Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery

This research is investigating a special blood test called ‘circulating tumour DNA’ (ctDNA) for people who have had surgery for a specific type of colon cancer (Stage IIA). After surgery, even if scans look clear, tiny pieces of cancer DNA can sometimes still be in the blood. These are too small for regular tests to find. The study aims to find out if detecting these small cancer pieces with ctDNA testing can help doctors predict who might benefit from chemotherapy and who might not. This could help tailor treatments more precisely, avoiding chemotherapy for those who don't need it and ensuring it's given to those who do, potentially improving recovery and reducing the chance of cancer coming back.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

NRG Oncology

Enrolment target

635

Start

16 Dec 2019

Estimated completion

21 Jun 2026

Colon Adenocarcinoma Stage IIA Colon Cancer AJCC v8

Results

Results from this study

Posted April 2025

Results have been published for this study.

Primary outcome

Clearance of Circulating Tumor Deoxyribonucleic Acid (ctDNA) (to Undetectable Levels) for the "Baseline ctDNA Detected" Patient Subset (Phase II)

A two by two contingency table of clearance by treatment arm will be created. The one-sided Fisher exact p-value will be used to determine futility based on the rule specified. Degenerate tables where the Fisher p-value cannot be calculated (no patients clear on either arm or all patients clear on both arms) will count as a failure and a recommendation for early termination.

Full results on the registry

What is this study about?

This study is looking into a new way to help people with a specific type of colon cancer, called Stage IIA, after they've had surgery. When you have stage IIA colon cancer, it means the cancer has grown into the wall of the bowel but hasn't spread to nearby lymph nodes or other parts of the body. Even after surgery to remove the cancer, there's a chance a few tiny cancer cells might be left behind in the body. These are often too small to be seen on regular scans.

This is where a special blood test comes in, called circulating tumour DNA (ctDNA) testing. ctDNA is basically tiny fragments of cancer cells that have broken off and are floating in your bloodstream. If ctDNA is found in your blood after surgery, it suggests there might still be some cancer cells present, even if they're too small for other tests to detect. The main goal of this study is to see if finding ctDNA can help doctors decide whether someone would benefit from chemotherapy after surgery, or if they can simply be watched closely.

By understanding whether ctDNA predicts who needs chemotherapy, doctors hope to make better treatment choices. This could mean some people avoid chemotherapy and its side effects if they don't need it, while others receive it to reduce the chance of their cancer coming back. This study is split into two parts (Phase II and Phase III) to first check how well the ctDNA test works and then to see if using it actually leads to better outcomes for patients, like preventing the cancer from returning.

Key takeaways

This study uses a blood test (ctDNA) to guide treatment for colon cancer after surgery.
It aims to see if the ctDNA test can predict who needs chemotherapy and who doesn't.
Participation might mean avoiding chemotherapy or ensuring you receive it if beneficial.
The study focuses on Stage IIA colon cancer patients who have had surgery.
Chemotherapy drugs like Capecitabine and Oxaliplatin are being investigated.

Who may be eligible?

To be part of this study, you would generally need to be an adult (18 years or older) and have been diagnosed with Stage IIA colon cancer that has been completely removed by surgery. This means the cancer was T3, N0, M0, according to the doctors' classification, and at least 12 lymph nodes were checked during your operation.

Your general health needs to be good enough for you to take part, as assessed by your doctor. This includes having certain blood test results within a healthy range, like your blood cell counts and liver function. Also, your cancer shouldn't have been too close to your bottom (at least 12cm away from the anus) to make sure it's definitely colon cancer being studied, not rectal cancer that is treated differently.

Finally, your surgeon must have been able to remove all of the visible cancer in one go, and the surgery must have taken place between 14 and 60 days before you would be officially enrolled in the study. Your medical team will carefully review all your records to ensure you meet all the specific requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Stage IIA colon cancer?
Has your colon cancer been completely removed by surgery?
Is your general health good enough for participation, as assessed by your doctor?
Was your tumour at least 12cm away from your anal opening?

Answer every question to see your result.

What does participation involve?

If you join this study, the exact details of your involvement will depend on whether ctDNA is found in your blood. You will need to provide samples of your tumour tissue from your surgery for special tests. After your surgery, blood tests will be taken to check for ctDNA. If ctDNA is detected, you would be randomly assigned to either receive chemotherapy (using medicines like Capecitabine, Fluorouracil, Leucovorin, Leucovorin Calcium, or Oxaliplatin) or to be carefully observed without chemotherapy. If no ctDNA is detected, you would be monitored. Your health will be closely followed by your medical team through regular check-ups, blood tests, and scans over a period of time to see if the cancer returns. The total length of your participation would be determined by the study protocol, including follow-up appointments.

Potential risks and benefits

Participating in this study might offer the benefit of a more personalised treatment plan, potentially avoiding chemotherapy and its side effects if it's not needed, or ensuring you receive it if it's likely to help prevent your cancer from returning. However, there are potential risks, especially if you are assigned to receive chemotherapy, which can have various side effects. If you are in the observation group, there's a theoretical risk that you might miss out on chemotherapy that could have been beneficial. Your medical team will discuss all potential risks and benefits in detail. Remember, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (957)

University of Alabama at Birmingham Cancer Center
Verified postcode
Birmingham, United States
University of South Alabama Mitchell Cancer Institute
Verified postcode
Mobile, United States
Anchorage Associates in Radiation Medicine
Verified postcode
Anchorage, United States
Anchorage Radiation Therapy Center
Verified postcode
Anchorage, United States
Alaska Breast Care and Surgery LLC
Verified postcode
Anchorage, United States
Alaska Oncology and Hematology LLC
Verified postcode
Anchorage, United States
Alaska Women's Cancer Care
Verified postcode
Anchorage, United States
Anchorage Oncology Centre
Verified postcode
Anchorage, United States
Katmai Oncology Group
Verified postcode
Anchorage, United States
Providence Alaska Medical Center
Verified postcode
Anchorage, United States
Fairbanks Memorial Hospital
Verified postcode
Fairbanks, United States
Kingman Regional Medical Center
Verified postcode
Kingman, United States

Common questions

What is ctDNA?

ctDNA stands for 'circulating tumour DNA'. It's tiny pieces of genetic material from cancer cells that may be found in your blood, even if the main tumour has been removed.

Why is this study important?

This study aims to help doctors decide more accurately if chemotherapy is needed after surgery for Stage IIA colon cancer, potentially helping some patients avoid unnecessary treatment.

Will I definitely receive chemotherapy if I join?

Not necessarily. If ctDNA is found in your blood, you will be randomly assigned to either receive chemotherapy or be closely observed. If no ctDNA is found, you will be observed.

What kind of chemotherapy might be used?

The chemotherapy drugs being studied include Capecitabine, Fluorouracil, Leucovorin, Leucovorin Calcium, and Oxaliplatin.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point without it affecting your usual medical care.