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Lung CancerPhase 3LCANNCT01980849

Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer

A Phase 3 study testing Nadroparin, long term and Nadroparin: short-term in people with Lung Cancer, run by Shengqing Li at 24 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To compare the efficacy and safety of prophylaxis of venous thromboembolism by Nadroparin during hospitalization to long-term usage in patients with advanced lung cancer treated by chemotherapy and/or radiotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Cancer
What is being tested?
Nadroparin, long term and Nadroparin: short-term
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
24 sitesChina
Study dates
Nov 2013to Nov 2016
Phase
Phase 3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stage Ⅲ B and Ⅳ non-small cell lung cancer patients and inoperable small cell lung cancer patients
  • Performance status score ≤ 2
  • Chest CT with measurable lesions

Who cannot join

  • Examination revealed any part of venous thromboembolism
  • Chemotherapy regimens containing bevacizumab or Endostar
  • Severe coagulopathy
  • Active bleeding within two weeks

Trial locations and contacts

24 sites in 1 country.

Shengqing Li, MD, PhD contact

+86-29-84771132

24 sites in 1 country

China24 sites, 24 recruiting

  • The Department of Pulmonary and Critical Care Medicine,Central Hospital

    Baoji, Shaanxi, 721008

    Zhengxia Wu, MD, 13891731289, Wzx1289@163.com

    Zhengxia Wu, MD

    Recruiting

  • The Department of Oncology，Cancer Hospital

    Baotou, Inner Mongolia, 014030

    Jie Li, MD, 13847293318, 2469931063@qq.com

    Jie Li, MD

    Recruiting

  • The Department of Oncology，Northern Hospital

    Baotou, Inner Mongolia, 150200

    Fengyun Wang, MD, 15047243095, wfy2826@163.com

    Fengyun Wang, MD

    Recruiting

  • The Department of Lung oncology，Tumor Hospital

    Chengdu, Sichuan, 610041

    Ping Yu, MD, 13881864070, yuping862@126.com

    Ping Yu, MD

    Recruiting

  • The Department of Oncology，People's Hospital

    Chengdu, Sichuan, 610072

    Haitao Lan, MD, 18981838376, lanht@sina.com

    Haitao Lan, MD

    Recruiting

  • The Department of Oncology，Southwest Hospital

    Chongqing, Chongqing Municipality, 400038

    Zhihua Ruan, MD, 13883933815, rzh1234@163.com

    Zhihua Ruan, MD

    Recruiting

  • The Department of Pulmonary and Critical Care Medicine,Southwest Hospital

    Chongqing, Chongqing Municipality, 400038

    Wei Xiong, MD, 13512345225, xiongwei64@126.com

    Wei Xiong, MD

    Recruiting

  • The Department of Oncology，Ohtsubo Hospital

    Chongqing, Chongqing Municipality, 400042

    Xueqin Yang, MD, 15923366936, yxq92@163.com

    Xueqin Yang, MD

    Recruiting

  • The Department of Oncology，Fuling Central Hospital

    Chongqing, Chongqing Municipality, 408000

    Qi Zhou, MD, 18996706515, qizhou112@163.com

    Qi Zhou, MD

    Recruiting

  • The Department of Oncology，Inner Mongolia Autonomous Region Hospital

    Hohhot, Inner Mongolia, 010017

    Cuiying Zhang, MD, 13947119586, cenyao_2006@126.com

    Cuiying Zhang, MD

    Recruiting

  • The Department of Oncology，Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Xiang Song, MD, 13803436909, songxiangeryuan@163.com

    Xiang Song, MD

    Recruiting

  • The Department of Oncology，First Affiliated Hospital of Medical University

    Ürümqi, Xinjiang, 830054

    Yiming Reheman, MD, 15909002857, 42113739@qq.com

    Yiming Reheman, MD

    Recruiting

  • The Department of Pulmonary and Critical Care Medicine,First Affiliated Hospital of Medical University

    Ürümqi, Xinjiang, 830054

    Kegang Jiao, MD, 13999828305, kateone@sohu.com

    Kegang Jiao, MD

    Recruiting

  • The Department of Pulmonary and Critical Care Medicine,Second People's Hospital

    Xi'an, Shaanxi, 710005

    Zhangqin Chen, MD, 18991211556, 1191846052@qq.com

    Zhangqin Chen, MD

    Recruiting

  • The Department of Pulmonary and Critical Care Medicine, Second Affiliated Hospital of Jiaotong University

