Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

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

NCT04068103 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Capecitabine
  • DRUG Fluorouracil
  • DRUG Leucovorin
  • DRUG Oxaliplatin
  • DRUG Leucovorin Calcium

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine — Anchorage
  • Anchorage Radiation Therapy Center — Anchorage
  • Alaska Breast Care and Surgery LLC — Anchorage
  • Alaska Oncology and Hematology LLC — Anchorage
  • Alaska Women's Cancer Care — Anchorage
  • Anchorage Oncology Centre — Anchorage
  • Katmai Oncology Group — Anchorage
  • Providence Alaska Medical Center — Anchorage
  • Fairbanks Memorial Hospital — Fairbanks

Arizona

  • Kingman Regional Medical Center — Kingman
  • Cancer Center at Saint Joseph's — Phoenix
  • Banner University Medical Center - Tucson — Tucson
  • University of Arizona Cancer Center-North Campus — Tucson

Arkansas

  • Mercy Hospital Fort Smith — Fort Smith
  • CHI Saint Vincent Cancer Center Hot Springs — Hot Springs
  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro

Alabama

  • University of Alabama at Birmingham Cancer Center — Birmingham
  • University of South Alabama Mitchell Cancer Institute — Mobile

California

  • Kaiser Permanente-Anaheim — Anaheim
  • Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande

Trial Details

FieldValue
Enrollment Target 635 participants
Start Date 2019-12-16
Est. Completion 2026-06-21
Phase Phase 2

Sponsor

NRG Oncology

162 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04068103

The ClinicalTrials.gov registry entry for NCT04068103 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 635 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NRG Oncology, which has 162 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Colon Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions — of which Capecitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04068103 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Alaska, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04068103 about?

NCT04068103 is a clinical study titled "Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery". 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 mea...

What is the current status of trial NCT04068103?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 635 participants. The study started on 2019-12-16. Estimated completion is 2026-06-21.

What conditions does trial NCT04068103 study?

This clinical trial studies the following conditions: Colon Adenocarcinoma, Stage IIA Colon Cancer AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04068103?

The interventions under investigation include: Capecitabine (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Leucovorin Calcium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04068103?

This trial is sponsored by NRG Oncology, which has 162 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04068103 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial