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

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.

Conditions

• 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

Interventions

DRUG

Capecitabine

Given IV

DRUG

Fluorouracil

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

DRUG

Leucovorin

Given IV

DRUG

Oxaliplatin

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

BEHAVIORAL

Surveillance

Undergo NOM

PROCEDURE

Total Mesorectal Excision

Undergo TME

Sponsors & Collaborators

• The Joseph Drown Foundation

  collaborator UNKNOWN

• Natera, Inc.

  collaborator INDUSTRY

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Ann Raldow · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-11

Primary Completion

2026-10-01

Completion

2027-10-15

FDA Drug

Yes

Countries

• United States

Study Locations