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

{ "Short Course Radiation and Chemotherapy for Stage II-III Rectal Cancer", "This study is looking at how well a combination of short-course radiation therapy and chemotherapy works for people with stage II or III rectal cancer. The radiation therapy, called Intensity-Modulated Radiation Therapy (IMRT), uses high-energy X-rays to target cancer cells. The chemotherapy involves several drugs: Capecitabine, Fluorouracil, Leucovorin, and Oxaliplatin, which work in different ways to stop cancer growth. The goal is to see if this treatment can lead to a complete clinical response, potentially reducing the need for surgery and improving quality of life. You may be able to join if you have confirmed stage II or III rectal adenocarcinoma that hasn't spread, are at least 18 years old, and meet certain health criteria. The study aims to enroll 25 participants.", "design": "This is an interventional study, meaning participants will receive a specific treatment. It is a single-arm study with a planned enrollment of 25 participants.", "commitments": "Participants will undergo Intensity-Modulated Radiation Therapy (IMRT) daily for 5 consecutive days, followed by 16 weeks of combination chemotherapy. The primary outcome, complete clinical response, will be measured for up to 5 years.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed to assess complete clinical response for up to 5 years. Other follow-up includes 1-year local recurrence-free survival and 1-year progression-free survival.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT04703101

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Jonsson Comprehensive Cancer Center
~25 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:CapecitabineFluorouracilIntensity-Modulated Radiation TherapyLeucovorinOxaliplatinQuality-of-Life Assessment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete clinical response rate
Measured over Up to 5 years
Locally Advanced Rectal Carcinoma
Rectal Adenocarcinoma
Stage II Rectal Cancer AJCC v8
Stage IIA Rectal Cancer AJCC v8
Stage IIB Rectal Cancer AJCC v8
Stage IIC Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
Stage IIIA Rectal Cancer AJCC v8
Stage IIIB Rectal Cancer AJCC v8
Stage IIIC Rectal Cancer AJCC v8
1 sites across 1 states
California1
  • Ann Raldow · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

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Eligibility criteria

Inclusion

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

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
  • Complete clinical response rateUp 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.