Georgia's Online Cancer Information Center

Find A Clinical Trial

Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiotherapy With Versus Without Adjuvant Chemotherapy in Patients With High-Risk Early-Stage Cervical Carcinoma After Radical Hysterectomy

Status
Active
Cancer Type
Cervical Cancer
Trial Phase
Phase III
Eligibility
18 and over, Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCT ID
NCT00980954
Protocol IDs
RTOG-0724 (primary)
RTOG 0724
Study Sponsor
Radiation Therapy Oncology Group

Summary

Rationale

DrugsAny substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic. used in chemotherapy(KEE-moh-THAYR-uh-pee)

Treatment with drugs that kill cancer cells.
, such as cisplatin(sis-PLA-tin)

A drug used to treat many types of cancer. Cisplatin contains the metal platinum. It kills cancer cells by damaging their DNA and stopping them from dividing. Cisplatin is a type of alkylating agent.
, paclitaxel(PA-klih-TAK-sil)

A drug used to treat breast cancer, ovarian cancer, and AIDS-related Kaposi sarcoma. It is also used together with another drug to treat non-small cell lung cancer. Paclitaxel is also being studied in the treatment of other types of cancer. It blocks cell growth by stopping cell division and may kill cancer cells. It is a type of antimitotic agent. Also called Taxol.
, and carboplatin(KAR-boh-pla-tin)

A drug that is used to treat advanced ovarian cancer that has never been treated or symptoms of ovarian cancer that has come back after treatment with other anticancer drugs. It is also used with other drugs to treat advanced, metastatic, or recurrent non-small cell lung cancer and is being studied in the treatment of other types of cancer. Carboplatin is a form of the anticancer drug cisplatin and causes fewer side effects in patients. It attaches to DNA in cells and may kill cancer cells. It is a type of platinum compound. Also called Paraplatin.
, work in different ways to stop the growth of tumor(TOO-mer)

An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Tumors may be benign (not cancer), or malignant (cancer). Also called neoplasm.
cells(sel)

The individual unit that makes up the tissues of the body. All living things are made up of one or more cells.
, either by killing the cells or by stopping them from dividing. Radiation therapy(RAY-dee-AY-shun THAYR-uh-pee)

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.
uses high-energy x-rays(EX-ray)

A type of high-energy radiation. In low doses, x-rays are used to diagnose diseases by making pictures of the inside of the body. In high doses, x-rays are used to treat cancer.
to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer(SER-vih-kul KAN-ser)

Cancer that forms in tissues of the cervix (the organ connecting the uterus and vagina). It is usually a slow-growing cancer that may not have symptoms but can be found with regular Pap tests (a procedure in which cells are scraped from the cervix and looked at under a microscope). Cervical cancer is almost always caused by human papillomavirus (HPV) infection.
.

Purpose

This randomized(RAN-duh-mized KLIH-nih-kul TRY-ul)

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
phase III trialA study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people. is studying chemotherapy and pelvicHaving to do with the pelvis (the lower part of the abdomen located between the hip bones). radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk(hy-risk KAN-ser)

Cancer that is likely to recur (come back), or spread.
early-stage(ER-lee stayj KAN-ser)

A term used to describe cancer that is early in its growth, and may not have spread to other parts of the body. What is called early stage may differ between cancer types.
cervical cancer after radical hysterectomy(RA-dih-kul HIS-teh-REK-toh-mee)

Surgery to remove the uterus, cervix, and part of the vagina. The ovaries, fallopian tubes, and nearby lymph nodes may also be removed.
.

Objectives

Primary

  1. To determine if administering adjuvant systemic chemotherapy after chemoradiotherapy will improve disease-free survival compared to chemoradiotherapy alone in patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after radical hysterectomy.

Secondary

  1. To evaluate adverse events.
  2. To evaluate overall survival.
  3. To evaluate quality of life.
  4. To evaluate chemotherapy-induced neuropathy.
  5. To perform a post-hoc dose-volume evaluation between patients treated with standard radiotherapy and patients treated with intensity-modulated radiotherapy with respect to toxicity and local control.
  6. To collect fixed tissue samples to identify tumor molecular signatures that may be associated with patient outcomes, such as adverse events, disease-free survival, and overall survival.
  7. To collect blood samples to identify secreted factors from serum and plasma that may be associated with adverse events or outcome and to identify SNPs in genes from buffy coat that may be associated with a genetic predisposition to tumor formation itself or a response to cytotoxic therapy.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a state-supported nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education to improve cancer care for Georgians in rural, urban, and suburban communities across the state.