635 Participants Needed

ctDNA Testing for Colon Cancer Treatment Prediction

Recruiting at 1029 trial locations
VK
Chaoyuan Kuang profile photo
Overseen ByChaoyuan Kuang
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II/III trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) testing in the blood works in predicting 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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on a coumarin-derivative anticoagulant, you must agree to weekly monitoring of your INR if you are randomized to Arm 2 and receive capecitabine.

Is ctDNA testing for colon cancer treatment prediction safe for humans?

Capecitabine (Xeloda), an oral form of chemotherapy, has been shown to be generally safe in humans, with studies indicating it causes fewer side effects like diarrhea and nausea compared to traditional intravenous chemotherapy. However, it may cause hand-foot syndrome (redness and swelling of the hands and feet) and increased bilirubin levels (a substance in the blood that can indicate liver issues).12345

What makes the drug capecitabine unique for colon cancer treatment?

Capecitabine is unique because it is an oral drug that is designed to be activated directly at the tumor site, mimicking continuous infusion of 5-FU but with less toxicity and more convenience compared to traditional intravenous administration.12567

What data supports the effectiveness of the drug Capecitabine (Xeloda) for colon cancer treatment?

Research shows that Capecitabine (Xeloda) is as effective as the standard treatment of 5-FU and leucovorin for colorectal cancer, with similar survival rates and less toxicity. It is also effective when combined with oxaliplatin, providing a well-tolerated treatment option with good response rates.12458

Who Is on the Research Team?

VK

Van K Morris

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

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.

Inclusion 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.
See 14 more

Exclusion Criteria

Prior testing with any available ctDNA test as part of the management of colon cancer, is not permitted.
I haven't had cancer treatment, except hormone therapy, in the last 5 years.
My heart condition allows me to take the GI005 treatment drugs.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive chemotherapy or undergo active surveillance based on ctDNA detection

6 months
Every 14-21 days for chemotherapy cycles

Follow-up

Participants are monitored for recurrence-free survival and overall survival

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Capecitabine
  • Fluorouracil
  • Leucovorin
  • Leucovorin Calcium
  • Oxaliplatin
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (blood tested for ctDNA at baseline)Experimental Treatment6 Interventions
Group II: Arm I (blood stored and tested for ctDNA later)Active Control1 Intervention

Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Xeloda for:
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Approved in United States as Xeloda for:
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Approved in Canada as Xeloda for:
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Approved in Japan as Xeloda for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials
242
Recruited
105,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Xeloda (capecitabine) is an oral pro-drug that is effectively converted to 5-fluorouracil in the body, particularly in colorectal cancer, where the enzyme needed for activation is more active.
In large phase III trials, capecitabine demonstrated at least equal efficacy to the standard intravenous treatment of 5-FU and leucovorin, with better response rates and significantly lower toxicity, suggesting it may become the preferred treatment for colorectal cancer.
Xeloda in colorectal cancer.Cassidy, J.[2015]
Recent trials indicate that oral fluoropyrimidine agents like capecitabine (Xeloda) and UFT/leucovorin are as effective as standard intravenous 5-FU in treating advanced colorectal cancer, showing similar response rates and survival outcomes.
These oral agents also have the added benefit of reducing side effects such as neutropenia and stomatitis, making them a promising option for patients undergoing treatment for colorectal cancer.
Role of oral chemotherapy in colorectal cancer.Donehower, RC.[2015]
Capecitabine, an oral medication, showed at least equivalent efficacy to intravenous 5-FU plus leucovorin in treating metastatic colorectal cancer, with an overall response rate of 18.9% compared to 15.0% for 5-FU/LV among 602 patients.
Capecitabine had a more favorable safety profile, resulting in significantly lower rates of stomatitis and neutropenia, while being associated with a higher incidence of hand-foot syndrome, making it a convenient and effective alternative to traditional IV treatments.
Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study.Van Cutsem, E., Twelves, C., Cassidy, J., et al.[2022]

Citations

Xeloda in colorectal cancer. [2015]
Current status of capecitabine in the treatment of colorectal cancer. [2018]
Role of oral chemotherapy in colorectal cancer. [2015]
XELOX (capecitabine plus oxaliplatin): active first-line therapy for patients with metastatic colorectal cancer. [2022]
Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. [2022]
[Capecitabine--a review of its antitumor activity and toxicity in clinical studies]. [2015]
Capecitabine as first-line treatment in colorectal cancer. Pooled data from two large, phase III trials. [2019]
Fluoropyrimidines: a critical evaluation. [2017]
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