Neoadjuvant Celecoxib in Newly Diagnosed Patients With Endometrial Carcinoma (CELEBRIDO)
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|ClinicalTrials.gov Identifier: NCT03896113|
Recruitment Status : Not yet recruiting
First Posted : March 29, 2019
Last Update Posted : May 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endometrium Cancer||Drug: Celecoxib 200mg capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label, proof of concept phase II study. One arm, no placebo: All the patient will received the treatment and biopsies before and after the treatment will be compared regarding Indoleamine 2,3-dioxygenase 1 (IDO-1) expression and Immune T cells infiltration of the tumour|
|Masking:||None (Open Label)|
|Official Title:||Influence of the Celecoxib Administration Before Surgery for Endometrial Cancer on Indoleamine 2,3-dioxygenase 1 (IDO1) Tumor Expression and Immune Cells Tumor's Infiltration|
|Estimated Study Start Date :||June 30, 2019|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Patients with confirmed primary endometrioid adenocarcinoma eligible for first line curative surgery will receive celecoxib 400 mg twice a day, for 15 days before the curative surgery for their endometrial cancer. The patients will undergo an endometrial biopsy at the inclusion and during the surgery.
Drug: Celecoxib 200mg capsule
Patient confirmed with endometrial cancer will received twice daily 200 mg Celecoxib, 15 days before the surgery.
Other Name: Cyclooxygenase-2 (COX-2) inhibitor
- Reduction of tumoural cells expression IDO after celecoxib treatment. If more than 10% of all the tumoural cells have a staining for IDO, the tumour is considered as IDO (+), if less than 10%. [ Time Frame: after 15 days of celecoxib administration ]
Reduction of Tumoral IDO expression after Celecoxib treatment by immunohistochemistry, digital identification of the cells and phenotype and computer count of IDO positive cells inside de tumour (then total number compared before and after the treatment). If more than 10% of all the tumoural cells have a staining for IDO, the tumour is considered as IDO (+), if less than 10%, it is considered as (-).
Based on animal models, the treatment with celecoxib should decreases IDO expression in tumoural cells, allowing an immune cells tumoural's infiltration.
- Modification of tumoural T Cells infiltration after the treatment with celecoxib. The number of Cluster of Differenciation (CD) 4 and CD8 T cells will be counted before and after the treatment. [ Time Frame: after 15 days of celecoxib administration ]Observed the modification of the T cell tumoral's infiltration after the celecoxib treatment by immunohistochemistry, digital identification of the cells and phenotype and computer count of the different T cells population inside de tumour (then total number compared before and after the treatment). The number of CD4 and CD8 T cells will be counted before and after the treatment and the median of all the sample before and after the treatment will be compared to assess if there is a significant difference of total number of T cells before and after the treatment. Unit= nombre of CD4 and CD8 T Cells. Based on animal model, the investigators expect to have a significant increase of T cells infiltration after the celecoxib treatment
- Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Event Version 4.0 (CTCAE v4.0). [ Time Frame: from the first intake of the celecoxib to one day after the surgery ]
Assessment and scaling of adverse events according to CTCAE v4.0, Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated;
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to Adverse Event.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896113
|Contact: Mathieu Luyckx, MD||27649509 ext +email@example.com|
|Contact: Jean-Luc Squifflet, PhD||27641071 ext +firstname.lastname@example.org|
|Cliniques Universitaires Saint Luc|
|Brussels, Belgium, 1200|
|Gasthuisberg - KULeuven||Not yet recruiting|
|Leuven, Belgium, 3000|
|Contact: Ignace Vergote, PhD 16 3 44635 ext + 32 email@example.com|
|Contact: An Coosemans, PhD 16 3 44635 ext +32 firstname.lastname@example.org|
|Study Director:||Benoit van den Eynde, PhD||Institut de Duve - UCL|
|Study Director:||Nicolas Van Baeren, PhD||Institut de Duve- UCL|
|Study Chair:||Jean-François Baurain, PhD||Cliniques universitaire St-Luc|
|Study Chair:||Pierre van der Bruggen, PhD||Institut de Duve|