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RECRUITING
NCT04703101
PHASE1

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

Sponsor: Jonsson Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

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.

Official title: Organ Preservation for Patients With Locally Advanced Rectal Adenocarcinoma: Evaluating the Efficacy of Short Course Radiation Therapy Followed by FOLFOX or CapeOX

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2021-02-11

Completion Date

2027-10-15

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Capecitabine

Given IV

DRUG

Fluorouracil

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

DRUG

Leucovorin

Given IV

DRUG

Oxaliplatin

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

BEHAVIORAL

Surveillance

Undergo NOM

PROCEDURE

Total Mesorectal Excision

Undergo TME

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States