RecruitingPhase 1NCT04703101

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

Organ Preservation for Patients With Locally Advanced Rectal Adenocarcinoma: Evaluating the Efficacy of Short Course Radiation Therapy Followed by FOLFOX or CapeOX

Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

25 participants

Start Date

Feb 11, 2021

Study Type

INTERVENTIONAL

Conditions

Rectal Adenocarcinoma Locally Advanced Rectal Carcinoma Stage II Rectal Cancer AJCC v8 Stage III Rectal Cancer AJCC v8 Stage IIA Rectal Cancer AJCC v8 Stage IIB Rectal Cancer AJCC v8 Stage IIC Rectal Cancer AJCC v8 Stage IIIA Rectal Cancer AJCC v8 Stage IIIB Rectal Cancer AJCC v8 Stage IIIC Rectal Cancer AJCC v8

Summary

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

Min Age: 18 Years

Inclusion Criteria11

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 Criteria5

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