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Chemotherapy
ctDNA Testing for Colon Cancer Treatment Prediction
Phase 2 & 3
Waitlist Available
Led By Van K Morris
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically/pathologically confirmed stage IIA adenocarcinoma of the colon (T3, N0, M0) with at least 12 lymph nodes examined at the time of surgical resection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial tests how well ctDNA testing in the blood predicts treatment for patients with stage IIA colon cancer after surgery. ctDNA are circulating tumor cells that are shed by tumors into the blood. Finding ctDNA in the blood means that there is very likely some small amounts of cancer that remain after surgery. However, this cancer, if detected, cannot be found on other tests usually used to find cancer, as it is too small. Testing for ctDNA levels may help identify patients with colon cancer after surgery who do benefit, and those who do not benefit, from receiving chemotherapy.
Who is the study for?
This trial is for patients with stage IIA colon cancer who've had surgery. They must have good blood counts, organ function, and a performance status of 0 or 1 (able to carry out daily activities). No other cancers in the last 5 years except certain non-aggressive types are allowed. Patients can't join if they've had recent chemotherapy or have serious heart issues, infections, neuropathy, DPD deficiency, pregnancy/lactation, or conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing whether checking ctDNA levels in the blood after surgery can predict which stage IIA colon cancer patients might benefit from chemotherapy. It's comparing outcomes between those who receive chemo drugs like Leucovorin Calcium, Oxaliplatin, Capecitabine and Fluorouracil versus those under observation without these treatments.See study design
What are the potential side effects?
Chemotherapy drugs used may cause side effects such as fatigue; nausea; mouth sores; low blood cell counts leading to increased infection risk; nerve damage causing numbness or tingling; diarrhea; and liver enzyme changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My colon cancer is stage IIA and was confirmed with a biopsy.
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My tumor is located more than 12 cm from the anal opening, confirmed by tests or surgery.
Select...
My kidney function, measured by creatinine or its clearance, is within the required range.
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I can provide tissue samples from my surgery for further testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clearance of circulating tumor deoxyribonucleic acid (ctDNA) (to undetectable levels) for the "baseline ctDNA detected" patient subset (Phase II)
Recurrence-free survival (RFS) the "baseline ctDNA detected" patient subset (Phase III)
Secondary outcome measures
Compliance with adjuvant chemotherapy and/or active surveillance
Incidence (presence or absence) of ctDNA in blood following resection of stage II colon cancer
Overall survival (OS)
+2 moreOther outcome measures
Cost effectiveness of the use of ctDNA versus standard of care
Genomic profiles
Quantitative ctDNA levels
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (blood tested for ctDNA at baseline)Experimental Treatment6 Interventions
Patients are assigned to 1 of 2 groups.
GROUP I (ctDNA DETECTED): At the discretion of the investigator, patients receive either oxaliplatin IV over 2 hours on day 1, leucovorin IV over 2 hours on day 1, and fluorouracil IV bolus over 2-4 minutes on day 1 and then by continuous IV over 46-48 hours repeated every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity or oxaliplatin IV over 2 hours on day 1 and capecitabine PO BID on days 1-14 repeated every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity at the discretion of the investigator.
GROUP II (ctDNA NOT DETECTED): Patients undergo active surveillance.
Group II: Arm I (blood stored and tested for ctDNA later)Active Control1 Intervention
Patients undergo active surveillance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
2005
Completed Phase 4
~5730
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin Calcium
2011
Completed Phase 3
~12290
Capecitabine
2013
Completed Phase 3
~3420
Fluorouracil
2014
Completed Phase 3
~11540
Find a Location
Who is running the clinical trial?
NRG OncologyLead Sponsor
231 Previous Clinical Trials
99,444 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,931,745 Total Patients Enrolled
Van K MorrisPrincipal InvestigatorNRG Oncology
3 Previous Clinical Trials
196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your ANC must be at least 1,200 cells per cubic millimetre of blood within four weeks prior to randomization.My oncologist agrees I can be monitored without immediate chemotherapy.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had cancer treatment, except hormone therapy, in the last 5 years.My colon cancer is stage IIA and was confirmed with a biopsy.You must have a hemoglobin value of at least 9 grams per decilitre within the four weeks preceding enrollment.My heart condition allows me to take the GI005 treatment drugs.I do not have severe numbness, tingling, or muscle weakness.I agree to weekly blood tests if I take capecitabine and use blood thinners.Platelet count must be at least 100,000/mm^3 within the preceding four weeks.My cancer has spread to other parts of my body.My bilirubin levels are normal or slightly elevated due to a chronic condition.I haven't had cancer, except for specific non-dangerous types, in the last 5 years.The patient must have provided a signed, dated consent form that meets all federal and institutional regulations as determined by the Institutional Review Board.I had surgery to remove my cancer completely between 14 to 60 days ago.I do not have any unstable heart conditions.My tumor is located more than 12 cm from the anal opening, confirmed by tests or surgery.I am being treated for a specific type of irregular heartbeat with certain heart medications.My colon cancer is not adenocarcinoma but another type like neuroendocrine or lymphoma.My kidney function, measured by creatinine or its clearance, is within the required range.I have not had chemotherapy, targeted therapy, immunotherapy, or radiation for colorectal cancer.I am currently on medication for a long-term infection.I have a known DPD deficiency.My cancer has caused a hole in my intestine.I have had colon cancer before.I have a serious heart rhythm problem treated with a pacemaker.I have had an organ transplant.I have cancer in both my rectum and colon at the same time.My seizures are not controlled by medication.I can provide tissue samples from my surgery for further testing.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (blood tested for ctDNA at baseline)
- Group 2: Arm I (blood stored and tested for ctDNA later)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Colon Cancer Patient Testimony for trial: Trial Name: NCT04068103 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial being conducted in many hospitals throughout Canada?
"There are 100 sites running this study, including the Queen's Cancer Center in Honolulu, Saint Luke's Cancer Institute in Boise, and Flaget Memorial Hospital in Bardstown."
Answered by AI
Are there any other ongoing studies that are using Capecitabine?
"There are 789 ongoing clinical trials studying capecitabine. Of these, 262 are Phase 3 studies. The majority of research is based in Guangzhou, Guangdong; however, there are 31126 locations running trials for this treatment worldwide."
Answered by AI
How is Capecitabine most often employed in treatments?
"Capecitabine is most often used as a last-line treatment for refractory fallopian tube carcinoma, but it has also shown efficacy in the management of conditions such as joints, rectal carcinoma, and osteoporosis."
Answered by AI
Who else is applying?
What state do they live in?
California
Michigan
Ontario
Other
What site did they apply to?
Mission Hope Medical Oncology - Arroyo Grande
Elmhurst Memorial Hospital
McLaren Cancer Institute-Central Michigan
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1
What questions have other patients asked about this trial?
If I have already done ctDNA testing through NEO Genomics, am I eligible for the trial?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
Was diagnosed by it knows five years ago with colorado cancer at surgery most of a removing surgery was just wondering what was available.
PatientReceived 1 prior treatment
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