Colorectal Cancer Clinical Trial
— MIRCASTOfficial title:
A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis
Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the
hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and
the associated regional fat and lymph nodes, and is the accepted treatment for malignant
neoplasms of the right colon.
A minimally invasive approach is commonly used for right colectomy, with studies reporting
reduced complications, less blood loss, and hospital stay when compared to an open approach.
However, there remains controversy regarding whether robotic assistance is advantageous for
this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is
best.
MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts
study. Sites or surgeons will select a cohort of the study for which they are qualified. Four
cohorts will be the subject of study:
1. Robotic Right Colectomy with ICA
2. Robotic Right Colectomy with ECA
3. Laparoscopic Right Colectomy with ICA
4. Laparoscopic Right Colectomy with ECA
All patient assessments will be done according to the sites standard of care. Parameters
routinely recorded during right colectomy surgery will be collected prospectively. Enrolled
subjects will undergo assessments at the following intervals: pre-operative, operative,
discharge, 30 days, 3 months, 1 year and 2 years post-surgery.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | December 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years or older. - Right colon tumor with indication for right colectomy (benign or malignant disease) - Patient has a life expectancy of at least 12 weeks - Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of =2) - Patient has signed and dated the Informed consent before patient inclusion in the study Exclusion Criteria: - Patient with a comorbid illness or condition that would preclude the use of surgery - Patients with cT4b tumors - Patients unwilling to comply with all follow-up study requirements - Patient undergoing emergency procedures - Planned colonic surgery along with major concomitant procedures (e.g. liver resections, other intestinal resections) - Metastatic disease - Pregnant or suspected pregnancy - Inflammatory Bowel Disease (Crohn´s Disease or Ulcerative Colitis) |
Country | Name | City | State |
---|---|---|---|
Croatia | County Hospital Požega | Požega | |
Denmark | Hospital of Southern Denmark | Aabenraa | |
Denmark | Zealand University Hospital | Køge | |
Finland | Kanta-Hämeen Keskussairaala | Hämeenlinna | |
Finland | Kymenlaakso Central Hospital | Kotka | |
Finland | Päijät-Häme Central Hospital | Lahti | |
Finland | Oulu University Hospital | Oulu | |
Finland | Seinäjoki Central Hospital | Seinäjoki | |
France | Hôpital Haut-Lévèque- CHU | Bordeaux | |
France | CHU Estaing | Clermont-Ferrand | |
France | ICM - Institut Régional du Cancer de Montpellier | Montpellier | |
France | CHRU de Strasbourg Hôpital Civil | Strasbourg | |
France | CHRU Nancy Brabois | Vandœuvre-lès-Nancy | |
Germany | Medizinische Hochschule Hannover | Hannover | |
Greece | Eurokliniki Athinou | Athens | Athina |
Italy | AOU-Careggi | Florence | |
Italy | Ospedale La Misericordia | Grosseto | |
Italy | IEO - European Institute of Oncology | Milan | |
Italy | Policlínico Agostino Gemelli | Roma | |
Italy | Humanitas Research Hospital | Rozzano | |
Italy | IRCCS Istituto di Candiolo | Torino | |
Portugal | Centro Hospitalar de Leiria | Leiria | |
Spain | Complejo hospitalario de Torrecardenas | Almería | |
Spain | Hospital Universitario Vall d´hebron | Barcelona | Cataluña |
Spain | Hospital General Universitario de Elche | Elche | Alicante |
Spain | Hospital de León | León | |
Spain | Hospital Clínico San Carlos | Madrid | |
Spain | Hospital Universitario 12 de octubre | Madrid | |
Spain | Hospital Central de Asturias | Oviedo | Asturias |
Spain | Hospital Universitario Donostia | San Sebastián | Pais Vasco |
Spain | Hospital Universitario Marqués de Valdecilla | Santander | Cantabria |
United Kingdom | Portsmouth Hospital NHS Trust | Portsmouth |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Marqués de Valdecilla |
Croatia, Denmark, Finland, France, Germany, Greece, Italy, Portugal, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Procalcitonine (PCT) days 1, 3 & 5 postoperative | PCT values on postoperative dates 1, 3 and 5 | 1, 3 and 5 postoperative days | |
Other | Time to deambulation | Time until patient gets out of bed and engages in light activity (such as sitting, standing, or walking) | 30 days | |
Other | Return to work/activity | o Time to start working/activity at patient´s job again | 30 days and 3 months | |
Other | Pain evaluation | Visual analogue scale (VAS) scores at postoperative days. Scores will range from 0 to 10 (0 no pain and 10 a pain you would rather prefer to die). | Postoperative days 1, 3 and 5 | |
Primary | Surgical wound infection | (CDC definition [Health Protection Agency. Surveillance of Surgical Site Infection in England: October 1997-September 2005. London: Health Protection Agency; 2006): Superficial incisional, affecting the skin and subcutaneous tissue. These infections may be indicated by localised (Celsian) signs such as redness, pain, heat or swelling at the site of the incision or by the drainage of pus. | 30 days | |
Primary | Clavien Dindo Complication | Complications according to Clavien Dindo Classification. | 30 days | |
Secondary | Overall Survival | The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive | 2 years | |
Secondary | Disease Free Survival (DFS) | Length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer. | 2 years | |
Secondary | Local Recurrence rate | Rate of cancer that has recurred at or near the same place as the original (primary) tumor | 2 years | |
Secondary | Distant metastases rate | Rate of Cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes | 2 years | |
Secondary | Rate of Unplanned Conversions to open surgery | When anything apart of the anastomosis had to be done through the laparotomy. If the anastomosis is not completely performed in an intracorporeal approach, the case is considered also converted | 7 days | |
Secondary | Operative time (min) | Operative time from skin to skin in minutes | 7 days | |
Secondary | Complete mesocolic excision (CME) | Complete Mesocolic Excision is defined as complete resection of the mesocolon with its anatomical envelope. Anatomical report should include any defect on CME specimen (Hohenberger W, Weber K., Matzel K., Papadopoulost T., Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation - technical notes and outcome. Colorectal Disease 11, 354-365 2008. doi:10.1111/j.1463-1318.2008.01735.x) | 30 days | |
Secondary | Number of Harvested Lymph Nodes | Number of harvested Lymph nodes according to the definitive pathological report. | 30 days | |
Secondary | R0 Resection | Rate of resection without any affected margins during the surgical procedure. | 30 days | |
Secondary | Length of Stay (LOS, days) | In hospital stay of the patient from the day that they are admitted before surgery to the day that they are fit to leave the hospital after the procedure. | 3 months | |
Secondary | Ventral hernia (assessed 1& 2 years after the right colectomy) | Incidence of ventral hernia 1 year after the procedure and 2 years after the procedure at the laparotomy site. | 1 and 2 years after the procedure | |
Secondary | Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 | Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score 3 months and 1 year after the procedure. | 3 months and 1 year after the procedure | |
Secondary | Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 | Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 Score 3 months and 1 year after the procedure. | 3 months and 1 year after the procedure | |
Secondary | C-Reactive Protein value (CRP) days 1 & 3 postoperative | CRP values on postoperative day 1 and 3. | 1 and 3 postoperative days. |
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 |