each cycle of chemotherapy, and 30mg was used every 24 hours.Treatment-related toxicity, treatment response and survival were followed up during treatment.Drug treatment until the tumor progresses, or there is an intolerable treatment-related toxicity, or no tolerance to further treatment.The treatment lasts for up to 3 years with good toxicity tolerance.During the treatment, the dose of teggio and endu is not adjusted. If serious adverse reactions occur, the drug should be treated actively and delayed.If the investigator determines that the treatment-related toxicity cannot be tolerated, the treatment is discontinued.

Being tested
Endostar
Keywords
lung cancer, SBRT, s1,endostar
Medical subject headings
Radiation Injuries, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndostarDrug

    Also called S1

    Radiotherapy was performed with a cyberknife or accelerator stereotactic radiotherapy, which lasted 3-10 days.After the end of radiotherapy,S1 60mg, BID, day 1-28, as taken orally, and repeated every 6 weeks, with concurrent Endostar therapy: 210mg was used by intravenous infusion for 7 consecutive days during each cycle of chemotherapy, and 30mg was used every 24 hours.

Study groups in NCT04274270
Study groupRoleWhat they receive
experimental groupExperimentalRadiotherapy was performed with a cyberknife or accelerator stereotactic radiotherapy, which lasted 3-10 days.After the end of radiotherapy,S1 60mg, BID, day 1-28, as taken orally, and repeated every 6 weeks, with concurrent Endostar therapy: 210mg was used by intravenous infusion for 7 consecutive days during each cycle of chemotherapy, and 30mg was used every 24 hours.
Receives: Drug: Endostar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OS

    Overall survival

    Measured: 3 years

  2. PFS

    Progression-free survival

    Measured: the time interval of disease progression since the date of diagnosis

Secondary outcomes (3)

  1. LCR

    Local control rate criteria for short-term efficacy.

    Measured: 2 years

  2. Adverse reactions

    adverse events and laboratory tests were graded according to NCI CTC AE 5.0

    Measured: 2 years

  3. Qol

    Quality of life

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2020
  2. Study start1 Apr 2020 (estimated)
  3. Primary completion30 Jan 2022 (estimated)
  4. Study completion30 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Radiotherapy was performed with a cyberknife or accelerator stereotactic radiotherapy, which lasted 3-10 days.After the end of radiotherapy,S1 60mg, BID, day 1-28, as taken orally, and repeated every 6 weeks, with concurrent Endostar therapy: 210mg was used by intravenous infusion for 7 consecutive days during each cycle of chemotherapy, and 30mg was used every 24 hours.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04274270
Sponsor's protocol ID
2020-CKES-LUNG
Acronym
SBRTLCES
Status last verified
Feb 2020
First submitted
10 Feb 2020
Last updated
19 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Heist RS, Mino-Kenudson M, Sequist LV, Tammireddy S, Morrissey L, Christiani DC, Engelman JA, Iafrate AJ. FGFR1 amplification in squamous cell carcinoma of the lung. J Thorac Oncol. 2012 Dec;7(12):1775-1780. doi: 10.1097/JTO.0b013e31826aed28.

    PubMed 23154548

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Crino L, Weder W, van Meerbeeck J, Felip E; ESMO Guidelines Working Group. Early stage and locally advanced (non-metastatic) non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010 May;21 Suppl 5:v103-15. doi: 10.1093/annonc/mdq207. No abstract available.

    PubMed 20555058

  • Felip E, Stahel RA, Pavlidis N; ESMO Guidelines Task Force. ESMO Minimum Clinical Recommendations for diagnosis, treatment and follow-up of non-small-cell lung cancer (NSCLC). Ann Oncol. 2005;16 Suppl 1:i28-9. doi: 10.1093/annonc/mdi821. No abstract available.

    PubMed 15888743

  • William WN Jr, Lin HY, Lee JJ, Lippman SM, Roth JA, Kim ES. Revisiting stage IIIB and IV non-small cell lung cancer: analysis of the surveillance, epidemiology, and end results data. Chest. 2009 Sep;136(3):701-709. doi: 10.1378/chest.08-2968. Epub 2009 Mar 24.

    PubMed 19318668

  • D'Angelo SP, Pietanza MC, Johnson ML, Riely GJ, Miller VA, Sima CS, Zakowski MF, Rusch VW, Ladanyi M, Kris MG. Incidence of EGFR exon 19 deletions and L858R in tumor specimens from men and cigarette smokers with lung adenocarcinomas. J Clin Oncol. 2011 May 20;29(15):2066-70. doi: 10.1200/JCO.2010.32.6181. Epub 2011 Apr 11.

