MedTrace Logo

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

NCT02270606 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-07-20

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Emma C Fields, MD · Massey 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
2014-12-04
Primary Completion
2018-05-14
Completion
2021-05-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02270606 on ClinicalTrials.gov