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

Recruiting now · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04703101

Run by

Jonsson Comprehensive Cancer Center

People needed

25

Starts

2021-02-11

Expected to finish

2027-10-15

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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