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Phase II Randomized Study of Pelvic Radiotherapy With Versus Without Cisplatin in Patients With Recurrent Endometrial Cancer

Status
Active
Cancer Type
Endometrial Cancer
Trial Phase
Phase II
Eligibility
Not specified, Female
Study Type
Treatment
NCD ID
NCT00492778
Protocol IDs
GOG-0238 (primary)
GOG-0238
Study Sponsor
Gynecologic Oncology Group

Summary

Rationale

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.
and other types of radiation(RAY-dee-AY-shun)

Energy released in the form of particle or electromagnetic waves. Common sources of radiation include radon gas, cosmic rays from outer space, medical x-rays, and energy given off by a radioisotope (unstable form of a chemical element that releases radiation as it breaks down and becomes more stable).
to kill 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.
. 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.
, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer(EN-doh-MEE-tree-ul KAN-ser)

Cancer that forms in the tissue lining the uterus (the small, hollow, pear-shaped organ in a woman's pelvis in which a fetus develops). Most endometrial cancers are adenocarcinomas (cancers that begin in cells that make and release mucus and other fluids).
.

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 II trialA study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer. is studying radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with recurrent(ree-KER-ent KAN-ser)

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.
endometrial cancer.

Objectives

Primary

  1. Determine whether pelvic radiotherapy and cisplatin are more promising with respect to progression-free survival than pelvic radiotherapy alone in patients with recurrent endometrial cancer limited to the pelvis and vagina.

Secondary

  1. Compare the sites of recurrence in patients treated with these regimens.
  2. Compare overall survival of patients treated with these regimens.
  3. Compare the prognostic significance of the location (central pelvis versus vagina) and size of the recurrence, in addition to the prognostic significance in the salvage setting, in terms of histological subtype, grade, age, race, performance status, and the presence of lymph-vascular space involvement of the original tumor at the time of initial hysterectomy, in patients treated with these regimens.
  4. Compare the toxicity of these regimens in these patients.

Treatment Sites in Georgia

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