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NCT03297710 · ClinicalTrials.gov registry record · Phase 1

TAS-102 and Radiation Therapy in Treating Patients With Rectal Cancer That Is Locally Recurrent, Metastatic, or Cannot Be Removed by Surgery

A Phase 1 study, sponsored by Mayo Clinic.

Completed
Registry status
Phase 1
Development phase
7
Enrollment target

NCT03297710: Completed Phase 1 study, sponsored by Mayo Clinic.

NCT03297710 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT03297710, a Phase 1 study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 1
Development phase
7 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) when given together with radiation therapy in treating patients with rectal cancer that has come back, spread to other places in the body, or cannot be removed by surgery. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving TAS-102 with radiation therapy may kill more tumor cells.

Primary Outcome

Defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients.

Interventions

  • OTHER Quality-of-Life Assessment
  • RADIATION Radiation Therapy
  • DRUG Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2017-12-11
Est. Completion 2021-04-30
Phase Phase 1
Mayo Clinic

2,844 total trials

What the finished NCT03297710 record still lists

NCT03297710 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.

NCT03297710 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03297710 about?

NCT03297710 is a clinical study titled "TAS-102 and Radiation Therapy in Treating Patients With Rectal Cancer That Is Locally Recurrent, Metastatic, or Cannot Be Removed by Surgery". This phase I trial studies the side effects and best dose of trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) when given together with radiation therapy in treating patients with rectal cancer that has come back, spread to other places in the body, or cannot be removed by sur...

What is the current status of trial NCT03297710?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2017-12-11. Estimated completion is 2021-04-30.

What interventions are being tested in trial NCT03297710?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Radiation Therapy (RADIATION), Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102 (DRUG).

Who is sponsoring clinical trial NCT03297710?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03297710's enrollment target sits among peer trials

7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03297710, the US trial registry maintained by the National Library of Medicine. NCT03297710 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.