NCT02270606

Phase I Study of Neoadjuvant Radiotherapy With 5-Fluorouracil for Rectal Cancer

Phase I Study of Neoadjuvant Short Course Radiotherapy Concurrent With Infusional 5-Fluorouracil for the Treatment of Locally Advanced Rectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of fluorouracil when given together with radiation therapy followed by combination chemotherapy before and after surgery in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and oxaliplatin, 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 more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving additional combination chemotherapy after surgery may kill any remaining tumor cells. Giving radiation therapy and fluorouracil followed by combination chemotherapy before and after surgery may be a better treatment for rectal cancer.

Detailed description

OUTLINE: This is a dose-escalation study of fluorouracil. CHEMORADIATION: Patients undergo intensity-modulated radiation therapy (IMRT) once daily (QD) over 5 days for a total of 5 fractions and concurrently receive fluorouracil intravenously (IV) continuously over 96 hours. PREOPERATIVE CHEMOTHERAPY: Within 2 weeks of completing chemoradiation, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV as a push followed by IV continuously over 46 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Within 4-8 weeks of completing preoperative chemotherapy, patients undergo total mesorectal excision. POSTOPERATIVE CHEMOTHERAPY: Within 4-8 weeks after surgery, patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in preoperative chemotherapy. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year or until removal from the study or death, whichever occurs first.

Conditions

• Mucinous Adenocarcinoma of the Rectum
• Recurrent Rectal Cancer
• Signet Ring Adenocarcinoma of the Rectum
• Rectal Adenocarcinoma
• Stage IIA Rectal Cancer
• Stage IIB Rectal Cancer
• Stage IIC Rectal Cancer
• Stage IIIA Rectal Cancer
• Stage IIIB Rectal Cancer
• Stage IIIC Rectal Cancer

Interventions

Type	Name	Description
RADIATION	intensity-modulated radiation therapy	Undergo IMRT
DRUG	fluorouracil	Given IV
DRUG	oxaliplatin	Given IV
DRUG	leucovorin calcium	Given IV
PROCEDURE	therapeutic conventional surgery	Undergo total mesorectal excision

Timeline

• Start date: 2014-12-04
• Primary completion: 2018-05-14
• Completion: 2021-05-13
• First posted: 2014-10-21
• Last updated: 2021-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study