Colorectal Cancer Clinical Trial
Official title:
Neoadjuvant Electrochemotherapy for Colorectal Cancer - a Randomized Controlled Trial
This is a randomized controlled trial investigating efficacy of electrochemotherapy for early colorectal cancer
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | December 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients must be mentally capable of understanding the information given. - Patients must give written informed consent. - Endoscopically suspected or histologically verified malignant tumor of the rectum or sigmoid colon. - Tumor described as passable at index endoscopy. - Men or women aged at least 18 years. - Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection. - ASA class I-II (Classification of the American Society of Anesthesiology) Exclusion Criteria: - Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery - Uncorrectable coagulation disorder. - Patients with ICD or pacemaker units. - Ongoing immunosuppressive treatment. - Patients with concomitant use of phenytoin. - Myocardial insufficiency, defined as NYHA class >2 - Concurrent treatment with an investigational medicinal product. - Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments. - Advanced tumor stages, clinical UICC stage IV. - Acute surgical resection. - Pregnancy - Medical history of severe pulmonary disease. - Previous cumulative dose of bleomycin exceeding 250mg/m2. - BMI > 35 - Renal impairment, defined as eGFR <40 ml/min |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Zealand University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor stage | Preoperative tumor stage will be compared with pathological assessment of the surgical specimen and comared between the two study arms using TNM stage | 6 months | |
Secondary | Gene expressional changes in the tumor microenvironment | Biopises are collected before the intervention and compared with the surgical specimen using NanoString technology. The PanCancer IO 360 gene panel will be used, a predefined panel of 770 genes. | 6 months | |
Secondary | Composition of fusobacterium | To characterize the spatial distribution and organization of bacteria in situ, some of the samples will be assessed microscopically. Confocal laser scanning microscopy will be performed on formalin-fixed, paraffin-embedded tissue of both diseased and normal tissue. This will allow us to investigate treatment affects the bacterial composition of fusobacterium. | 6 months | |
Secondary | PD-1/PD-L1 | Immunohistochemical staining for PD-1/PD-L1 | 6 months | |
Secondary | CD3 | Immunohistochemical staining for CD3 | 6 months | |
Secondary | CD8 | Immunohistochemical staining for CD8 | 6 months | |
Secondary | CD28 | Immunohistochemical staining for CD28 | 6 months | |
Secondary | VAR2 | Immunohistochemical staining for VAR2 | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |