Trial · NCT02788006

Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .

NCT02788006, Phase 2, Completed, Federation Francophone de Cancerologie Digestive; results first posted 2024-02-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma . Trials, record NCT02788006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02788006

On this page

Trial

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

Title: Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .
NCT number: NCT02788006
Status: Completed
Phases: Phase 2
Enrollment: 43 participants, actual
Lead sponsor: Federation Francophone de Cancerologie Digestive
Conditions: Colorectal Adenocarcinoma
Interventions: Regorafenib 160 mg
First posted: 2016-06-02
Last updated: 2024-02-23
Results first posted: 2024-02-23

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Percentage of Patients With a Tumoral Control Rate at 2 Months	2 months after the start of treatment	Tumor control rate is defined as the percentage of patients with complete tumor response, partial tumor response, or tumor stability on regorafenib therapy at 2 months after initiation of therapy as determined by the investigator per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.1 criteria) for target lesions and assessed by CT-Scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stability : neither complete or partial response nor progression.
Secondary	Overall Survival	Up to approximatively 1 year after the end of the treatment	Overall survival was defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news wastaken into account. Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Patients With a Tumoral Control Rate at 2 Months	2 months after the start of treatment		Percentage of patients	NUMBER
SECONDARY	Overall Survival	Up to approximatively 1 year after the end of the treatment	All patients included in the study and who have been treated with regorafenib	months	MEDIAN

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Percentage of Patients With a Tumoral Control Rate at 2 Months	Regorafenib 160 mg		31.4	90% Confidence Interval 18.7 to 46.6	Percentage of patients
Overall Survival	Regorafenib 160 mg		7.5	95% Confidence Interval 5.5 to 10.6	months

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Regorafenib 160 mg	43
Overall Study	COMPLETED	Regorafenib 160 mg	42
Overall Study	NOT COMPLETED	Regorafenib 160 mg	1

Source ClinicalTrials.gov

Adverse events46

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	Aspartate aminotransferase increased	Investigations	Regorafenib 160 mg	21	42
other	Alanine aminotransferase increased	Investigations	Regorafenib 160 mg	12	42
other	Total Bilirubin increased	Investigations	Regorafenib 160 mg	22	42
other	Gamma-glutamyltransferase increased	Investigations	Regorafenib 160 mg	31	42
other	White blood cell count decreased	Investigations	Regorafenib 160 mg	4	42
other	Lipase increased	Investigations	Regorafenib 160 mg	7	42
other	Neutrophils decreased	Investigations	Regorafenib 160 mg	4	42
other	Lymphocytes decreased	Investigations	Regorafenib 160 mg	3	42
other	Phosphatases Alcalines increased	Investigations	Regorafenib 160 mg	21	42
other	Platelets decreased	Investigations	Regorafenib 160 mg	20	42

1 to 10 of 46Source ClinicalTrials.gov

See all 46 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regorafenib 160 mg	36	42
Total, other adverse events	Regorafenib 160 mg	42	42
Total, serious adverse events	Regorafenib 160 mg	17	42

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32334940	RESULT

Source PubMed

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/NCT02788006

GET https://conductscience.org/api/trials/v1/NCT02788006/events?page=2

API reference For AI assistants