dMR During First Line Treatment of Non Squamous Lung Cancer: Time Course and Prognostic and Predictive Impact.

Sponsor
Karl Kölbeck
Study ID
NCT02195336
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • dMRT — DEVICE
    Baseline, day 8, day 28, day 92, progression/relapse.
  • Bevacizumab — DRUG
    7.5mg/kg every 3 weeks for 3 cycles. Thereafter every 3 weeks until progression/relapse or unacceptable toxicity.
  • paclitaxel and carboplatin — DRUG
    Standard of care NSCLC first-line chemotherapy Every 3 weeks for 3 cycles. Doublets containing paclitaxel and carboplatin are preferred

Study Details

To date, there are no methods to reliably select which patients with non-squamous non-small cell lung cancer (NSCLC) that benefit most from treatment with bevacizumab. Data have shown that high levels of plasma VEGF are prognostic and correlates with a worse disease outcome in some tumour types, including advanced NSCLC. Recent data are suggestive of a predictive value of imaging techniques for early detection of antiangiogenic treatment efficacy in different cancers. To our knowledge there are no presented data available on correlation between changes in diffusion-weighted MR and response to bevacizumab treatment in lung cancer. The current study is designed as a pilot study to prospectively investigate changes in MR variables during treatment with bevacizumab and to detect signals of prognostic and/or predictive value of MR changes during treatment.

Key Dates

First listed
Jul 21, 2014
Start date
Aug 31, 2014
Status verified
Jul 2014
Primary completion
Jun 30, 2016
Completion
Jun 30, 2018

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: dMRT, Bevacizumab, Chemotherapy
    dMRT: Magnetic Resonance Tomograph, Baseline, day 8, day 28, day 92, progression/relapse. Bevacizumab: 7.5mg/kg every 3 weeks for 3 cycles. Standard of care NSCLC first-line chemotherapy, doublets containing paclitaxel and carboplatin are preferred, every 3 weeks for 3 cycles. Thereafter Bevacizumab 7.5mg/kg every 3 weeks until progression/relapse or unacceptable toxicity.

Primary Outcome Measure

dMRT changes during treatment [ Time Frame: Baseline, Day 8, Day 28, Day 92, At relapse. ]

Central Contacts

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