Capecitabine for Cancer of Colon

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Saint Francis Cancer Center, Colorado Springs, CO
Cancer of Colon+2 More
Capecitabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests how well ctDNA testing in the blood predicts 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. The primary treatment in this trial is fluorouracil, which is used to treat cancer of the colon. This treatment has previously been approved by the FDA for a different condition. There will be no patients in this trial who receive a placebo.

Eligible Conditions

  • Cancer of Colon
  • Adenocarcinoma
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Up to 3 years

Month 6
Clearance of circulating tumor deoxyribonucleic acid (ctDNA) (to undetectable levels) for the "baseline ctDNA detected" patient subset (Phase II)
Year 3
Recurrence-free survival (RFS) the "baseline ctDNA detected" patient subset (Phase III)
Up to 3 years
Compliance with adjuvant chemotherapy and/or active surveillance
Cost effectiveness of the use of ctDNA versus standard of care
Genomic profiles
Incidence (presence or absence) of ctDNA in blood following resection of stage II colon cancer
Overall survival (OS)
Quantitative ctDNA levels
RFS
Time to recurrence (TTR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm I (blood stored and tested for ctDNA later)
1 of 2
Arm II (blood tested for ctDNA at baseline)
1 of 2
Active Control
Experimental Treatment

1408 Total Participants · 2 Treatment Groups

Primary Treatment: Capecitabine · No Placebo Group · Phase 2 & 3

Arm II (blood tested for ctDNA at baseline)Experimental Group · 6 Interventions: Leucovorin Calcium, Leucovorin, Capecitabine, Fluorouracil, Patient Observation, Oxaliplatin · Intervention Types: Drug, Drug, Drug, Drug, Other, Drug
Arm I (blood stored and tested for ctDNA later)
Other
ActiveComparator Group · 1 Intervention: Patient Observation · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calcium
Not yet FDA approved
Leucovorin
FDA approved
Capecitabine
FDA approved
Fluorouracil
FDA approved
Oxaliplatin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Closest Location: Saint Francis Cancer Center · Colorado Springs, CO
Photo of colorado 1Photo of colorado 2Photo of colorado 3
2016First Recorded Clinical Trial
0 TrialsResearching Cancer of Colon
46 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,292,379 Total Patients Enrolled
1 Trials studying Cancer of Colon
500 Patients Enrolled for Cancer of Colon
NRG OncologyLead Sponsor
215 Previous Clinical Trials
92,078 Total Patients Enrolled
Van K MorrisPrincipal InvestigatorNRG Oncology
3 Previous Clinical Trials
196 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Appropriate for active surveillance (i.e.
The tissue must be available for molecular diagnostics and confirmatory profiling.
Platelet count must be > 100,000/mm^3 (within 28 days before randomization).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.