Trial · NCT04417699

SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer

NCT04417699, Phase 2, Completed, Providence Health & Services; results first posted 2025-12-10

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer. Trials, record NCT04417699. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04417699

On this page

Trial

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

Title: SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer
NCT number: NCT04417699
Status: Completed
Phases: Phase 2
Enrollment: 13 participants, actual
Lead sponsor: Providence Health & Services
Conditions: Rectal Cancer
Interventions: TAS 102, Oxaliplatin
First posted: 2020-06-05
Last updated: 2025-12-10
Results first posted: 2025-12-10

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Neoadjuvant Response (NAR) Score	Through study completion, an average of 6 months	Determine whether pre-operative short-course radiation therapy (SRT) and 6 cycles of TASOX offers condensed radiation and total neoadjuvant therapy for intermediate risk rectal cancer. Measurement of efficacy is the NAR score, where the required elements of the NAR score are: clinical tumor stage (cT), pathologic tumor stage (pT), pathological nodal stage (pN). For patients with a cCR who opted for non-operative management, for the purposes of the NAR score, those patients were assigned a pT0 and pN0 score if they did not experience tumor regrowth or require subsequent TME surgical resection during the time of the study. The NAR score ranges from 0-100, where lower NAR scores are considered favorable as opposed to higher scores which would indicate a worse prognosis. NAR calculation as follows: NAR=\[5 pN- 3(cT-pT)+12\]\^2/9.61
Secondary	Safety and Tolerability	Through study completion, an average of 6 months	The secondary objective is to describe Incidence of Treatment-Emergent Adverse Events and surgery complications among treated subjects.

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	Neoadjuvant Response (NAR) Score	Through study completion, an average of 6 months		Calculated score	MEAN
SECONDARY	Safety and Tolerability	Through study completion, an average of 6 months		participants	NUMBER

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
Neoadjuvant Response (NAR) Score	TAS102 Plus Oxaliplatin		9.31	Standard Deviation 13.41	Calculated score
Safety and Tolerability	TAS102 Plus Oxaliplatin	Number of patients who experienced Grade 3 or 4 adverse events	7		participants
Safety and Tolerability	TAS102 Plus Oxaliplatin	Number of patients who experienced post-operative complications	0		participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	TAS102 Plus Oxaliplatin	13
Overall Study	COMPLETED	TAS102 Plus Oxaliplatin	13
Overall Study	NOT COMPLETED	TAS102 Plus Oxaliplatin	0

Source ClinicalTrials.gov

Adverse events62

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	Abdominal Cramping	Gastrointestinal disorders	TAS102 Plus Oxaliplatin	1	13	1
other	Abdominal Pain/Discomfort	Gastrointestinal disorders	TAS102 Plus Oxaliplatin	4	13	4
other	Anosmia	Nervous system disorders	TAS102 Plus Oxaliplatin	1	13	1
other	Alanine aminotransferase increase	Investigations	TAS102 Plus Oxaliplatin	2	13	4
other	Aspartate aminotransferase increase	Investigations	TAS102 Plus Oxaliplatin	2	13	3
other	Blurred vision	Eye disorders	TAS102 Plus Oxaliplatin	1	13	1
other	Cold sensitivity	General disorders	TAS102 Plus Oxaliplatin	6	13	7
other	Constipation	Gastrointestinal disorders	TAS102 Plus Oxaliplatin	6	13	8
other	Cough	Respiratory, thoracic and mediastinal disorders	TAS102 Plus Oxaliplatin	1	13	1
other	Deep vein thrombosis	Vascular disorders	TAS102 Plus Oxaliplatin	1	13	1

1 to 10 of 62Source ClinicalTrials.gov

See all 62 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TAS102 Plus Oxaliplatin	1	13
Total, other adverse events	TAS102 Plus Oxaliplatin	13	13
Total, serious adverse events	TAS102 Plus Oxaliplatin	1	13

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/NCT04417699

GET https://conductscience.org/api/trials/v1/NCT04417699/events?page=2

API reference For AI assistants