Trial · NCT01913639

FOLFOX Plus Regorafenib in Patients With Unresectable or Metastatic Esophagogastric Cancer

NCT01913639, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2020-05-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. FOLFOX Plus Regorafenib in Patients With Unresectable or Metastatic Esophagogastric Cancer. Trials, record NCT01913639. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01913639

On this page

Trial

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

Title: FOLFOX Plus Regorafenib in Patients With Unresectable or Metastatic Esophagogastric Cancer
NCT number: NCT01913639
Status: Completed
Phases: Phase 2
Enrollment: 39 participants, actual
Lead sponsor: Memorial Sloan Kettering Cancer Center
Conditions: Esophageal Cancer, Gastric Cancer
Interventions: Regorafenib, 5-Fluorouracil, Leucovorin, Oxaliplatin
First posted: 2013-08-01
Last updated: 2020-05-15
Results first posted: 2020-05-15

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)	6 months
Secondary	Overall Survival (OS)	2 years	Overall survival will be measured from the start of treatment to death or last follow-up and will be estimated using the Kaplan-Meier method
Secondary	Overall Response Rate	4 weeks	This is defined as the percentage of patients who have achieved either an objective complete or partial target lesion response that is confirmed on the RECIST 1.1 criteria. Complete or partial responses will be confirmed with repeat CT evaluation after 4 weeks.
Secondary	Participants Evaluated for Toxicity	1 year	Adverse events will be determined as per the NCI Common Toxicity Criteria, version 4.0. Toxicity during cycle 1 and subsequent cycles will be reported.

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)	6 months	percentage of participants	NUMBER
SECONDARY	Overall Survival (OS)	2 years	months	MEDIAN
SECONDARY	Overall Response Rate	4 weeks	percentage of participants with CR or PR	NUMBER
SECONDARY	Participants Evaluated for Toxicity	1 year	Participants	COUNT_OF_PARTICIPANTS

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)	FOLFOX Plus Regorafenib	53	95% Confidence Interval 38 to 71	percentage of participants
Overall Survival (OS)	FOLFOX Plus Regorafenib	14.2	95% Confidence Interval 8.1 to 20.7	months
Overall Response Rate	FOLFOX Plus Regorafenib	54	95% Confidence Interval 37 to 70	percentage of participants with CR or PR
Participants Evaluated for Toxicity	FOLFOX Plus Regorafenib	39		Participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	FOLFOX Plus Regorafenib	39
Overall Study	COMPLETED	FOLFOX Plus Regorafenib	36
Overall Study	NOT COMPLETED	FOLFOX Plus Regorafenib	3

Source ClinicalTrials.gov

Adverse events94

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	Fatigue	General disorders	FOLFOX Plus Regorafenib	31	39
other	Anemia	Blood and lymphatic system disorders	FOLFOX Plus Regorafenib	28	39
other	White blood cell decreased	Investigations	FOLFOX Plus Regorafenib	28	39
other	Peripheral sensory neuropathy	Nervous system disorders	FOLFOX Plus Regorafenib	27	39
other	Platelet count decreased	Investigations	FOLFOX Plus Regorafenib	27	39
other	Hypertension	Vascular disorders	FOLFOX Plus Regorafenib	25	39
other	Nausea	Gastrointestinal disorders	FOLFOX Plus Regorafenib	23	39
other	Neutrophil count decreased	Investigations	FOLFOX Plus Regorafenib	23	39
other	Alanine aminotransferase increased	Investigations	FOLFOX Plus Regorafenib	21	39
other	Aspartate aminotransferase increased	Investigations	FOLFOX Plus Regorafenib	20	39

1 to 10 of 94Source ClinicalTrials.gov

See all 94 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	FOLFOX Plus Regorafenib	30	39
Total, other adverse events	FOLFOX Plus Regorafenib	36	39
Total, serious adverse events	FOLFOX Plus Regorafenib	17	39

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/NCT01913639

GET https://conductscience.org/api/trials/v1/NCT01913639/events?page=2

API reference For AI assistants