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Targeted Therapy for Colorectal Cancer
Study Summary
This trial is testing which of these treatments is better based on blood test results.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had more than 3-6 months of standard follow-up cancer treatment.I have another cancer that is getting worse or needs treatment.I am 18 years old or older.My cancer has been surgically removed.My cancer has a known mismatch repair deficiency.I cannot receive standard follow-up cancer treatment.My blood test shows cancer DNA after treatment, confirmed by a specific test.I have finished the standard additional cancer treatment.My colorectal cancer is Stage III and was confirmed through a biopsy.I haven't had cancer treatment like chemotherapy or immunotherapy in the last 30 days.I have a serious illness that is not under control.My organs and bone marrow are functioning normally.I do not have MSI-high or BRAF V600E mutation.I have not had chemotherapy before surgery.I am a woman who can have children and have a negative pregnancy test.I am currently being treated for an infection.I am willing to use two forms of birth control or abstain from sex.I do not have a BRAFV600E mutation and am not MSI-high.My cancer is located only in the colon, not the rectum.My cancer has spread to other parts of my body, confirmed by a CT scan.I am fully active and can carry on all my pre-disease activities without restriction.
- Group 1: 6 Months Additional Trastuzumab and Pertuzumab
- Group 2: ctDNA-POSITIVE: ACTIVE SURVEILLANCE
- Group 3: ctDNA-POSITIVE BRAF Mutant: ENCORAFENIB/BINIMETINIB/CETUXIMAB
- Group 4: ctDNA-POSITIVE: FOLFIRI Protocol
- Group 5: ctDNA-POSITIVE MSI-H: NIVOLUMAB
- Group 6: ctDNA-NEGATIVE: ACTIVE SURVEILLANCE
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you explain the standard reasoning for a FOLFIRI Protocol?
"The FOLFIRI Protocol can be used to treat small cell lung cancer (sclc), malignant neoplasms, and unresectable melanoma."
What do researchers hope to discover or prove with this experiment?
"The goal of this long-term clinical trial is to evaluate the clearance rate of ctDNA in patients. Secondary objectives of the study include determining the clearance rate of ctDNA in patients treated with encorafenib, binimetinib, and cetuximab, overall survival rate in patients treated with additional adjuvant therapy, and disease-free survival rate in patients treated with nivolumab."
Is the FOLFIRI Protocol a common research approach?
"As of now, there are 1393 clinical trials investigating the efficacy of the FOLFIRI Protocol. Of those active clinical trials, 247 are in Phase 3. The FOLFIRI Protocol is being trialed in Ciudad de Mexico and Maryland primarily, but there are 69407 locations running trials for this treatment globally."
Are people being signed up for this experiment right now?
"That is accurate, the clinicaltrials.gov website does show that this study is recruiting patients. This information was originally posted on 1/20/2020, with the most recent update on 2/11/2020. They are looking for 500 people to participate, at 2 different locations."
Has the FOLFIRI Protocol undergone FDA approval?
"FOLFIRI Protocol has been given a safety rating of 3 by our team at Power. This is due to the fact that it is a Phase 3 trial, signifying that there is both evidence of efficacy and multiple instances of data supporting safety."
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