NCT04703101 · Jonsson Comprehensive Cancer Center
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
What this study 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.
View original scientific description
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.
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
Primary outcome measures
Complete clinical response rate
Time frame: Up to 5 years
Kaplan-Meier analysis will be carried out and used to estimate for the entire cohort as well the non-operational management (NOM) and total mesorectal excision (TME) cohorts separately.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
Collaborators
The Joseph Drown Foundation, Natera, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations