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Phase III Randomized Study of Adjuvant Radiation Versus Chemoradiation Therapy in Patients With Intermediate-Risk Stage I-IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy

Status
Active
Cancer Type
Cervical Cancer
Trial Phase
Phase III
Eligibility
18 and over, Female
Study Type
Treatment
NCT ID
NCT01101451
Protocol IDs
GOG-0263 (primary)
GOG-0263
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.
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 chemotherapy is more effective than radiation therapy alone in treating patients with 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 giving radiation therapy together with chemotherapy to see how well it works compared to radiation therapy alone in treating patients with stage I(... SER-vih-kul KAN-ser)

Cancer is found in the cervix only. Stage I is divided into stages IA and IB, based on the amount of cancer that is found. In stage IA, a very small amount of cancer that can only be seen with a microscope is found in the tissues of the cervix. The cancer is not deeper than 5 millimeters and not wider than 7 millimeters. In stage IB, the cancer is still within the cervix and either (1) can only be seen with a microscope and is deeper than 5 millimeters or wider than 7 millimeters; or (2) can be seen without a microscope and may be larger than 4 centimeters.
or stage II cervical cancer(... SER-vih-kul KAN-ser)

Cancer has spread beyond the cervix but not to the pelvic wall (the tissues that line the part of the body between the hips). Stage II is divided into stages IIA and IIB, based on how far the cancer has spread. In stage IIA, cancer has spread to the upper two thirds of the vagina but not to tissues around the uterus. In stage IIB, cancer has spread to the upper two thirds of the vagina and to the tissues around the uterus.
who previously underwent surgery.(SER-juh-ree)

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

Objectives

Primary

  1. To determine if post-operative adjuvant chemoradiotherapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in patients with intermediate-risk factors stage I-IIA cervical cancer after treatment with radical hysterectomy.

Secondary

  1. To compare the overall survival (OS) of patients treated with these regimens.
  2. To assess differences in incidence and severity of regimen-attributed adverse events in these patients.
  3. To provide assessment of patient risk vs benefit (positive study only).
  4. To determine whether post-operative adjuvant CRT improves the health-related quality-of-life compared to RT alone.
  5. To compare toxicity profiles with particular focus on treatment-related genitourinary, gastrointestinal, neurological, pain, and sexual adverse events in these patients.

Tertiary

  1. To bank archival tumor tissue for research studies, including studies that evaluate the association between biomarkers, RFS, OS, and clinical-surgical-pathologic characteristics in patients treated with these regimens.
  2. To bank DNA from whole blood for research studies, including studies that evaluate associations between single nucleotide polymorphisms (SNPs), and measures of clinical outcome, including RFS, OS, and adverse events in patients treated with these regimens.

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