Health Trials

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

ConditionsLocally Advanced Rectal CarcinomaRectal AdenocarcinomaStage II Rectal Cancer AJCC v8Stage IIA Rectal Cancer AJCC v8Stage IIB Rectal Cancer AJCC v8Stage IIC Rectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8Stage IIIA Rectal Cancer AJCC v8Stage IIIB Rectal Cancer AJCC v8Stage IIIC Rectal Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Capecitabine
  • Fluorouracil
  • Intensity-Modulated Radiation Therapy
  • Leucovorin
  • Oxaliplatin
  • Quality-of-Life Assessment
  • Surveillance
  • Total Mesorectal Excision

Treatment groups

25 Participants
are divided into 1 treatment group

Locations

1
UCLA / Jonsson Comprehensive Cancer Center90095, Los AngelesCalifornia, United States

Sponsors and collaborators

Jonsson Comprehensive Cancer Center

Lead sponsor

The Joseph Drown Foundation

Collaborator

Natera, Inc.

Collaborator

Source ClinicalTrials.gov