Trial · NCT04068103
Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery
NCT04068103, Phase 2, Phase 3, Active not recruiting, NRG Oncology; results first posted 2025-04-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery. Trials, record NCT04068103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04068103
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery
- NCT number
- NCT04068103
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 635 participants, actual
- Lead sponsor
- NRG Oncology
- Conditions
- Colon Adenocarcinoma, Stage IIA Colon Cancer AJCC v8
- Interventions
- Capecitabine, Fluorouracil, Leucovorin, Leucovorin Calcium, Oxaliplatin, Patient Observation
- First posted
- 2019-08-28
- Last updated
- 2025-05-07
- Results first posted
- 2025-04-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clearance of Circulating Tumor Deoxyribonucleic Acid (ctDNA) (to Undetectable Levels) for the "Baseline ctDNA Detected" Patient Subset (Phase II) | Baseline up to 6 months | 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. |
| Primary | Recurrence-free Survival (RFS) the "Baseline ctDNA Detected" Patient Subset (Phase III) | Time to recurrence or death, assessed up to 3 years | RFS will be compared by treatment arm using the logrank test with no stratification in the intent to treat (ITT) cohort. Kaplan Meier curves will be computed to describe the distribution of time to event. A summary hazard ratio and associated confidence interval will be computed from a Cox model with treatment arm as the only covariate. |
| Secondary | RFS | Up to 3 years | According to ctDNA marker status and treatment. Kaplan Meier analyses to describe the distribution of time to event for each marker-treatment combination. |
| Secondary | Overall Survival (OS) | Up to 3 years | According to ctDNA marker status and treatment. Kaplan Meier analyses to describe the distribution of time to event for each marker-treatment combination. The unstratified logrank test will be used to compare treatments for patients ?ctDNA positive? at baseline and a Cox model will estimate the hazard ratio. |
| Secondary | Time to Recurrence (TTR) | Up to 3 years | According to ctDNA marker status and treatment. Kaplan Meier analyses to describe the distribution of time to event for each marker-treatment combination. The unstratified logrank test will be used to compare treatments for patients ?ctDNA positive? at baseline and a Cox model will estimate the hazard ratio. |
| Secondary | Compliance With Adjuvant Chemotherapy and/or Active Surveillance | Up to 3 years | The duration of chemotherapy will be categorized as none, less than 3 months, and at least 3 months by treatment arm and baseline ctDNA status. Arms will be compared by a chi square test within each baseline ctDNA status. |
| Secondary | Incidence (Presence or Absence) of ctDNA in Blood Following Resection of Stage II Colon Cancer | Up to 3 years |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clearance of Circulating Tumor Deoxyribonucleic Acid (ctDNA) (to Undetectable Levels) for the Baseline ctDNA Detected Patient Subset (Phase II) | Baseline up to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Recurrence-free Survival (RFS) the Baseline ctDNA Detected Patient Subset (Phase III) | Time to recurrence or death, assessed up to 3 years | The primary aim for the Phase III portion of the study will not be reported because the study never went to Phase III. | ||
| SECONDARY | RFS | Up to 3 years | |||
| SECONDARY | Overall Survival (OS) | Up to 3 years | |||
| SECONDARY | Time to Recurrence (TTR) | Up to 3 years | |||
| SECONDARY | Compliance With Adjuvant Chemotherapy and/or Active Surveillance | Up to 3 years | |||
| SECONDARY | Incidence (Presence or Absence) of ctDNA in Blood Following Resection of Stage II Colon Cancer | Up to 3 years |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clearance of Circulating Tumor Deoxyribonucleic Acid (ctDNA) (to Undetectable Levels) for the Baseline ctDNA Detected Patient Subset (Phase II) | Arm I (Blood Stored and Tested for ctDNA Later) | Cleared ctDNA | 3 | Participants | |
| Clearance of Circulating Tumor Deoxyribonucleic Acid (ctDNA) (to Undetectable Levels) for the Baseline ctDNA Detected Patient Subset (Phase II) | Arm II (Blood Tested for ctDNA at Baseline) | Cleared ctDNA | 1 | Participants | |
| Clearance of Circulating Tumor Deoxyribonucleic Acid (ctDNA) (to Undetectable Levels) for the Baseline ctDNA Detected Patient Subset (Phase II) | Arm I (Blood Stored and Tested for ctDNA Later) | Failed to clear ctDNA | 4 | Participants | |
| Clearance of Circulating Tumor Deoxyribonucleic Acid (ctDNA) (to Undetectable Levels) for the Baseline ctDNA Detected Patient Subset (Phase II) | Arm II (Blood Tested for ctDNA at Baseline) | Failed to clear ctDNA | 8 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Blood Stored and Tested for ctDNA Later) | 318 | |
| Overall Study | STARTED | Arm II (Blood Tested for ctDNA at Baseline) | 317 | |
| Overall Study | COMPLETED | Arm I (Blood Stored and Tested for ctDNA Later) | 318 | |
| Overall Study | COMPLETED | Arm II (Blood Tested for ctDNA at Baseline) | 317 | |
| Overall Study | NOT COMPLETED | Arm I (Blood Stored and Tested for ctDNA Later) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Blood Tested for ctDNA at Baseline) | 0 |
Source ClinicalTrials.gov
Adverse events158
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Arm I (Blood Stored and Tested for ctDNA Later) | 0 | 0 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm II (Blood Tested for ctDNA at Baseline) | 4 | 15 | |
| other | Alanine aminotransferase increased | Investigations | Arm I (Blood Stored and Tested for ctDNA Later) | 0 | 0 | |
| other | Alanine aminotransferase increased | Investigations | Arm II (Blood Tested for ctDNA at Baseline) | 3 | 15 | |
| other | Alkaline phosphatase increased | Investigations | Arm I (Blood Stored and Tested for ctDNA Later) | 0 | 0 | |
| other | Alkaline phosphatase increased | Investigations | Arm II (Blood Tested for ctDNA at Baseline) | 4 | 15 | |
| other | Allergic reaction | Immune system disorders | Arm I (Blood Stored and Tested for ctDNA Later) | 0 | 0 | |
| other | Allergic reaction | Immune system disorders | Arm II (Blood Tested for ctDNA at Baseline) | 1 | 15 | |
| other | Anemia | Blood and lymphatic system disorders | Arm I (Blood Stored and Tested for ctDNA Later) | 0 | 0 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Blood Tested for ctDNA at Baseline) | 3 | 15 |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Blood Stored and Tested for ctDNA Later) | 8 | 318 |
| Total, all-cause mortality | Arm II (Blood Tested for ctDNA at Baseline) | 6 | 317 |
| Total, other adverse events | Arm I (Blood Stored and Tested for ctDNA Later) | 0 | 0 |
| Total, other adverse events | Arm II (Blood Tested for ctDNA at Baseline) | 15 | 15 |
| Total, serious adverse events | Arm I (Blood Stored and Tested for ctDNA Later) | 0 | 0 |
| Total, serious adverse events | Arm II (Blood Tested for ctDNA at Baseline) | 3 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Blood Stored and Tested for ctDNA Later) vs Arm II (Blood Tested for ctDNA at Baseline): deaths from any cause |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04068103
GET https://conductscience.org/api/trials/v1/NCT04068103/events?page=2