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PhaseI/II Study of neoadjuvant therapy with Carboplatin Paclitaxel plus Bevacizumab for stage II/IIIA(>T2) Non-squamous Non-Small-Cell Lung Cancer

Phase 1
Conditions
non-squamous non-small-cell lung cancer
Registration Number
JPRN-UMIN000007129
Lead Sponsor
1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

Exclusion Criteria

1) Pleural effusion, pericardial effusion and ascites to need treatment 2) Current or previous histoty of hemoptysis (2.5ml) due to NSCLC 3) Evidence of bleeding diathesis or hemoptysis 4) With great vessel invasion 5) Cavity in tumor 6) Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day) 7) Active concomitant malignancy 8) Severe complications a)Current or previous history of cerebrovascular disease b)Current or previous history of GI perforation c)Severe cardiac disease d)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, pulmonary fibrosis or drug-induced pneumonitis e)Traumatic fracture of unrecovery f) Uncontrollable peptic ulcer g)Uncontrollable hypertenson h)Uncontrollable infectious disease 9) History of severe allergic reaction with platinum drug ,chemotherapy drug or monoclonal antibody 10) Pregnant or breast-feeding females 11) Decision of ineligibility by a physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
STEP1 Safety STEP2 Overall Response Rate
Secondary Outcome Measures
NameTimeMethod
Pathological Complete Response Rate Complete Resection Rate Relapse Free Survival Rate(1year,2years) Overall Survival Rate(1year,2years) Adverse events Blood loss during Oparation /Operation Time
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