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Pilot Trial of KD018 With Neo-Adjuvant Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Rectal Cancer

NCT02178644 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-10-08

No results posted yet for this study

Summary

This pilot study focuses on KD018 and will investigate the effect of this agent on reducing the Gastrointestinal (GI) toxicity associated with combined modality therapy of locally-advanced rectal cancer.

Conditions

Interventions

DRUG

Chemo with concomitant Capecitabine and KD018

Patients will receive a course of chemo-radiation with concomitant Capecitabine and KD018, and to compare this to the toxicity seen in patients treated with Capecitabine and radiation therapy alone, in patients with T3-T4 and N0-N2, M0 rectal cancer.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Susan A Higgins, M.D., M.S. · Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2019-09-20
Completion
2019-09-20

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02178644 on ClinicalTrials.gov