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Radiation Therapy and Chemotherapy in Treating Patients with Stage I-IIIB Rectal Cancer

Trial Status: Active

This phase II trial studies how well patients with stage I-IIIB rectal cancer respond to a short course of radiation therapy followed by chemotherapy. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, fluorouracil, 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. A combination of radiation therapy and chemotherapy may prevent patients from needing surgery, could delay their need for surgery, or may mean that they need less drastic surgery and could potentially avoid a permanent ostomy (a surgically created connection between the intestine and the abdominal wall that allows for elimination of stool).

Inclusion Criteria

  • Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-2a, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including magnetic resonance imaging (MRI).
  • Tumor =< 12 cm from anal verge as determined by MRI or endoscopy.
  • Clinically detectable (magnetic resonance [MR], endoscopy, or digital rectal examination [DRE]) tumor present
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Absolute neutrophil count (ANC) > 1,500 cells/mm^3.
  • Hemoglobin (Hgb) > 8 g/dl.
  • Platelets > 100,000 cells/mm^3.
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.

Exclusion Criteria

  • Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer.
  • Prior oxaliplatin or capecitabine use for any malignancy.
  • Prior radiation therapy to the pelvis.
  • A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
  • Currently receiving any investigational agents.
  • A history of allergic reaction attributed to compounds of similar chemical or biologic composition to capecitabine, fluorouracil (5FU), oxaliplatin, or leucovorin.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.
  • Patients known history with human immunodeficiency virus (HIV) are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended. HIV testing for patients without a history of HIV is not a protocol requirement


Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE
Contact: Hyun Kim
Phone: 314-362-8502


University of Vermont Medical Center
Status: ACTIVE
Contact: Christopher J. Anker


I. To determine the clinical complete response (cCR) response rate of patients with stage I-IIIB (cT1-3, N0-2a, M0) rectal cancer being treated with sequential short course radiotherapy followed by multi-drug chemotherapy.


I. To obtain prospective patient reported outcomes from an organ preservation approach towards early stage rectal cancer.

II. To determine the 2 year progression free survival (PFS).

III. To determine the incidence of any grade >= 3 toxicity during treatment.

IV. To determine the incidence of post chemoradiotherapy grade >= 3 toxicity at 1 year.

V. To determine quality of anorectal function at 1 year using the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire.

VI. To determine the 1- and 2-year organ preservation rate.


I. To associate tumor microenvironment (including FAK expression) with cCR and other clinical outcomes.

II. To associate circulating tumor deoxyribonucleic acid (ctDNA) levels with cCR and other clinical outcomes.


Patients undergo 5 fractions of radiation therapy once daily (QD) over 5 days (Monday-Friday). Beginning 2-4 weeks, patients receive either FOLFOX regimen consisting of oxaliplatin intravenously (IV) over 2 hours, leucovorin IV over 2 hours, fluorouracil IV over 5-10 minutes followed by continuous infusion over 46 hours on day 1 or CAPOX regimen consisting of capecitabine orally (PO) twice daily (BID) on days 1-14 and oxaliplatin IV over 2 hours on day 1. Treatment with FOLFOX repeats every 14 days for up to 8 cycles and treatment with CAPOX repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months in year 1, every 3-4 months in year 2, and then every 4-6 months thereafter.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Siteman Cancer Center at Washington University

Principal Investigator
Hyun Kim

  • Primary ID 201904029
  • Secondary IDs NCI-2019-03209
  • ID NCT03904043