    Xi'an, Shaanxi, 710032

    Manxiang Li, MD, PhD, 15129312682, Manxiangli@hotmail.com

    Manxiang Li, MD, PhD

    Recruiting

  • The Department of Pulmonary and Critical Care Medicine, Tangdu Hospital

    Xi'an, Shaanxi, 710032

    Yonghong Xie, MD, PhD, +86-29-84777725, xieyh65@yahoo.com.cn

    Yonghong Xie, MD, PhD

    Recruiting

  • The Department of Pulmonary and Critical Care Medicine, Xijing Hospital

    Xi'an, Shaanxi, 710032

    Xuemin Yang, MD, +86-29-84775237, yangxuemin0622@163.com

    Xuemin Yang, MD

    Recruiting

  • The Department of Oncology，First Affiliated Hospital of Jiaotong University

    Xi'an, Shaanxi, 710061

    Yu Yao, MD, 13572101611, 13572101611@163.com

    Yu Yao, MD

    Recruiting

  • The Department of Oncology，Central Hospital

    Xinxiang, Henan, 453000

    Guifang Zhang, MD, 15637359110, xxchzhangguifang@126.com

    Guifang Zhang, MD

    Recruiting

  • The Department of Oncology，Yan'an University Hospital

    Yan’an, Shaanxi, 716000

    Hong Zhao, MD, 18809111001, YDFYzhaohon@163.com

    Hong Zhao, MD

    Recruiting

  • The Department of Pulmonary and Critical Care Medicine,Medical University General Hospital cardiovascular and cerebrovascular disease hospital

    Yinchuan, Ningxia, 750002

    Mei Yin, MD, 13014292909, dmeiyin@163.com

    Mei Yin, MD

    Recruiting

  • The Department of Oncology，People's Hospital

    Zhengzhou, Henan, 450003

    Zhifen Luo, MD, 13783526222, luozhifen123@126.com

    Zhifen Luo, MD

    Recruiting

  • The Department of Pulmonary and Critical Care Medicine,Cancer Hospital

    Zhengzhou, Henan, 450008

    Yanqiu Zhao, MD, 13938252350, 13938252350@163.com

    Yanqiu Zhao, MD

    Recruiting

  • The Department of Oncology，Henan University Affiliated Yihe Hospital

    Zhengzhou, Henan, 450047

    Yanwei Guo, MD, 15238608788, zzymyygyw@163.com

    Yanwei Guo, MD

    Recruiting

Other trials in China

About this study

Official title: Phase Ⅲ Study of Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer by Nadroparin

To compare the efficacy and safety of prophylaxis of venous thromboembolism by Nadroparin during hospitalization to long-term usage in patients with advanced lung cancer treated by chemotherapy and/or radiotherapy.

Read the detailed description

This is a prospective, multi-center, randomized and controlled study. Advanced lung cancer patients without venous thromboembolism(VTE) are included. The selected patients were randomized into A and B groups. Group A: Nadroparin given during hospitalization, 0.4mL, subcutaneously, qid; Group B: Nadroparin given by long-term, 0.4mL, subcutaneously, qid. The incidence of VTE , the risks of bleeding and overall survival in two groups of patients are studied at different time points.

Conditions
Lung Cancer
Being tested
Nadroparin, long term, Nadroparin: short-term
Keywords
Nadroparin, venous thromboembolism prophylaxis
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Nadroparin, long termDrug

  • Nadroparin: short-termDrug

Study groups in NCT01980849
Study groupRoleWhat they receive
Long term prophylaxisExperimentalNadroparin, 0.4mL, subcutaneously, qid, given by long-term
Receives: Drug: Nadroparin, long term
Short-term prophylaxisActive comparatorNadroparin, 0.4mL, subcutaneously, qid, given during hospitalization
Receives: Drug: Nadroparin: short-term

What is being measured

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

  1. Incidence of venous thromboembolism

    Measured: 12 weeks

Secondary outcomes (1)

  1. Incidence of bleeding

    Measured: During 6 months

Timeline

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

  1. First posted11 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionNov 2016 (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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
272 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01980849
Sponsor's protocol ID
LCAN-20131105
Acronym
LCAN
Status last verified
Nov 2013
First submitted
5 Nov 2013
Last updated
21 Nov 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nadroparin, long term and Nadroparin: short-term in people with Lung Cancer, run by Shengqing Li at 24 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 3 inclusion and 4 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 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Shengqing Li, MD, PhD (+86-29-84771132), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of venous thromboembolism (time frame: 12 weeks). 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 NCT01980849.

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 21 Nov 2013.

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