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Short-course Radiation Followed by mFOLFOX-6 Plus COMPOUND 2055269 for Locally-advanced Rectal Adenocarcinoma

NCT03503630 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-01-31

No results posted yet for this study

Summary

The purpose of this study is to show that the addition of COMPOUND 2055269, an immunotherapeutic drug, to Folfox chemotherapy will improve the pathologic complete response rate in patients with locally advanced rectal cancer.

Conditions

  • Locally Advanced Rectal Cancer

Interventions

DRUG

COMPOUND 2055269

COMPOUND 2055269 to be given every 2 weeks with chemotherapy for 6 cycles

RADIATION

Radiation Therapy

Radiotherapy 25 Gy to be given on Days 1-5

DRUG

mFOLFOX

Given every 2 weeks for 6 cycles

PROCEDURE

Total Mesorectal Excision

Surgery to be done 2-3 weeks after last cycle of chemotherapy and COMPOUND 2055269

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • Phoenix Clinical Research

    collaborator OTHER

  • Ali Shamseddine

    lead OTHER

Principal Investigators

  • Ali I Shamseddine, M.D. · American University of Beirut Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-20
Primary Completion
2021-03-15
Completion
2024-07-02

Countries

  • Jordan
  • Lebanon

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 NCT03503630 on ClinicalTrials.gov