Overview

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

Status:
Completed
Trial end date:
2021-05-13
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Virginia Commonwealth University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Calcium
Calcium, Dietary
Fluorouracil
Formyltetrahydrofolates
Leucovorin
Levoleucovorin
Oxaliplatin
Tetrahydrofolates