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Anti-metabolites
TAS-102 + Radiation for Rectal Cancer
Phase 1
Recruiting
Led By Charles D Lopez, MD, PhD
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must, as part of their planned treatment per institutional guidelines, be: Scheduled to receive preoperative FOLFOX or CAPOX chemotherapy, which requires a central venous access device for administration
Male participants must agree to use an effective method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at resection (up to 29 weeks)
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of TAS-102 when given with radiation therapy to treat patients with stage II-III rectal cancer.
Who is the study for?
This trial is for adults with stage II-III rectal cancer that hasn't spread, can be surgically removed, and who haven't had prior treatments. Participants must have good organ function, no serious infections or recent heart issues, and not be pregnant or breastfeeding. They should agree to use contraception and be able to take oral meds.Check my eligibility
What is being tested?
The study tests the safety and best dose of TAS-102 chemotherapy combined with radiation therapy (either intensity-modulated or 3-dimensional conformal) in patients with resectable rectal cancer. The goal is to find out how well this combo works before surgery.See study design
What are the potential side effects?
Possible side effects include reactions related to chemotherapy such as nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver enzyme changes, and typical radiation therapy side effects like skin irritation at the treatment site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for specific chemotherapy that needs a central line.
Select...
I agree to use effective birth control during and for 6 months after the study.
Select...
My condition is a type of rectal cancer called adenocarcinoma.
Select...
My cancer has not spread to distant parts of my body.
Select...
My cancer is at stage II or III according to MRI results.
Select...
I am not pregnant and will use reliable birth control during the study.
Select...
My rectal tumor can be surgically removed.
Select...
I am fully active or can carry out light work.
Select...
I agree to use effective birth control during and for 6 months after the study.
Select...
My kidney function, measured by creatinine levels, is normal or nearly normal.
Select...
I am eligible for a specific rectal cancer surgery according to hospital rules.
Select...
I have not had radiation therapy to my pelvic area.
Select...
I have not had chemotherapy or surgery for rectal cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at resection (up to 29 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at resection (up to 29 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of dose limiting toxicity (DLT)s for TAS-102 at the maximum tolerated dose (MTD)
Secondary outcome measures
Incidence of adverse events (AEs) (all grade) for TAS-102 concurrent with radiation therapy (RT)
Incidence of grade 3 or higher treatment emergent adverse events (TEAEs) during FOLFOX or CAPOX treatment
Other outcome measures
Rate of CR by MRI after CRT and FOLFOX or CAPOX
Rate of CR by endoscopic exam after CRT
Rate of CR by endoscopic exam after CRT and FOLFOX or CAPOX
+4 moreSide effects data
From 2021 Phase 2 trial • 28 Patients • NCT0407244596%
Anemia
67%
Neutrophil count decreased
63%
Platelet count decreased
52%
Lymphocyte count decreased
48%
White blood cell decreased
33%
Fatigue
22%
Diarrhea
15%
Nausea
15%
Alkaline phosphatase increased
15%
Hypertension
11%
Dysgeusia
11%
Biliary tract infection
7%
Dyspnea
7%
Ascites
7%
Edema limbs
7%
Blood bilirubin increased
7%
Alopecia
4%
Febrile neutropenia
4%
Intraoperative hemorrhage
4%
Respiratory failure
4%
Anorexia
4%
Non-cardiac chest pain
4%
Arthritis
4%
Gastroesophageal reflux disease
4%
Abdominal pain
4%
Arthralgia
4%
Sepsis
4%
Mucositis oral
4%
Spinal fracture
4%
Paresthesia
4%
Infections and infestations - Oth spec
4%
Aspartate aminotransferase increased
4%
Infusion related reaction
4%
Alanine aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Trifluridine and Tipiracil, Irinotecan)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (TAS-102, IMRT, 3D-CRT)Experimental Treatment3 Interventions
Patients receive TAS-102 PO BID Monday-Friday on weeks 1, 3, and 5. Patients also undergo IMRT or 3D-CRT 5 days per week on weeks 1-5. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care FOLFOX or CAPOX.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Trifluridine and Tipiracil Hydrochloride
2019
