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Alkylating agents
Short Course Radiation + TASOX for Rectal Cancer (SHORT Trial)
Phase 2
Waitlist Available
Led By Houng Pham, MD
Research Sponsored by Benaroya Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical Stage: T1/N1, T2/N1, T3/N1, T3c/dN0
Absence of metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights
SHORT Trial Summary
This trial shows that TASOX can be safely and effectively given after a short course of radiation, allowing for successful R0 surgery and local control in patients with stage II/III rectal cancer.
Who is the study for?
This trial is for adults over 18 with stage II/III rectal cancer who are candidates for sphincter-sparing surgery and have no metastatic disease. They must not have had chemotherapy in the last 5 years or prior pelvic radiation, and should be able to use contraception if of childbearing potential.Check my eligibility
What is being tested?
The study tests TASOX (TAS102 plus Oxaliplatin) chemotherapy following short course radiation therapy to see if it can safely shrink tumors before surgery, allowing for complete removal without affecting the anal sphincter in rectal cancer patients.See study design
What are the potential side effects?
Possible side effects include reactions related to TAS102 and Oxaliplatin such as fatigue, digestive issues like nausea and diarrhea, nerve damage that may cause tingling or numbness in hands and feet, blood cell count changes leading to increased infection risk.
SHORT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is in an early to mid-stage but has spread to nearby lymph nodes.
Select...
My cancer has not spread to other parts of my body.
Select...
My scans show 4 or more lymph nodes larger than 8mm.
Select...
My rectal cancer has spread to the lymph nodes in my groin area.
Select...
My scans show 1-3 lymph nodes larger than 8 mm.
Select...
I have been newly diagnosed with rectal cancer.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My tumor can be removed with surgery aimed at curing me without affecting my sphincter.
SHORT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Achieve a reduction by at least 5.8 in Neoadjuvant Response (NAR) score compared to historic controls with NAR of 14.59
Secondary outcome measures
Safety and Tolerability
Side effects data
From 2016 Phase 4 trial • 128 Patients • NCT0158899068%
Nausea
63%
Neuropathy peripheral
63%
Fatigue
55%
Diarrhoea
40%
Constipation
31%
Abdominal pain
30%
Palmar-plantar erythrodysaesthesia syndrome
28%
Vomiting
25%
Neutropenia
24%
Mucosal inflammation
23%
Epistaxis
22%
Decreased appetite
20%
Paraesthesia
20%
Insomnia
20%
Alopecia
20%
Gastrooesophageal reflux disease
19%
Headache
18%
Hypertension
17%
Stomatitis
17%
Back pain
16%
Urinary tract infection
16%
Rash
16%
Dysgeusia
14%
Upper respiratory tract infection
14%
Pain in extremity
13%
Mouth ulceration
13%
Thrombocytopenia
13%
Arthralgia
12%
Anaemia
12%
Dysaesthesia
11%
Weight decreased
11%
Oedema peripheral
11%
Musculoskeletal pain
10%
Dyspnoea
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Pulmonary embolism
10%
Dizziness
9%
Dysphonia
9%
Depression
9%
Pyrexia
8%
Anxiety
8%
Dry skin
8%
Fall
8%
Proteinuria
7%
Lethargy
7%
Abdominal distension
7%
Rectal haemorrhage
7%
Toothache
7%
Neck pain
6%
Dehydration
6%
Oropharyngeal pain
6%
Rhinorrhoea
6%
Non-cardiac chest pain
5%
Intestinal obstruction
5%
Hypoalbuminaemia
5%
Nail disorder
5%
Hypotension
5%
Haemorrhoids
5%
Oral candidiasis
5%
Oral herpes
5%
Hypokalaemia
5%
Muscle spasms
5%
Sepsis
2%
Gastroenteritis
2%
Bronchitis
2%
Lower respiratory tract infection
2%
Pneumonia
2%
Small intestinal obstruction
2%
Anal abscess
2%
Flank pain
2%
Renal failure acute
2%
Confusional state
2%
Febrile neutropenia
2%
Angina pectoris
2%
Enterovesical fistula
1%
Intestinal perforation
1%
Gastrointestinal perforation
1%
Infected dermal cyst
1%
Infective exacerbation of chronic obstructive airways disease
1%
Colonic obstruction
1%
Inguinal hernia
1%
Muscle abscess
1%
Clostridium difficile colitis
1%
Ileus
1%
Anal fissure
1%
Gastroenteritis viral
1%
Colitis
1%
Lobar pneumonia
1%
Pharyngitis
1%
Pneumonia streptococcal
1%
Large intestine perforation
1%
Melaena
1%
Neutropenic colitis
1%
Cholecystitis acute
1%
Urosepsis
1%
Wound infection
1%
Infusion related reaction
1%
Procedural site reaction