    PubMed 21482987

  • Socinski MA, Evans T, Gettinger S, Hensing TA, VanDam Sequist L, Ireland B, Stinchcombe TE. Treatment of stage IV non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e341S-e368S. doi: 10.1378/chest.12-2361.

    PubMed 23649446

  • Johnson DH, Fehrenbacher L, Novotny WF, Herbst RS, Nemunaitis JJ, Jablons DM, Langer CJ, DeVore RF 3rd, Gaudreault J, Damico LA, Holmgren E, Kabbinavar F. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol. 2004 Jun 1;22(11):2184-91. doi: 10.1200/JCO.2004.11.022.

    PubMed 15169807

  • Scagliotti G, Novello S, von Pawel J, Reck M, Pereira JR, Thomas M, Abrao Miziara JE, Balint B, De Marinis F, Keller A, Aren O, Csollak M, Albert I, Barrios CH, Grossi F, Krzakowski M, Cupit L, Cihon F, Dimatteo S, Hanna N. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol. 2010 Apr 10;28(11):1835-42. doi: 10.1200/JCO.2009.26.1321. Epub 2010 Mar 8.

    PubMed 20212250

  • Garon EB, Ciuleanu TE, Arrieta O, Prabhash K, Syrigos KN, Goksel T, Park K, Gorbunova V, Kowalyszyn RD, Pikiel J, Czyzewicz G, Orlov SV, Lewanski CR, Thomas M, Bidoli P, Dakhil S, Gans S, Kim JH, Grigorescu A, Karaseva N, Reck M, Cappuzzo F, Alexandris E, Sashegyi A, Yurasov S, Perol M. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014 Aug 23;384(9944):665-73. doi: 10.1016/S0140-6736(14)60845-X. Epub 2014 Jun 2.

    PubMed 24933332

  • Meng MB, Jiang XD, Deng L, Na FF, He JZ, Xue JX, Guo WH, Wen QL, Lan J, Mo XM, Lang JY, Lu Y. Enhanced radioresponse with a novel recombinant human endostatin protein via tumor vasculature remodeling: experimental and clinical evidence. Radiother Oncol. 2013 Jan;106(1):130-7. doi: 10.1016/j.radonc.2012.10.022. Epub 2013 Jan 23.

    PubMed 23351845

  • Masuda T, Watanabe M, Fujitaka K, Hamai K, Ishikawa N, Doi M, Kitaguchi S, Yamaguchi K, Sakamoto S, Horimasu Y, Miyamoto S, Nakashima T, Senoo T, Iwamoto H, Hamada H, Hattori N. Alternate-day administration of S-1 for elderly patients with advanced non-small-cell lung carcinoma: A prospective feasibility study. Mol Clin Oncol. 2018 Nov;9(5):539-544. doi: 10.3892/mco.2018.1705. Epub 2018 Aug 24.

    PubMed 30345049

  • Iwamoto Y, Mitsudomi T, Sakai K, Yamanaka T, Yoshioka H, Takahama M, Yoshimura M, Yoshino I, Takeda M, Sugawara S, Kawaguchi T, Takahashi T, Ohta M, Ichinose Y, Atagi S, Okada M, Saka H, Nakagawa K, Nakanishi Y, Nishio K. Randomized Phase II Study of Adjuvant Chemotherapy with Long-term S-1 versus Cisplatin+S-1 in Completely Resected Stage II-IIIA Non-Small Cell Lung Cancer. Clin Cancer Res. 2015 Dec 1;21(23):5245-52. doi: 10.1158/1078-0432.CCR-14-3160. Epub 2015 Aug 7.

    PubMed 26253869

  • Ohe Y, Ohashi Y, Kubota K, Tamura T, Nakagawa K, Negoro S, Nishiwaki Y, Saijo N, Ariyoshi Y, Fukuoka M. Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: Four-Arm Cooperative Study in Japan. Ann Oncol. 2007 Feb;18(2):317-23. doi: 10.1093/annonc/mdl377. Epub 2006 Nov 1.

    PubMed 17079694

  • Yamashita Y, Kataoka K, Ishida T, Matsuura M, Seno N, Mukaida H, Miyahara E, Miyata Y, Okita R, Shimizu K, Watari M, Okumichi T, Okada M. A feasibility study of postoperative adjuvant therapy of carboplatin and weekly paclitaxel for completely resected non-small cell lung cancer. J Thorac Oncol. 2008 Jun;3(6):612-6. doi: 10.1097/JTO.0b013e318174e05e.

    PubMed 18520800

Questions about this trial

What is this clinical trial studying?

A study testing Endostar in people with Radiotherapy Side Effect, run by Peking University Third Hospital at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04274270, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.

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