To investigate if there is a correlation between tumor perfusion and oxygenation, and downgrading of the tumor. This in order to better select those patient upfront, who will truely benifit from adjuvant radiation therapy.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Correlation between perfusion and oxygenation in tumor and rectal mucosa and
downgrading of the tumor.
Secondary outcome
-Radiation therapy induced changes in the perfusion and oxygenation of the
rectal mucosa.
-Correlation between rectal mucosal perfusion and oxygenation and anastomotic
leakage.
Background summary
Neoadjuvant radiation therapy has become standard in patients with mid and low
rectal cancer in order to improve local control and reduce tumor load.
Study objective
To investigate if there is a correlation between tumor perfusion and
oxygenation, and downgrading of the tumor. This in order to better select those
patient upfront, who will truely benifit from adjuvant radiation therapy.
Study design
Perfusion and oxygenation in the rectal mucosa and central tumor will be
measured with the laser-Doppler-spectrophotometry O2C-device before radiation
therapy and just before surgical resection of the tumor (6-8 weeks following
radiation theraly). Downgrading of the tumor will be evaluated according to
imaging with the MRI and histology reports from the pathology department.
Study burden and risks
At the same time as perfusion measurements blood will be drawn, which would not
have been done otherwise. The other perfusion measurements will be carried out
during other regular diagnostisch procedures and therfore do not form an
additional burden for the patient.
De Boelelaan 1117
Postbus 7700, 1000 SN Amsterdam
Nederland
De Boelelaan 1117
Postbus 7700, 1000 SN Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1. Patients undergoing neoadjuvant radiation therapy at the VU University medical center for rectal cancer.
2. age 18 years and older
3. informed consent
Exclusion criteria
1. no informed consent
2. palliative treatment
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 | NL22168.029.08 |