← Back to Search

Anti-metabolites

TAS-102 + Radiation for Rectal Cancer

Phase 1

Waitlist Available

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

Must not have

Women who are pregnant or breast-feeding

Participants who received prior pelvic radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at resection (up to 29 weeks)

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant or breast-feeding.

Select...

I have had radiation therapy to my pelvic area before.

Select...

I chose not to have standard surgery for my rectal cancer after initial treatment.

Select...

I cannot take medications by mouth.

Select...

I have a history of problems absorbing food or inflammatory bowel disease.

Select...

I have not had a heart attack, stroke, or severe chest pain in the last 6 months.

Select...

My cancer has spread to distant nodes or other areas, confirmed by scans.

Select...

I have severe nerve damage in my hands or feet.

Select...

My rectal cancer has come back.

Select...

I am not on FOLFOX or CAPOX chemotherapy.

Select...

I am not on any other experimental cancer treatments.

Select...

I am not taking any medications that weaken my immune system.

Select...

I cannot have a specific type of rectal surgery.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at resection (up to 29 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of dose limiting toxicity (DLT)s for TAS-102 at the maximum tolerated dose (MTD)

Secondary study objectives

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 study objectives

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 more

Side effects data

From 2021 Phase 2 trial • 28 Patients • NCT04072445

96%

Anemia

67%

Neutrophil count decreased

63%

Platelet count decreased

52%

Lymphocyte count decreased

48%

White blood cell decreased

33%

Fatigue

22%

Diarrhea

15%

Alkaline phosphatase increased

15%

Nausea

15%

Hypertension

11%

Biliary tract infection

11%

Dysgeusia

Blood bilirubin increased

Dyspnea

Alopecia

Ascites

Edema limbs

Non-cardiac chest pain

Paresthesia

Anorexia

Arthritis

Infusion related reaction

Spinal fracture

Gastroesophageal reflux disease

Mucositis oral

Abdominal pain

Infections and infestations - Oth spec

Intraoperative hemorrhage

Respiratory failure

Sepsis

Alanine aminotransferase increased

Febrile neutropenia

Aspartate aminotransferase increased

Arthralgia

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Trifluridine and Tipiracil, Irinotecan)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Trifluridine and Tipiracil Hydrochloride

2019

Completed Phase 2

~180

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160