Related pages Drug Information Summaries 1 Approval Process for New Cancer Treatments 2 Access to Investigational Drugs 3

This page contains brief information about fluorouracil and a collection of links to more information about the use of this drug, related research results, and ongoing clinical trials.

US Brand Name(s):		Adrucil
		Efudex
		Fluoroplex
FDA Approved:		Yes

Fluorouracil is approved by the Food and Drug Administration (FDA) for palliative treatment of the following:

• Colorectal cancer.
• Breast cancer.
• Stomach cancer.
• Pancreatic cancer.

Fluorouracil is approved to be used with other drugs to treat:

• Metastatic colorectal cancer, including cancer that has recurred (come back) or gotten worse after earlier chemotherapy.
• Stage III colorectal cancer (given as adjuvant therapy).
• Locally advanced squamous cell carcinoma of the head and neck (SCCHN) that cannot be treated with surgery.
• Gastric adenocarcinoma.

Fluorouracil is also approved to be used by itself as a topical treatment for the following:

• Superficial basal cell carcinoma that cannot be treated with surgery.
• A skin condition called actinic keratosis.

Fluorouracil is also called "5-FU". In addition to the uses that have been approved by the FDA, fluorouracil is sometimes used alone or with other drugs to treat other types of cancer. Fluorouracil also continues to be studied in the treatment of many types of cancer.

Definition from the NCI Drug Dictionary ⁴ - Detailed scientific definition and other names for this drug.

Clinical Trial Results: 5-FU–Based Chemotherapy Cures Some Patients with Colon Cancer (02/03/2009) ⁵ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Chemotherapy Before Surgery May Increase Survival in Stomach Cancer (07/09/2007) ⁶ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Patients with Esophageal Cancer May Be Able to Avoid Surgery (04/16/2007) ⁷ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Chemotherapy Delays Recurrence of Liver Metastases from Colorectal Cancer (12/06/2006) ⁸ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Capecitabine an Alternative in Post-Surgery Treatment of Stage III Colon Cancer (07/27/2005) ⁹ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Docetaxel Combination Effective After Surgery for Node-Positive Breast Cancer (06/28/2005) ¹⁰ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Adding Docetaxel Improves Survival in Stomach Cancer (05/15/2005) ¹¹ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Docetaxel Before Radiation Extends Survival in Patients with Head and Neck Cancer (06/05/2004) ¹² - Important clinical trial results for this drug, background information, and how the trial was done.

MedlinePlus Information on Fluorouracil ¹³ - A lay language summary of important information about this drug that may include the following:

• warnings about this drug,
• what this drug is used for and how it is used,
• what you should tell your doctor before using this drug,
• what you should know about this drug before using it,
• other drugs that may interact with this drug, and
• possible side effects.

Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This NLM patient information sheet applies only to approved uses of the drug. However, much of the information may also apply to unapproved uses that are being studied.

MedlinePlus Information on Topical Fluorouracil ¹⁴ - A lay language summary of important information about this drug that may include the following:

• warnings about this drug,
• what this drug is used for and how it is used,
• what you should tell your doctor before using this drug,
• what you should know about this drug before using it,
• other drugs that may interact with this drug, and
• possible side effects.

Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This NLM patient information sheet applies only to approved uses of the drug. However, much of the information may also apply to unapproved uses that are being studied.

Clinical Trials for Fluorouracil ¹⁵ - Check for trials from NCI's PDQ Cancer Clinical Trials Registry now accepting patients.

Glossary Terms

A thick, scaly patch of skin that may become cancer. Also called senile keratosis and solar keratosis.

Cancer that begins in cells that line certain internal organs and that have gland-like (secretory) properties.

Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.

A type of skin cancer that arises from the basal cells, small round cells found in the lower part (or base) of the epidermis, the outer layer of the skin.

Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is a cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord. Also called malignancy.

Treatment with drugs that kill cancer cells.

Cancer that develops in the colon (the longest part of the large intestine) and/or the rectum (the last several inches of the large intestine before the anus).

An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled. The Food and Drug Administration also makes sure that drugs, medical devices, and equipment are safe and effective, and that blood for transfusions and transplant tissue are safe. Also called FDA.

Cancer that forms in tissues lining the stomach. Also called stomach cancer.

Cancer that arises in the head or neck region (in the nasal cavity, sinuses, lips, mouth, salivary glands, throat, or larynx [voice box]).

Cancer that has spread from where it started to nearby tissue or lymph nodes.

Having to do with metastasis, which is the spread of cancer from the primary site (place where it started) to other places in the body.

Treatment given to relieve the symptoms and reduce the suffering caused by cancer and other life-threatening diseases. Palliative cancer therapies are given together with other cancer treatments, from the time of diagnosis, through treatment, survivorship, recurrent or advanced disease, and at the end of life.

A disease in which malignant (cancer) cells are found in the tissues of the pancreas. Also called exocrine cancer.

Cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body. Also called recurrence.

Cancer that begins in squamous cells, which are thin, flat cells that look like fish scales. Squamous cells are found in the tissue that forms the surface of the skin, the lining of the hollow organs of the body, and the passages of the respiratory and digestive tracts. Also called epidermoid carcinoma.

Tumor cells have spread to organs and lymph nodes near the colon/rectum. Also called Dukes C colorectal cancer.

Cancer that forms in tissues lining the stomach. Also called gastric cancer.

Affecting cells on the surface. Not invasive.

A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.

On the surface of the body.