Trial · NCT03099486

Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC

NCT03099486, Phase 2, Terminated, Fox Chase Cancer Center; results first posted 2022-02-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC. Trials, record NCT03099486. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03099486

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC
NCT number: NCT03099486
Status: Terminated
Phases: Phase 2
Enrollment: 2 participants, actual
Lead sponsor: Fox Chase Cancer Center
Conditions: Colorectal Cancer
Interventions: Regorafenib, 5-FU, Leucovorin
First posted: 2017-04-04
Last updated: 2022-02-07
Results first posted: 2022-02-07

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival (PFS) at 2 Months	2 months	PFS at 2 months in mCRC patients who progress on regorafenib monotherapy and are treated with regorafenib and 5-FU/LV combination therapy.
Secondary	Overall Survival Rate	1 years	Overall survival will be calculated from the day of first treatment until death
Secondary	Best Overall Response	1-2 years	This will be calculated from the day of first treatment dose until disease progression or death, whichever occurs earlier
Secondary	Number of Toxicities Due to Regorafenib and 5-FU/LV Combination Therapy	1-2 years	Number of toxicities due to combination therapy will be summarized by frequencies and grades of toxicities due to the combination therapy according to CTCAE 4.03 criteria

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Progression Free Survival (PFS) at 2 Months	2 months	months	MEDIAN
SECONDARY	Overall Survival Rate	1 years	months	MEDIAN
SECONDARY	Best Overall Response	1-2 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Toxicities Due to Regorafenib and 5-FU/LV Combination Therapy	1-2 years	toxicities	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression Free Survival (PFS) at 2 Months	Regorafenib + 5FU/LV Treatment Arm	NA	95% Confidence Interval NA to NA	months
Overall Survival Rate	Regorafenib + 5FU/LV Treatment Arm	NA	95% Confidence Interval NA to NA	months
Best Overall Response	Regorafenib + 5FU/LV Treatment Arm	NA		Participants
Number of Toxicities Due to Regorafenib and 5-FU/LV Combination Therapy	Regorafenib + 5FU/LV Treatment Arm	NA	95% Confidence Interval NA to NA	toxicities

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Regorafenib + 5FU/LV Treatment Arm	2
Overall Study	COMPLETED	Regorafenib + 5FU/LV Treatment Arm	2
Overall Study	NOT COMPLETED	Regorafenib + 5FU/LV Treatment Arm	0

Source ClinicalTrials.gov

Adverse events45

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
other	Diarrhea	Gastrointestinal disorders	Regorafenib + 5FU/LV Treatment Arm	2	2
other	Nausea	Gastrointestinal disorders	Regorafenib + 5FU/LV Treatment Arm	2	2
other	Vomiting	Gastrointestinal disorders	Regorafenib + 5FU/LV Treatment Arm	2	2
other	Abdominal Pain	Gastrointestinal disorders	Regorafenib + 5FU/LV Treatment Arm	1	2
other	Bloating	Gastrointestinal disorders	Regorafenib + 5FU/LV Treatment Arm	1	2
other	Small Intestinal Obstruction	Gastrointestinal disorders	Regorafenib + 5FU/LV Treatment Arm	1	2
other	Fatigue	General disorders	Regorafenib + 5FU/LV Treatment Arm	2	2
other	Chills	General disorders	Regorafenib + 5FU/LV Treatment Arm	1	2
other	Edema Limbs	General disorders	Regorafenib + 5FU/LV Treatment Arm	1	2
other	Fever	General disorders	Regorafenib + 5FU/LV Treatment Arm	1	2

1 to 10 of 45Source ClinicalTrials.gov

See all 45 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regorafenib + 5FU/LV Treatment Arm	2	2
Total, other adverse events	Regorafenib + 5FU/LV Treatment Arm	2	2
Total, serious adverse events	Regorafenib + 5FU/LV Treatment Arm	1	2

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

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.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03099486

GET https://conductscience.org/api/trials/v1/NCT03099486/events?page=2

API reference For AI assistants