2.1 Primary objectives Primary objective is scientific research to study the additional effect of bevacizumab on hypoxia related parameters. 2.2 Secondary objectives a) To compare the efficacy of bevacizumab with pre-treatment obtained values of…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
oxygen saturation and vesseldiameter in the tumour before and after
chemotherapy with or without bevacizumab
Secondary outcome
survival of the patients
Background summary
Lungcancer is the second most common cancer in men and women, and is the
leading cause of cancer related death. In industrialized countries it kills
more patients than breast, colorectal and prostate cancer combined. Eighty-five
percent of patients with lungcancer have non-small-cel-lungcancer (NSCLC), and
60% of these patients present with an incurable stage IIIB or IV disease.
Prognosis of advanced lungcancer (both small cell and non-small cell) is bad.
Unfortunately, only palliative rather than curative treatment options are
present for these advanced cancers. Platinum-based chemotherapy is currently
the standard treatment in these patients and median survival time is typically
6-9 month after this standard therapy. [1]
Study objective
2.1 Primary objectives
Primary objective is scientific research to study the additional effect of
bevacizumab on hypoxia related parameters.
2.2 Secondary objectives
a) To compare the efficacy of bevacizumab with pre-treatment obtained values of
blood hypoxia related parameters.
b) To study the effect of standard treatment of chemotherapy without
bevacizumab on hypoxia related parameters.
Study design
suspicion of lung carcinoma
*
bronchoscopy with DPS after informed consent METC
*
NSCLC stage IV disease or extended SCLC
*
informed consent present trial randomisation
* *
standard treatment with bevacizumab standard treatment without
bevacizumab
* *
repeated bronchoscopy with DPS
*
treatment according to institutional policy
Study burden and risks
Standard risk by bronchscopy: damaging of the vocalcord, haemoptoe,
pneumothorax, hypoxemia, arrhythmias.
Molengracht 21
4818 CK Breda
Nederland
Molengracht 21
4818 CK Breda
Nederland
Listed location countries
Age
Inclusion criteria
· suspected endoscopically visible tumour
· written informed consent
· histologycally or cytologicoly documented inoperable advanged stage IV NSCLC or extensive SCLC
· WHO 1-2
· Life expectancy > 12weeks
· Adequate hemologycal/liver/renal function
· INR< 1,5
· In case of female, not pregnant or breastfeeding
Exclusion criteria
none
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL13188.078.06 |