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Trial · NCT04294264

TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer

NCT04294264, Phase 2, Active not recruiting, Rutgers, The State University of New Jersey

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer. Trials, record NCT04294264. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04294264

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Trial

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

Title
TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer
NCT number
NCT04294264
Status
Active not recruiting
Phases
Phase 2
Enrollment
50 participants, estimated
Lead sponsor
Rutgers, The State University of New Jersey
Conditions
Metastatic Colorectal Carcinoma, Recurrent Colon Carcinoma, Refractory Colorectal Carcinoma, Stage IV Colon Cancer AJCC v7, Stage IVA Colon Cancer AJCC v7, Stage IVB Colon Cancer AJCC v7
Interventions
Oxaliplatin, Trifluridine and Tipiracil Hydrochloride
First posted
2020-03-04
Last updated
2024-11-18

Source ClinicalTrials.gov

Registered outcomes6

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

ListOutcomeTime frameDescription
PrimaryOverall response rateUp to 2 years
Response rate is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) by investigator assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Response rate will be calculated by dose level. Descriptive statistics will be used to analyze efficacy data using historical data as reference.
SecondaryProgression free survivalFrom the date of start of treatment to the date of first documented progression or any cause of death during the study, assessed up to 2 years
Progression will be assessed by a computed tomography CT scan according to RECIST criteria version 1.1. This criterion will be estimated by the Kaplan-Meier method. Patients who have not progressed or died at the time of analysis will be censored at the time of their latest follow-up with clinically stable disease.
SecondaryOverall survivalUp to 2 years
SecondaryDisease control rateUp to 2 years
SecondaryDuration of responseUp to 2 yearsResponse rate will be calculated by dose level. Descriptive statistics will be used to analyze efficacy data using historical data as reference.
SecondaryIncidence of adverse eventsUp to 28 days post treatment
All recorded adverse events will be listed and tabulated by system organ class and dose level. Will utilize the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) version 5.0 for toxicity and adverse event reporting.

Outcomes0

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
P30CA072720Cancer Center Support GrantLIBUTTI, STEVEN K.RUTGERS BIOMEDICAL AND HEALTH SCIENCESNATIONAL CANCER INSTITUTE1997 to 2025

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/NCT04294264

GET https://conductscience.org/api/trials/v1/NCT04294264/registered