Trial · NCT03844620
Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer
NCT03844620, Phase 2, Active not recruiting, M.D. Anderson Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer. Trials, record NCT03844620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03844620
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer
- NCT number
- NCT03844620
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Refractory Colorectal Carcinoma, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8
- Interventions
- Best Practice, Laboratory Procedure, Quality-of-Life Assessment, Questionnaire Administration, Regorafenib, Trifluridine and Tipiracil Hydrochloride
- First posted
- 2019-02-18
- Last updated
- 2026-08-07
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Early change in circulating tumor-derived deoxyribonucleic acid (DNA) (ctDNA) as a predictor of radiographic progression (Arm II-SOC) | First 4 months after treatment initiation | Number of patients with rise in ctDNA level will be compared to Number of patients with progression of disease on scans. |
| Primary | Treatment-related adverse events (TRAEs) of interest (grade 3/4 toxicity, intolerable grade 2 toxicity, or any toxicity requiring dose reduction) between arms | First 4 months after treatment initiation | Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. To compare the proportions of patients who have experienced TRAEs of interest within the first 4 months between the two treatment arms, Fisher's exact test will be used. |
| Secondary | Mean patient-reported outcomes (PROs) score as per MD Anderson Symptom Inventory (MDASI-GI) | Up to 18 months | Mean PROs scores measured by MDASI-GI scales will be compared between arms |
| Secondary | Mean patient-reported outcomes (PROs) score as per PRO-CTCAE | Up to 18 months | Mean PROs scores measured by PRO-CTCAE scales will be compared between arms |
| Secondary | Percentage of patients with partial response (PR) | Up to 18 months | Percentage of patients with PR will be compared between arms |
| Secondary | Percentage of patients with stable disease (SD) | Up to 18 months | Percentage of patients with SD will be compared between arms |
| Secondary | Overall survival (OS) | Up to 18 months | OS will be compared between arms. |
| Secondary | Percentage of patients who present with events of special interest (ESIs) | Up to 18 months | Percentage of patients who present with ESIs \[described as either Hospitalizations/emergency room visits or need for medical interventions (blood transfusions and IV hydration)\] will be compared between arms |
| Secondary | Cost measured in US dollars | Up to 18 months | Cost measured in US dollars will be compared between arms |
| Secondary | Median time to performance status deterioration | Up to 18 months | Will be compared between arms. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03844620
GET https://conductscience.org/api/trials/v1/NCT03844620/registered