Trial · NCT02848079
TAS-OX for Refractory Metastatic Colon Cancer
NCT02848079, Phase 1, Phase 2, Completed, Yale University; results first posted 2021-07-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TAS-OX for Refractory Metastatic Colon Cancer. Trials, record NCT02848079. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02848079
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TAS-OX for Refractory Metastatic Colon Cancer
- NCT number
- NCT02848079
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Colorectal Neoplasms
- Interventions
- combined TAS-102 and TAS-OX
- First posted
- 2016-07-28
- Last updated
- 2021-07-20
- Results first posted
- 2021-07-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | up to 30 days following discontinuation of treatment | Overall Response Rate was measured by Response Evaluation Criteria In Solid Tumor (RECIST) 1.1 criteria. Tumors were assessed with CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.". |
| Secondary | Progression Free Survival | from the date of start of treatment to the date of first documented progression or any cause of death assessed up to 12 months. | Progression Free Survival was assessed according to RECIST criteria version 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Overall Survival | from the date of start of treatment to the date of any cause of death assessed up to 24 months. | Overall Survival was assessed by the time to death from start of study. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate | up to 30 days following discontinuation of treatment | Intention-to-treat (ITT) | months | MEDIAN |
| SECONDARY | Progression Free Survival | from the date of start of treatment to the date of first documented progression or any cause of death assessed up to 12 months. | Intention-to-treat (ITT) | months | MEDIAN |
| SECONDARY | Overall Survival | from the date of start of treatment to the date of any cause of death assessed up to 24 months. | Intention-to-Treat (ITT) | months | MEDIAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | Combined TAS-102 and TAS-OX | 2.4 | 95% Confidence Interval 0 to 12.9 | months | |
| Progression Free Survival | Combined TAS-102 and TAS-OX | 2.7 | 95% Confidence Interval 2.4 to 4.8 | months | |
| Overall Survival | Combined TAS-102 and TAS-OX | 6.8 | 95% Confidence Interval 5.4 to 10.0 | months |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combined TAS-102 and TAS-OX | 41 | |
| Overall Study | Receieved Study Treatment | Combined TAS-102 and TAS-OX | 41 | |
| Overall Study | Discontinued | Combined TAS-102 and TAS-OX | 41 | |
| Overall Study | COMPLETED | Combined TAS-102 and TAS-OX | 41 | |
| Overall Study | NOT COMPLETED | Combined TAS-102 and TAS-OX | 0 |
Source ClinicalTrials.gov
Adverse events54
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 | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Combined TAS-102 and TAS-OX | 9 | 41 | |
| other | Vomiting | Gastrointestinal disorders | Combined TAS-102 and TAS-OX | 12 | 41 | 20 |
| other | Peripheral sensory neuropathy | Nervous system disorders | Combined TAS-102 and TAS-OX | 6 | 41 | |
| other | Anorexia | General disorders | Combined TAS-102 and TAS-OX | 16 | 41 | 21 |
| other | Anemia | Blood and lymphatic system disorders | Combined TAS-102 and TAS-OX | 25 | 41 | 46 |
| other | Neutrophil count decrease | Investigations | Combined TAS-102 and TAS-OX | 15 | 41 | 49 |
| other | Platelet count decrease | Blood and lymphatic system disorders | Combined TAS-102 and TAS-OX | 13 | 41 | |
| other | White blood cell decreased | Investigations | Combined TAS-102 and TAS-OX | 14 | 41 | 51 |
| other | Alkaline phosphatase increased | Blood and lymphatic system disorders | Combined TAS-102 and TAS-OX | 20 | 41 | 28 |
| other | Abdominal Pain | Gastrointestinal disorders | Combined TAS-102 and TAS-OX | 11 | 41 | 14 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combined TAS-102 and TAS-OX | 37 | 41 |
| Total, other adverse events | Combined TAS-102 and TAS-OX | 41 | 41 |
| Total, serious adverse events | Combined TAS-102 and TAS-OX | 8 | 41 |
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.
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/NCT02848079
GET https://conductscience.org/api/trials/v1/NCT02848079/events?page=2