Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04703101

Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer

Led by Jonsson Comprehensive Cancer Center · Updated on 2026-03-30

25

Participants Needed

1

Research Sites

348 weeks

Total Duration

On this page

Sponsors

J

Jonsson Comprehensive Cancer Center

Lead Sponsor

T

The Joseph Drown Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase I trial investigates how well short-course radiation therapy followed by combination chemotherapy works in treating patients with stage II-III rectal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as leucovorin, fluorouracil, oxaliplatin, and capecitabine, 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. Giving short-course radiation therapy and combination chemotherapy may reduce the need for surgery and therefore improve quality of life.

CONDITIONS

Official Title

Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed rectal adenocarcinoma
  • Stage II (cT3, cN0) or stage III (cT1-3, cN1-3) tumor confirmed by MRI
  • No evidence of metastatic disease
  • Resectable primary tumor
  • Karnofsky performance status (KPS) of 70 or higher or ECOG score 0-2
  • Absolute neutrophil count greater than 1.5 cell/mm^3
  • Hemoglobin level greater than 8.0 gm/dL
  • Platelet count greater than 150,000/mm^3
  • Total bilirubin at or below 1.5 times the upper limit of normal
  • AST and ALT enzymes at or below three times the upper limit of normal
  • Negative pregnancy test for women of childbearing potential before starting radiation therapy
Not Eligible

You will not qualify if you...

  • Active treatment for a separate cancer
  • Distant metastatic disease shown by PET/CT or chest and abdomen CT within 6 weeks before radiation therapy
  • Previous radiation therapy to the pelvic area overlapping the study treatment fields
  • Pregnant or breastfeeding
  • Medical or psychological conditions preventing MRI examination

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095

Actively Recruiting

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Research Team

V

Vincent Basehart

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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