Trial · NCT04104139
TAS-102 With Concurrent Radiation for the Treatment of Untreated Resectable Stage II-III Rectal Cancer
NCT04104139, Phase 1, Completed, OHSU Knight Cancer Institute
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. TAS-102 With Concurrent Radiation for the Treatment of Untreated Resectable Stage II-III Rectal Cancer. Trials, record NCT04104139. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04104139
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TAS-102 With Concurrent Radiation for the Treatment of Untreated Resectable Stage II-III Rectal Cancer
- NCT number
- NCT04104139
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 19 participants, actual
- Lead sponsor
- OHSU Knight Cancer Institute
- Conditions
Rectal Adenocarcinoma, Stage IIA Rectal Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8, Stage IIIC Rectal Cancer AJCC v8
- Interventions
- 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy, Trifluridine and Tipiracil Hydrochloride
- First posted
- 2019-09-26
- Last updated
- 2026-08-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of dose limiting toxicity (DLT)s for TAS-102 at the maximum tolerated dose (MTD) | Up to end of week 8, or start of fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or capecitabine/oxaliplatin (CAPOX) chemotherapy, whichever occurs first | Will be assessed through the Bayesian optimal interval design and will be determined by the proportion of grade 3 or higher adverse events during chemo-radiation therapy (CRT) with TAS-102 at the MTD by allowing no more than 30% DLT. The proportion will be descriptively noted. |
| Secondary | Incidence of adverse events (AEs) (all grade) for TAS-102 concurrent with radiation therapy (RT) | Up to start of FOLFOX or CAPOX (up to 8 weeks) | Descriptive statistics of safety will be presented using National cancer Institute Common Terminology Criteria for Adverse Events version 5.0., with AEs tabulated by the MedDRA preferred term and system organ class. The incidence of AEs (all grades) for TAS-102 with concurrent RT will be assessed using the CRT analysis set. |
| Secondary | Incidence of grade 3 or higher treatment emergent adverse events (TEAEs) during FOLFOX or CAPOX treatment | Up to end of FOLFOX or CAPOX (up to 16 weeks) | The incidence of grade 3 or higher TEAEs during FOLFOX or CAPOX chemotherapy will be assessed using the FOLFOX/CAPOX analysis set. |
| Other | Rate of complete response (CR) by magnetic resonance imaging (MRI) after chemo-radiation therapy (CRT) | Prior to starting FOLFOX or CAPOX regimen (up to 8 weeks) | MRI report after CRT will be collected from medical records. Discrepancies will be resolved with the diagnostic radiology investigators of the research team. Complete response based on MRI will be tabulated as proportions and analyzed descriptively using the CRT analysis sets. |
| Other | Rate of CR by endoscopic exam after CRT | Prior to starting FOLFOX or CAPOX regimen (up to 8 weeks) | Endoscopic exam report after CRT will be collected from medical records (as available). Discrepancies will be resolved with the surgical oncology investigators of the research team. Complete response based on endoscopic exam will be tabulated as proportions and analyzed descriptively using the CRT analysis sets. |
| Other | Rate of clinical complete response (cCR) by MRI and endoscopic response after CRT | Prior to starting FOLFOX or CAPOX regimen (up to 8 weeks) | cCR requires CR for MRI and CR for endoscopic responses. The number of cCR after CRT will be tabulated as proportions using the CRT analysis sets, respectively. |
| Other | Rate of CR by MRI after CRT and FOLFOX or CAPOX | At end of chemotherapy visit (up to 21 weeks) | MRI report after CRT + FOLFOX or CAPOX will be collected from medical records. Discrepancies will be resolved with the diagnostic radiology investigators of the research team. Complete response based on MRI will be tabulated as proportions and analyzed descriptively using the CRT and the FOLFOX/CAPOX analysis sets, respectively. |
| Other | Rate of CR by endoscopic exam after CRT and FOLFOX or CAPOX | At end of chemotherapy visit (up to 21 weeks) | Endoscopic exam report after CRT + FOLFOX or CAPOX will be collected from medical records (as available). Discrepancies will be resolved with the surgical oncology investigators of the research team. Complete response based on endoscopic exam will be tabulated as proportions and analyzed descriptively using the CRT and the FOLFOX/CAPOX analysis sets, respectively. |
| Other | Rate of cCR by MRI and endoscopic response after CRT and FOLFOX or CAPOX | At end of chemotherapy visit (up to 21 weeks) | cCR requires CR for MRI and CR for endoscopic responses. The number of cCR after CRT and after CRT + FOLFOX or CAPOX will be tabulated as proportions using the CRT and the FOLFOX/CAPOX analysis sets, respectively. |
| Other | Rate of pathologic complete response after standard total mesorectal excision (TME) | At resection (up to 29 weeks) | Pathology report after standard TME will be collected from medical records. Discrepancies will be resolved with the surgical oncology and pathology investigators of the research team. Complete response based on pathology will be tabulated as proportions and analyzed descriptively using the TME population. |
Source ClinicalTrials.gov
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41781240 | RESULT |
Source PubMed
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA069533 | OHSU Knight Cancer Institute | KUMMAR, SHIVAANI | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1997 to 2025 |
Source NIH RePORTER
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/NCT04104139
GET https://conductscience.org/api/trials/v1/NCT04104139/registered