Endoscopic Assisted Electrochemotherapy in Addition to Neoadjuvant Treatment of Locally Advanced Rectal Cancer (nECT)
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|ClinicalTrials.gov Identifier: NCT03040180|
Recruitment Status : Unknown
Verified January 2019 by Zealand University Hospital.
Recruitment status was: Recruiting
First Posted : February 2, 2017
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Rectal Cancer Electrochemotherapy Neoadjuvant Therapy Down Staging||Drug: Electrochemotherapy with bleomycin Device: EndoVE||Phase 2|
Electroporation of cancer cells allows for a greater concentration of chemotherapy drugs to enter the tumor cells. The uptake of the chemotherapeutic drug is aided through the application of short electric pulses to the tumor mass (referred to as - Electrochemotherapy or ECT). The pulses make the tumor cells more porous which allows the drug easier access into the cancer cells, whereas other tissues and organs in the body remain relatively poor at absorbing the drug, thereby reducing the potential side effects on healthy tissues. Procedures with electrochemotherapy have previously been applied to human patients in other countries of the EU, the US and Japan.
The drug concentration used is significantly reduced due to the more targeted absorption by the tumor and this significantly reduces side effects normally associated with chemotherapy.
A large number of preclinical and clinical Phase I and I/II studies have demonstrated the efficiency and safety of ECT. These studies have included patients with melanoma, head and neck squamous cell carcinoma, merkel cell carcinomas, basal cell carcinoma and adenocarcinoma nodules.
An endoscopic system (EndoVE ) for delivering the electric pulses to gastrointestinal tumors has recently been developed. The treatment procedure is similar to standard endoscopic colorectal examination (therapeutic colonoscopy) with the added element of an intravenous injection of bleomycin followed by the delivery of electric pulses (each one less than 1msec in duration). The pulses are endoscopically delivered directly to the tumor mass. The entire procedure is minimally invasive and completely ambulatory. A successful treatment will cause the tumor to shrink in size in the weeks following the procedure.
The objective of this study is to investigate the efficacy and safety of this approach in downsizing locally advanced rectal tumors prior to intended curative surgery.
- All patients will be treated with standard neoadjuvant chemoradiation therapy prior to enrollment in this trial.
- Alle patients will have PET/MRI scans performed twice to evaluate treatment response (before and after ECT)
- ECT treatment will be performed 4 weeks prior to surgery outlined by MDT.
- Alle patients will be followed up for 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Endoscopic Assisted Electrochemotherapy in Addition to Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Randomized Clinical Phase II Trial|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Electrochemotherapy with bleomycin
Systemic injection of bleomycin followed by electroporation of the primary tumor. Bleomycin administration: 15.000 IU/m2 BSA.
BSA by Du Bois formula.
Drug: Electrochemotherapy with bleomycin
Systemic injection, once only treatment
Electroporation using an endoscopic electroporation device
Other Name: Endoscopic electroporation
No Intervention: Standard care
- Histopathologic tumor regression following electrochemotherapy [ Time Frame: 4 weeks ]Number of participants with histopathologic tumor regression following elctrochemotherapy as assesed by histopathological evaluation of Tumor Regression Grade (Mandard Classification, TRG 1-5)
- Treatment safety of electrochemotherapy [ Time Frame: 4 months ]Number of participants with treatment-related adverse events as assesed by CTCAE version 4.0
- Treatment safety of surgery following electrochemotherapy [ Time Frame: 4 weeks ]Number of participants with compromized surgery following electrochemotherapy assesed by R1 resection rate, CRM involvement, non-mesorectal resection plane, and post operative complications according to Clavien-Dindo Classification
- Tumor regression according to Hybrid PET/MRI following electrochemotherapy [ Time Frame: 4 weeks ]Tumor regression as assesed by tumor stage (T-stage)
- Tumor Immunologic response following electrochemotherapy [ Time Frame: 4 weeks ]Tumor immunologic infiltration as assesed by the Immunoscore through immunohistochemical analysis
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): NCT03040180
|Contact: Ismail Gögenur, MD, DMSc||+45 firstname.lastname@example.org|
|Contact: Rasmus P Vogelsang, MD||+45 email@example.com|
|Department of Oncology||Recruiting|
|Herlev, Capitol Region, Denmark, 2730|
|Contact: Julie Gehl, MD, DMSc +45 38683868 firstname.lastname@example.org|
|Department of Surgery||Recruiting|
|Roskilde, Denmark, 4000|
|Contact: Ismail Gögenur, MD, DMSc +45 26336426 email@example.com|
|Contact: Rasmus P Vogelsang, MD +45 27351103|
|Principal Investigator:||Ismail Gögenur, Professor||Department of Surgery, Zealand University Hospital|
|Principal Investigator:||Julie Gehl, MD, DMSc||Department of oncology, herlev Hospital|