Trial Outcomes & Findings for SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer (NCT NCT04417699)
NCT ID: NCT04417699
Last Updated: 2025-12-10
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Through study completion, an average of 6 months
Results posted on
2025-12-10
Participant Flow
Participant milestones
| Measure |
TAS102 Plus Oxaliplatin
Oxaliplatin 85mg/m2 IV over 2 hours and TAS-102 (35 mg/m2/dose) orally BID
TAS 102: Oral medication over Days 1-5
Oxaliplatin: Administered by intravenous infusion over 2 hours on day 1
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer
Baseline characteristics by cohort
| Measure |
TAS102 Plus Oxaliplatin
n=13 Participants
Oxaliplatin 85mg/m2 IV over 2 hours and TAS-102 (35 mg/m2/dose) orally BID
TAS 102: Oral medication over Days 1-5
Oxaliplatin: Administered by intravenous infusion over 2 hours on day 1
|
|---|---|
|
Age, Continuous
|
66 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=4 Participants
|
|
Baseline radiologic T stage
cT1
|
0 Participants
n=4 Participants
|
|
Baseline radiologic T stage
cT2
|
0 Participants
n=4 Participants
|
|
Baseline radiologic T stage
cT3a/b
|
12 Participants
n=4 Participants
|
|
Baseline radiologic T stage
cT3c/d
|
1 Participants
n=4 Participants
|
|
Baseline radiologic T stage
cT4
|
0 Participants
n=4 Participants
|
|
Baseline radiologic N stage
cN0
|
5 Participants
n=4 Participants
|
|
Baseline radiologic N stage
cN1
|
8 Participants
n=4 Participants
|
|
Baseline radiologic N stage
cN2
|
0 Participants
n=4 Participants
|
|
Baseline radiographic M stage
cM0
|
13 Participants
n=4 Participants
|
|
Baseline radiographic M stage
cM1
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 6 monthsDetermine 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
Outcome measures
| Measure |
TAS102 Plus Oxaliplatin
n=13 Participants
Oxaliplatin 85mg/m2 IV over 2 hours and TAS-102 (35 mg/m2/dose) orally BID
TAS 102: Oral medication over Days 1-5
Oxaliplatin: Administered by intravenous infusion over 2 hours on day 1
|
|---|---|
|
Neoadjuvant Response (NAR) Score
|
9.31 Calculated score
Standard Deviation 13.41
|
SECONDARY outcome
Timeframe: Through study completion, an average of 6 monthsThe secondary objective is to describe Incidence of Treatment-Emergent Adverse Events and surgery complications among treated subjects.
Outcome measures
| Measure |
TAS102 Plus Oxaliplatin
n=13 Participants
Oxaliplatin 85mg/m2 IV over 2 hours and TAS-102 (35 mg/m2/dose) orally BID
TAS 102: Oral medication over Days 1-5
Oxaliplatin: Administered by intravenous infusion over 2 hours on day 1
|
|---|---|
|
Safety and Tolerability
Number of patients who experienced Grade 3 or 4 adverse events
|
7 participants
|
|
Safety and Tolerability
Number of patients who experienced post-operative complications
|
0 participants
|
Adverse Events
TAS102 Plus Oxaliplatin
Serious events: 1 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
TAS102 Plus Oxaliplatin
n=13 participants at risk
Oxaliplatin 85mg/m2 IV over 2 hours and TAS-102 (35 mg/m2/dose) orally BID
TAS 102: Oral medication over Days 1-5
Oxaliplatin: Administered by intravenous infusion over 2 hours on day 1
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Rectal Perforation
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
Other adverse events
| Measure |
TAS102 Plus Oxaliplatin
n=13 participants at risk
Oxaliplatin 85mg/m2 IV over 2 hours and TAS-102 (35 mg/m2/dose) orally BID
TAS 102: Oral medication over Days 1-5
Oxaliplatin: Administered by intravenous infusion over 2 hours on day 1
|
|---|---|
|
Vascular disorders
Hypertenson
|
7.7%
1/13 • Number of events 2 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
General disorders
Injection site reaction (pain)
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Nervous system disorders
Intermittent headaches
|
15.4%
2/13 • Number of events 2 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Left flank pain
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Leg cramp
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Investigations
Lymphocyte count decreased
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
General disorders
Malaise
|
7.7%
1/13 • Number of events 2 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Nausea
|
61.5%
8/13 • Number of events 9 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Nervous system disorders
Neuropathy
|
61.5%
8/13 • Number of events 9 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.1%
3/13 • Number of events 5 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Investigations
Neutrophil count decreased
|
7.7%
1/13 • Number of events 3 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Nervous system disorders
Numbness
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Discharge on rectum
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Number of events 2 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Radiation cystitis
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Rectal incontinence
|
7.7%
1/13 • Number of events 2 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Musculoskeletal and connective tissue disorders
Shooting pain in foot
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Ileus
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Diverticulitis
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Vascular disorders
Tachycardia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.4%
2/13 • Number of events 2 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Vascular disorders
Thrombophlebitis
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Nervous system disorders
Tingling sensation in fingers
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Urgency with bowel movements
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Infections and infestations
Urinary Tract Infection
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Renal and urinary disorders
Urinary Urgency
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Infections and infestations
Viral Upper Respiratory Illness
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • Number of events 4 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Investigations
Weight loss
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Investigations
White blood cell decreased
|
15.4%
2/13 • Number of events 2 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Psychiatric disorders
Worsened Anxiety
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Worsening GERD
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Blood and lymphatic system disorders
Thromboytopenia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Investigations
Elevated liver fuction tests
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
General disorders
Fatigue
|
46.2%
6/13 • Number of events 7 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Fecal urgency
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Abdominal Cramping
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Abdominal Pain/Discomfort
|
30.8%
4/13 • Number of events 4 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Nervous system disorders
Anosmia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Investigations
Alanine aminotransferase increase
|
15.4%
2/13 • Number of events 4 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Investigations
Aspartate aminotransferase increase
|
15.4%
2/13 • Number of events 3 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Eye disorders
Blurred vision
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
General disorders
Cold sensitivity
|
46.2%
6/13 • Number of events 7 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Constipation
|
46.2%
6/13 • Number of events 8 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Vascular disorders
Deep vein thrombosis
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.4%
2/13 • Number of events 2 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
|
Gastrointestinal disorders
Diarrhea
|
69.2%
9/13 • Number of events 12 • Adverse events were collected from the time of consent through study completion, an average of 6 months.
|
Additional Information
Dr. Hagen Kennecke
OHSU Knight-Legacy Health Cancer Collaborative
Phone: 971-262-9600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place