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Efficiency Study for Acute Radiation-induced and Chemotherapy-induced Pulmonary Fibrosis With Bevasizumab

Q

Qingdao Central Hospital

Status and phase

Enrolling
Phase 2

Conditions

Pulmonary Fibrosis

Treatments

Drug: Dexamethasone
Drug: Bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT01917877
QCH-20030801

Details and patient eligibility

About

Due to the radiosensitivity of the lung, radiation-induced and chemotherapy-induced pneumonitis and pulmonary fibrosis are frequent happened following cancer therapy. It not only compromise cancer treatment, but also influence patient's life qualities and even death. there are no specific treatment modalities for this treatment-induced complication. Bevasizumab (Avastin), a VEGF inhibitor, can attenuate serum high expression VEGF and pulmonary permeability, maybe effective in the control acute pulmonary fibrosis. Patients will be randomized to receive Bevasizumab (7mg/kg iv) on day one and 21, followed by Dexamethasone (10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20) or Dexamethasone alone. The thoracic CT, plasma TNF-a, IL-6, VEGF and C-reactive protein are accessed on before treatment, 24 hours after Bevasizumab, 7 days, 4 and 8 weeks. the target sample size is 30 cases.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • clinical diagnosed cancer treatment-induced acute pulmonary fibrosis

Exclusion criteria

  • chronic pulmonary fibrosis and infection-induced pulmonary fibrosis
  • active bleeding
  • uncontrolled high blood pressure
  • unstable systemic disease
  • prior exposure to VEGF inhibitor

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

study group
Experimental group
Description:
Bevacizumab 7mg/kg iv on day1 and 21, followed by Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
Treatment:
Drug: Bevacizumab
control
Active Comparator group
Description:
Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
Treatment:
Drug: Dexamethasone

Trial contacts and locations

1

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Central trial contact

youxin ji, md

Data sourced from clinicaltrials.gov

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