The objective of the MORE studies is to select and validate a biomarker profile predictive for the response to weekly paclitaxel and carboplatin chemotherapy concomitant with radiotherapy in patients with esophageal cancer.In the MORE-1 pilot study…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are differences in kinetic profile and/or genetic
profile between patients with and without a pathologic complete response after
chemo radiation.
Primary endpoint for evaluation in the MORE-1 study is pathologic complete
response in the resected material.
Primary endpoint for evaluation in the MORE-2 study is survival
Secondary outcome
Secundary endpoints for evaluation in the MORE-1 study are pathological
response, locoregional disease free survival, distant metastasis free survival,
disease free survival and survival.
Secundary endpoints for evaluation in the MORE-2 study are locoregional disease
free survival, distant metastasis free survival and disease free survival.
Background summary
In the Netherlands chemo radiation followed by surgery is the standard
treatment regimen for patients with resectable esophageal cancer. The addition
of chemo radiation does improve the median 5 year survival with absolute 13% to
47%. Thirty percent of patients has a pathological complete response after
chemo radiation. This observation implies that avoiding surgery can become an
option in those patients whose tumor responds very well to chemo radiation.
There is a need for adequate prognostic and predictive information available
before start of treatment in order to tailor treatment modalities (personalized
medicine).
Besides from morphological type (squamous cell carcinomas have a better
response than adeno carcinomas), there are no validated clinical markers,
pathological markers or biomarkers available that adequately predict the
response to chemo radiation. A multimodal approach, combining genomics and
proteomics will probably improve the possibilities to define and validate a set
of predictive biomarkers successfully.
Study objective
The objective of the MORE studies is to select and validate a biomarker profile
predictive for the response to weekly paclitaxel and carboplatin chemotherapy
concomitant with radiotherapy in patients with esophageal cancer.
In the MORE-1 pilot study candidate biomarkers are selected using a multimodal
approach combining genomics (next generation sequencing) and
proteonomics/kinomics (kinase activity profiling). The first cohort of 30
patients is used for the selection of biomarkers, the second cohort of 30
patients for validation.
The objective of the MORE-2 study is to validate the classifier that is
developed in the MORE-1 study in patients treated with definitive chemo
radiation (without surgery).
Study design
A prospective, single-center pilot study, performed in Leeuwarden Medical
Center (MCL).
Study burden and risks
Extra biopsies will be taken from de esophageal tumor by endoscopy. The
endoscopic procedure is combined with the regular endoscopic ultrasonography
procedure. Diagnostic upper gastrointestinal endoscopy is a safe procedure. The
estimated overall complication rate (including biopsies) is 0,13% with an
associated mortality of 0,004%. One extra blood sample will be taken from the
patient combined with a routine blood collection.
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Listed location countries
Age
Inclusion criteria
Esophageal cancer with an indication for chemotherapie, radiotherapie with orwithout surgery with curative intention
Exclusion criteria
Metastatic disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | 22490 |
| CCMO | NL53633.099.15 |
| OMON | NL-OMON23044 |