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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.

Must not have

Antineoplastic therapy (e.g., chemotherapy, targeted therapy, or immunotherapy) within 5 years before randomization. (For the purposes of this study, hormonal therapy is not considered chemotherapy.).

Sensory or motor neuropathy >= grade 2, according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had cancer treatment, except hormone therapy, in the last 5 years.

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I do not have severe numbness, tingling, or muscle weakness.

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My cancer has spread to other parts of my body.

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I do not have any unstable heart conditions.

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My colon cancer is not adenocarcinoma but another type like neuroendocrine or lymphoma.

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I have not had chemotherapy, targeted therapy, immunotherapy, or radiation for colorectal cancer.

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I am currently on medication for a long-term infection.

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I have a known DPD deficiency.

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My cancer has caused a hole in my intestine.

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I have had colon cancer before.

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I have a serious heart rhythm problem treated with a pacemaker.

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I have had an organ transplant.

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I have cancer in both my rectum and colon at the same time.

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My seizures are not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Compliance with adjuvant chemotherapy and/or active surveillance

Overall survival (OS)

RFS

+1 more

Other study objectives

Genomic profiles

Quantitative ctDNA levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 Calcium

2011

Completed Phase 3

~12500

Oxaliplatin

2011