RecruitingPhase 1NCT04703101

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

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

Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

25 participants

Start Date

Feb 11, 2021

Study Type

INTERVENTIONAL

Conditions

Rectal Adenocarcinoma Locally Advanced Rectal Carcinoma Stage II Rectal Cancer AJCC v8 Stage III Rectal Cancer AJCC v8 Stage IIA Rectal Cancer AJCC v8 Stage IIB Rectal Cancer AJCC v8 Stage IIC Rectal Cancer AJCC v8 Stage IIIA Rectal Cancer AJCC v8 Stage IIIB Rectal Cancer AJCC v8 Stage IIIC Rectal Cancer AJCC v8

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment approach for stage II and III rectal cancer that combines short-course radiation therapy with a multi-drug chemotherapy regimen before surgery. The goal is to shrink the tumor as much as possible before removing it. **You may be eligible if...** - You have been diagnosed with rectal cancer (adenocarcinoma) confirmed by biopsy - Your cancer is stage II (T3, N0) or stage III (T1-3, N1-3), confirmed by MRI - Your cancer can be surgically removed - You have not received prior radiation or chemotherapy for this cancer - Your general health and blood/organ function are adequate (Karnofsky ≥70 or ECOG 0-2) **You may NOT be eligible if...** - Your cancer has spread to other organs (metastatic) - You have had prior pelvic radiation therapy - You are pregnant - You have severe heart, kidney, or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

Given IV

DRUGFluorouracil

Given IV

RADIATIONIntensity-Modulated Radiation Therapy

Undergo IMRT

DRUGLeucovorin

Given IV

DRUGOxaliplatin

Given IV

OTHERQuality-of-Life Assessment

Ancillary studies

BEHAVIORALSurveillance

Undergo NOM

PROCEDURETotal Mesorectal Excision

Undergo TME

Locations(1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

View Full Details on ClinicalTrials.gov

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NCT04703101

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