Colon Cancer Clinical Trial
Official title:
PRODIGE 22-ECKINOXE : Randomized Phase II Trial of Neoadjuvant FOLFOX 4 Versus FOLFOX 4 With Cetuximab Versus Immediate Surgery in Locally Advanced Colon Cancer
In patients with locally advanced colon cancer (high risk stage II and stage III), curative
surgery followed by adjuvant FOLFOX-4 chemotherapy has become the standard of care. However,
for 30-40% of these patients, the current curative treatment strategy of surgical excision
followed by adjuvant chemotherapy fails either to clear locoregional spread or to eradicate
distant micrometastases, leading to disease recurrence. Preoperative chemotherapy is an
attractive concept for locally advanced colon cancer and has the potential to impact upon
both of these causes of failure. Optimum systemic therapy at the earliest possible
opportunity may be more effective at eradicating distant metastases than the same treatment
given after the delay and immunological stress of surgery. Added to this, shrinking the
primary tumor before surgery may reduce the risk of incomplete surgical excision, and the
risk of tumor cell shedding during surgery.
ECKINOXE is a multicenter randomized phase II trial designed to evaluate efficacy (response
rate) and feasibility (safety, tolerance) of these two chemotherapy regimens (FOLFOX-4 alone
and FOLFOX-4+Cetuximab) in a neoadjuvant strategy in patients with locally advanced colon
cancer. Control arm includes patients for whom standard treatment comprises surgery followed
by adjuvant FOLFOX-4 chemotherapy. This phase II study will assess the feasibility of a
neoadjuvant strategy in these patients and determine which neoadjuvant regimen is the most
effective in terms of response rate.
See Synopsis below ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
| Completed |
NCT03457454 -
Reducing Rural Colon Cancer Disparities
|
||
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04088955 -
A Digimed Oncology PharmacoTherapy Registry
|
||
| Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
| Terminated |
NCT01347645 -
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT03390907 -
Hybrid APC Assisted EMR for Large Colon Polyps
|
N/A | |
| Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
| Completed |
NCT04079478 -
The AID Study: Artificial Intelligence for Colorectal Adenoma Detection
|
||
| Active, not recruiting |
NCT04057274 -
Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth
|
N/A | |
| Recruiting |
NCT03190941 -
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05147545 -
Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects
|
N/A | |
| Recruiting |
NCT05026268 -
The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis
|
N/A | |
| Not yet recruiting |
NCT03277235 -
Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients
|
N/A | |
| Active, not recruiting |
NCT02959541 -
PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer
|
N/A | |
| Active, not recruiting |
NCT02730702 -
Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
|
||
| Completed |
NCT02810652 -
Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
|
N/A | |
| Recruiting |
NCT02577627 -
Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC
|
N/A | |
| Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 | |
| Recruiting |
NCT02526836 -
Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer
|
Phase 2/Phase 3 |