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Evaluating Trifluridine/Tipiracil Based Chemoradiation in Locally Advanced Rectal Cancer - The Phase I/II TARC Trial

NCT04177602 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-02-22

No results posted yet for this study

Summary

Seamless phase I/II trial with phase I part for determination of maximum tolerated dose (MTD) of Trifluridine/tipiracil, followed by a randomized phase II trial (randomization ratio 2:1) with an experimental arm with Trifluridine/tipiracil based chemoradiotherapy (CRT) and a standard - calibration arm (internal control) with capecitabine CRT flanked by translational research in patients with locally advanced rectal cancer

Conditions

  • Locally Advanced Rectal Cancer

Interventions

COMBINATION_PRODUCT

Trifluridine/tipiracil chemoradiation

Trifluridine/tipiracil based chemoradiation

COMBINATION_PRODUCT

Capecitabine based chemoradiation

Capecitabine based chemoradiation

Sponsors & Collaborators

  • Clinical Trial Center North (CTC North GmbH & Co. KG)

    collaborator OTHER

  • Servier Affaires Médicales

    collaborator INDUSTRY

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Alexander Stein · University Cancer Center Hamburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2022-09-02
Completion
2022-09-02

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04177602 on ClinicalTrials.gov