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,708 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
7,385,794 Total Patients Enrolled
Taiho Pharmaceutical Co., Ltd.Industry Sponsor
63 Previous Clinical Trials
16,280 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breast-feeding.I have had blood clots or am on stable blood thinner medication.I have not had any cancer except for certain skin cancers or cervical cancer in situ in the last 5 years.I am scheduled for specific chemotherapy that needs a central line.You have a history of allergic reactions to drugs similar to TAS-102 or other drugs used in this study.I agree to use effective birth control during and for 6 months after the study.My condition is a type of rectal cancer called adenocarcinoma.My cancer has not spread to distant parts of my body.I received initial chemotherapy before chemo-radiation for rectal cancer.My cancer is at stage II or III according to MRI results.I am not pregnant and will use reliable birth control during the study.I have had radiation therapy to my pelvic area before.I chose not to have standard surgery for my rectal cancer after initial treatment.My rectal tumor can be surgically removed.You have had a fever in the past week before joining the study.I cannot take medications by mouth.I am fully active or can carry out light work.You have other medical or mental health conditions that, according to the doctor's opinion, would make you unsuitable for this study.I have a history of problems absorbing food or inflammatory bowel disease.I do not have any infections needing strong antibiotics.I have not had a heart attack, stroke, or severe chest pain in the last 6 months.My cancer has spread to distant nodes or other areas, confirmed by scans.I have severe nerve damage in my hands or feet.I agree to use effective birth control during and for 6 months after the study.My kidney function, measured by creatinine levels, is normal or nearly normal.My rectal cancer has come back.I am not on FOLFOX or CAPOX chemotherapy.I am not on any other experimental cancer treatments.I am eligible for a specific rectal cancer surgery according to hospital rules.I am not taking any medications that weaken my immune system.My rectal cancer cannot be removed with surgery and may have spread to nearby organs.I cannot have a specific type of rectal surgery.I have not had radiation therapy to my pelvic area.I have not had chemotherapy or surgery for rectal cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (TAS-102, IMRT, 3D-CRT)
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.
Are there any potential side-effects of Trifluridine and Tipiracil Hydrochloride use?
"Due to the lack of evidence for both safety and efficacy, Trifluridine and Tipiracil Hydrochloride receive a score of 1 on our team's assessment scale."
Answered by AI
Are there any historical trials that have explored the efficacy of Trifluridine and Tipiracil Hydrochloride combined?
"Currently, 43 studies are running for Trifluridine and Tipiracil Hydrochloride with 4 trials at an advanced stage of development. Primarily situated in Lakewood, New jersey, these clinical investigations encompass a total of 527 medical sites."
Answered by AI
How many individuals have been recruited for participation in this medical trial?
"That is correct. According to information shared on clinicaltrials.gov, this clinical trial that debuted December 11th 2019 is presently trying to find participants. 18 individuals need to be enrolled from 1 medical site."
Answered by AI
What conditions do Trifluridine and Tipiracil Hydrochloride treat most effectively?
"Trifluridine and Tipiracil Hydrochloride have proven to be a successful treatment for vaccinia infection on the cornea or conjunctiva. Other conditions this medication has effectively treated include those previously managed with oxaliplatin chemotherapy, anti-vegf agents, and blepharitis."
Answered by AI
Is this clinical trial novel in its approach?
"To date, 43 live clinical trials have been conducted around the world in 28 different countries utilizing Trifluridine and Tipiracil Hydrochloride. The initial study was sponsored by Taiho Oncology Inc. In 2017 with 56 participants; since then an additional 52 tests have been completed."
Answered by AI
Is there still an opportunity to become involved in this research endeavor?
"Clinicaltrials.gov currently reports that this trial is actively soliciting participants; the initial post was made on December 11th 2019 and subsequently updated on May 6th 2022."
Answered by AI
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