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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

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* Histologically confirmed rectal adenocarcinoma
* Patients must have stage II (cT3, cN0) or stage III (cT1-3, cN1-3) tumor as staged by MRI
* No evidence of metastatic disease
* Resectable primary lesion
* Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
* Absolute neutrophil count (ANC) \> 1.5 cell/mm\^3
* Hemoglobin (Hgb) \> 8.0 gm/dL
* Platelets (PLT) \> 150,000/mm\^3
* Total bilirubin \< or equal to 1.5 x upper limit of normal
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< or equal to three times upper limit of normal
* If a woman is of childbearing potential, a negative serum pregnancy test must be documented prior to initiation of radiation therapy

Exclusion Criteria:

* Active treatment of a separate malignancy
* Distant metastatic disease as assessed by staging positron emission tomography (PET)/computed tomography (CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Pregnant and/or breastfeeding
* Medical/psychological contraindication to MRI

About the study

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.

What is being tested

• Capecitabine (drug)
• Fluorouracil (drug)
• Intensity-Modulated Radiation Therapy (radiation)
• Leucovorin (drug)
• Oxaliplatin (drug)
• Quality-of-Life Assessment (other)

Sponsor: Jonsson Comprehensive Cancer Center · Participants: 25 · Started: Feb 11, 2021

Contact the study team

• Vincent Basehart · Phone: 310 267-8954

Official record on ClinicalTrials.gov — NCT04703101

Locations in the U.S.

Conditions

• Rectal Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.