Lynch Syndrome Clinical Trial
Official title:
A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin Versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers
This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer.
PRIMARY OBJECTIVES: I. To demonstrate an improvement in 3-year disease-free survival for high-risk stage II colon cancer patients randomly assigned to 5-FU (fluorouracil), leucovorin (leucovorin calcium), oxaliplatin versus 5-FU, leucovorin, oxaliplatin and bevacizumab. SECONDARY OBJECTIVES: I. To compare overall survival between the regimens. II. To further define the toxicity profiles of the regimens. III. To prospectively determine the impact of tumor biological characteristics on the survival of patients with stage II colon cancer. IV. To assess the association between oxaliplatin exposure, allelic variants in candidate genes, and neurotoxicity. (Pharmacogenetic ancillary objective) OUTLINE: Patients with high-risk disease are randomized to 1 of 2 treatment arms (Arms A and B). Patients with low-risk disease are assigned to Arm C. ARM A: Patients receive oxaliplatin intravenously (IV) over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity. ARM C: Patients undergo observation. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 10 years. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00905710 -
Chromoendoscopy to Decrease the Risk of Colorectal Neoplasia in Lynch Syndrome
|
N/A | |
| Active, not recruiting |
NCT02194387 -
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
|
N/A | |
| Recruiting |
NCT04909671 -
Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome.
|
N/A | |
| Recruiting |
NCT04379999 -
Atorvastatin ± Aspirin in Lynch Syndrome Syndrome
|
Early Phase 1 | |
| Recruiting |
NCT05692596 -
The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
|
||
| Completed |
NCT01845753 -
Molecular Screening for Lynch Syndrome in Denmark
|
||
| Completed |
NCT01216930 -
Molecular Screening for Lynch Syndrome in Southern Denmark
|
N/A | |
| Not yet recruiting |
NCT05963191 -
CAD-EYE System for the Detection of Neoplastic Lesions in Patients With Lynch Syndrome
|
N/A | |
| Active, not recruiting |
NCT02912559 -
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
|
Phase 3 | |
| Recruiting |
NCT04978350 -
Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study
|
N/A | |
| Active, not recruiting |
NCT03832985 -
Pediatric Reporting of Adult-Onset Genomic Results
|
Early Phase 1 | |
| Withdrawn |
NCT04778566 -
Evaluating the Cologuard Test for Use in Lynch Syndrome
|
||
| Completed |
NCT02570516 -
NBI Versus Indigo Carmine During Colonoscopy in Lynch Syndrome
|
N/A | |
| Completed |
NCT01823471 -
I-Scan For Colon Polyp Detection In HNPCC
|
N/A | |
| Recruiting |
NCT02813824 -
Effect of Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome
|
Phase 3 | |
| Recruiting |
NCT05078866 -
Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03744962 -
MSI in Circulatory DNA of Endometrial Cancer
|
||
| Recruiting |
NCT04711434 -
PD-1 Antibody for The Prevention of Adenomatous Polyps and Second Primary Tumors in Lynch Syndrome Patients
|
Phase 3 | |
| Completed |
NCT04131062 -
Trial to Compare eConsent With Standard Consent Among Prospective Biobank Participants
|
N/A | |
| Recruiting |
NCT05704010 -
Videocapsule Endoscopy in Lynch Syndrome
|
N/A |