1%
Cerebrovascular accident
1%
Hemiparesis
1%
Syncope
1%
Rectal perforation
1%
Catheter site pain
1%
Extravasation
1%
Abscess limb
1%
Radius fracture
1%
Hypomagnesaemia
1%
Hypophagia
1%
Haematuria
1%
Hydronephrosis
1%
Urinary incontinence
1%
Pleural effusion
1%
Pleuritic pain
1%
Musculoskeletal chest pain
1%
Procedural pain
1%
Laceration
1%
Gastrointestinal haemorrhage
1%
Large intestinal obstruction
1%
Transient ischaemic attack
1%
Acute psychosis
1%
Pneumonia aspiration
1%
Jugular vein thrombosis
1%
Orthostatic hypotension
1%
Thrombophlebitis superficial
1%
Device related infection
1%
Ear infection
1%
Enterocolitis infectious
1%
Eyelid infection
1%
Gangrene
1%
Pilonidal cyst
1%
Gastritis
1%
Visual impairment
1%
Dysphagia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab: Phase A and Phase B
SHORT Trial Design
1Treatment groups
Experimental Treatment
Group I: TAS102 plus OxaliplatinExperimental Treatment2 Interventions
Oxaliplatin 85mg/m2 IV over 2 hours and TAS-102 (35 mg/m2/dose) orally BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
2011
Completed Phase 4
~2560
TAS 102
2017
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
Benaroya Research InstituteLead Sponsor
45 Previous Clinical Trials
11,304 Total Patients Enrolled
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,522 Total Patients Enrolled
Taiho OncologyUNKNOWN
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgeon has recommended an APR surgery for me.My tumor is more than 1mm away from the mesorectal fascia.My breast cancer is in an early to mid-stage but has spread to nearby lymph nodes.My cancer has not spread to other parts of my body.My cancer is large or has spread to nearby tissues.I have had radiation therapy to my pelvic area before.My scans show 4 or more lymph nodes larger than 8mm.My tumor is not causing bowel blockage nor have I had a temporary ostomy.I haven't had chemotherapy in the last 5 years, but hormone therapy is okay.My scans show the tumor is too close to or invading the protective layer around the rectum, making complete surgical removal unlikely.My surgeon believes I can have surgery to remove my cancer without affecting my sphincter.My rectal cancer has spread to the lymph nodes in my groin area.My scans show 1-3 lymph nodes larger than 8 mm.I have been newly diagnosed with rectal cancer.I am 18 years old or older.I have at least four lymph nodes larger than 8 mm.I can take care of myself and am up and about more than half of my waking hours.My tumor can be removed with surgery aimed at curing me without affecting my sphincter.
Research Study Groups:
This trial has the following groups:- Group 1: TAS102 plus Oxaliplatin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Oxaliplatin for public use?
"Oxaliplatin was determined to be a 2 on the safety scale because this is a Phase 2 trial, indicating that there are some records of its safety but no verifiable evidence for efficacy."
Answered by AI
Has Oxaliplatin been investigated for any other medical applications?
"Currently, 339 clinical trials are investigating the use of Oxaliplatin with 122 in Phase 3. While many studies for this medication take place in Melbourne, Victoria there is a total of 13673 trial locations around the globe."
Answered by AI
What is the aggregate sum of participants involved in this experiment?
"To move forward with this trial, 27 qualified patients will need to be enrolled. These individuals may come from Virginia Mason Medical Center in Orange, California or the University of California Irvine in Portland Oregon."
Answered by AI
Are there still vacancies for volunteers in this clinical trial?
"Affirmative. Clinicaltrials.gov states that this medical trial, which was initially posted on July 5th 2022 and amended most recently on the 8th of July, is actively seeking participants. The study requires 27 patients to be recruited from 5 different research locations."
Answered by AI
How extensively is this clinical investigation being conducted in the city?
"At present, this research is being conducted at 5 medical centres. These locations include Orange, Portland and New york in addition to two other cities. To minimize travel burdens, it would be best for prospective participants to select the closest trial site available."
Answered by AI
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