Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (LCAN)

Shengqing Li

Status and phase: Unknown; Phase 3

Conditions: Lung Cancer

Treatments: Drug: Nadroparin: short-term; Drug: Nadroparin, long term

Study type: Interventional

Funder types: Other

Identifiers

NCT01980849

LCAN-20131105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 272 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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272 participants in 2 patient groups

Long term prophylaxis

Experimental group

Description:

Nadroparin, 0.4mL, subcutaneously, qid, given by long-term

Treatment:

Drug: Nadroparin, long term

Short-term prophylaxis

Active Comparator group

Description:

Nadroparin, 0.4mL, subcutaneously, qid, given during hospitalization

Treatment:

Drug: Nadroparin: short-term