Trial Outcomes & Findings for Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery (NCT NCT04068103)

Last Updated: 2025-05-07

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2/PHASE3

Target enrollment

635 participants

Primary outcome timeframe

Baseline up to 6 months

Results posted on

2025-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Blood Stored and Tested for ctDNA Later) Patients undergo active surveillance. Patient Observation: Undergo active surveillance	Arm II (Blood Tested for ctDNA at Baseline) 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. Capecitabine: Given PO Fluorouracil: Given IV Leucovorin: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Give IV Patient Observation: Undergo active surveillance
Overall Study STARTED	318	317
Overall Study COMPLETED	318	317
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Blood Stored and Tested for ctDNA Later) n=318 Participants Patients undergo active surveillance. Patient Observation: Undergo active surveillance	Arm II (Blood Tested for ctDNA at Baseline) n=317 Participants 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. Capecitabine: Given PO Fluorouracil: Given IV Leucovorin: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Give IV Patient Observation: Undergo active surveillance	Total n=635 Participants Total of all reporting groups
Age, Customized Less than 60 years	143 Participants n=93 Participants	141 Participants n=4 Participants	284 Participants n=27 Participants
Age, Customized Greater than or equal to 60 years	175 Participants n=93 Participants	176 Participants n=4 Participants	351 Participants n=27 Participants
Sex: Female, Male Female	142 Participants n=93 Participants	153 Participants n=4 Participants	295 Participants n=27 Participants
Sex: Female, Male Male	176 Participants n=93 Participants	164 Participants n=4 Participants	340 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Asian	17 Participants n=93 Participants	16 Participants n=4 Participants	33 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	25 Participants n=93 Participants	18 Participants n=4 Participants	43 Participants n=27 Participants
Race/Ethnicity, Customized White	257 Participants n=93 Participants	262 Participants n=4 Participants	519 Participants n=27 Participants
Race/Ethnicity, Customized Unknown or Not Reported for Race	18 Participants n=93 Participants	20 Participants n=4 Participants	38 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	26 Participants n=93 Participants	34 Participants n=4 Participants	60 Participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	283 Participants n=93 Participants	270 Participants n=4 Participants	553 Participants n=27 Participants
Race/Ethnicity, Customized Unknown or Not Reported Ethnicity	9 Participants n=93 Participants	13 Participants n=4 Participants	22 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline up to 6 months

Outcome measures

Outcome measures
Measure	Arm I (Blood Stored and Tested for ctDNA Later) n=7 Participants Patients undergo active surveillance. Patient Observation: Undergo active surveillance	Arm II (Blood Tested for ctDNA at Baseline) n=9 Participants 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. Capecitabine: Given PO Fluorouracil: Given IV Leucovorin: Given IV Leucovorin Calcium: Given IV Oxaliplatin: Give IV Patient Observation: Undergo active surveillance
Clearance of Circulating Tumor Deoxyribonucleic Acid (ctDNA) (to Undetectable Levels) for the "Baseline ctDNA Detected" Patient Subset (Phase II) Failed to clear ctDNA	4 Participants	8 Participants
Clearance of Circulating Tumor Deoxyribonucleic Acid (ctDNA) (to Undetectable Levels) for the "Baseline ctDNA Detected" Patient Subset (Phase II) Cleared ctDNA	3 Participants	1 Participants

PRIMARY outcome

Timeframe: Time to recurrence or death, assessed up to 3 years

Population: The primary aim for the Phase III portion of the study will not be reported because the study never went to Phase III.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Blood Stored and Tested for ctDNA Later)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 8 deaths

Arm II (Blood Tested for ctDNA at Baseline)

Serious events: 3 serious events

Other events: 15 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Blood Stored and Tested for ctDNA Later) Arm I (blood stored and tested for ctDNA later). AEs were NOT assessed in this arm.	Arm II (Blood Tested for ctDNA at Baseline) n=15 participants at risk Arm II (blood tested for ctDNA at baseline). Positive ctDNA and Treated assessed in this arm.
Gastrointestinal disorders Abdominal pain	— 0/0 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.	6.7% 1/15 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.
Gastrointestinal disorders Diarrhea	— 0/0 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.	13.3% 2/15 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	— 0/0 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.	6.7% 1/15 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.
Investigations Neutrophil count decreased	— 0/0 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.	6.7% 1/15 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.
Gastrointestinal disorders Typhlitis	— 0/0 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.	6.7% 1/15 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.
Investigations White blood cell decreased	— 0/0 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.	6.7% 1/15 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.
Infections and infestations Enterocolitis infectious	— 0/0 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.	6.7% 1/15 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.
General disorders Non-cardiac chest pain	— 0/0 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.	6.7% 1/15 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.
Gastrointestinal disorders Small intestinal mucositis	— 0/0 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.	6.7% 1/15 • AEs assessed during and up to 30 days after therapy, about 28 weeks. Participants at Risk includes any patient who submitted an AE form. All patients were at risk for All Cause Mortality. Only Treated patients were at risk for AEs.

Other adverse events

Additional Information

Director, Department of Regulatory Affairs

NRG Oncology

Phone: 412-339-5300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60