Uterine Cancer

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Uterine Cancer Clinical Trials

General Purpose:

“Uterine cancer” is a generic term used to describe any malignant tumor that arises in the uterus. There are two types of uterine cancer: endometrial cancer and uterine sarcoma. Endometrial cancer arises in the endometrium, or tissue that lines the uterus. Endometrial cancers are classified according to their grade, which is determined by examining a tissue sample of the tumor under a microscope.

High-grade tumors tend to grow faster than low-grade tumors, which can help to estimate prognosis and guide treatment options. In addition to grade, the woman’s age and general health status are also taken into consideration when deciding on a method of treatment as well as determining the type of uterine cancer clinical trials she can volunteer for.

Uterine sarcoma is a rare type of uterine cancer that forms in the uterine muscle or other tissues. It most often occurs after menopause. There are two specific types of uterine sarcoma: leiomyosarcoma (which occurs in the muscle cells) and endometrial stromal sarcoma (which occurs in the connective tissue cells).

Research is currently focused on more effective methods of detecting and treating endometrial cancer. In addition, research is also looking into genetic influences that cause endometrial cancer to develop in the first place, as well as run in families. Finally, new surgical options for treatment are also being investigated. Uterine cancer research is focused on gaining a better understanding of how molecular and genetic changes lead to its development, as well as investigating the effectiveness of newly-developed drugs for its treatment.

What Will Uterine Cancer Clinical Trials Be Like?

Uterine cancer clinical trials may involve many common tests and procedures; however, the specific type of uterine cancer you have, and the ultimate design of the particular studyUterine Cancer Clinical Trials will determine which specific procedures you will undergo. Examples of specific tests and procedures that may be used in a clinical trial for uterine cancer include the following:

  • Physical exam and detailed family history information.
  • Pelvic exam
  • Pap smear
  • Blood and/or tissue sample for the purposes of conducting genetic testing.
  • If the study is evaluating a new type of medication or vaccine, blood and/or urine tests may be performed to monitor how your body metabolizes the medication or how effectively your body has responded to the vaccine.
  • Imaging procedures such computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans. These imaging procedures are non-invasive and provide detailed pictures of areas inside your body.   
  • Vaginal ultrasound
  • Abdominal ultrasound
  • Surgery
  • Biopsy
  • Quality of life assessments to evaluate how your cancer is impacting your ability to perform activities of daily living.
  • Pain assessments

Typical Uterine Cancer Clinical Trial Protocol:

There is a variety of research currently being conducted for women with uterine cancer. Sample clinical trials might include the following:

  • A clinical trial to compare the effectiveness of different types of radiation therapy following surgery to remove the uterus.
  • A clinical trial to compare the use of standard chemotherapy plus radiation therapy versus standard chemotherapy alone to treat endometrial cancer.
  • A clinical trial designed to evaluate if long-term use of hormonal contraceptives (e.g., birth control pills) is associated with an increased risk of endometrial cancer.
  • A study to evaluate genetic mutations in endometrial cancers and determine if the presence of certain mutations indicate a more favorable response to a particular chemotherapy drug.
  • A study to determine which type of surgical method used to remove the uterus leads to the fewest side effects for patients.
  • A long-term study to determine if healthy women with a specific genetic mutation known to be common in uterine sarcomas eventually develop the disease.
  • A clinical trial to evaluate if treatment with a chemotherapy drug that is effective against malignant brain tumors is equal to, or more effective, than standard chemotherapy for uterine sarcoma.
  • A quality of life study designed to evaluate the physical, psychological, and sexual impact of hysterectomy to treat uterine cancer.

A brief word about randomized trials and placebos:

Many clinical trials, such as uterine cancer clinical trials, involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

Uterine Cancer Clinical TrialsOn occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time in a specific cancer, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

This is rarely done in cancer clinical trials; however it may occasionally be necessary from a scientific standpoint. Placebo-only trials will only be done when ethically appropriate and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular type of cancer and clinical situation.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including Uterine Cancer Clinical Trialsyour disease stage, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you will want to have on hand include:

  • The name, location, size, stage, and cell type of your cancer, as well as the locations of any metastases you have. Also know these details for any prior cancer you have had.
  • Know your performance status, which estimates how well you perform normal activities of daily living. Examples: Karnofsky Performance Scale (KPS) and the ECOG scale.
  • Know your treatment history, including chemotherapy, radiation therapy, immunotherapy, and/or surgery.
  • Know your blood cell counts, liver function test results, and kidney function test results.

Suggested Search Terms:

Once you are ready to begin your search for uterine cancer clinical trials, it might be best to refine your search by combining either “endometrial cancer” or “uterine sarcoma” (depending on your diagnosis) with the following search terms: “treatment,” “chemotherapy,” “radiation therapy,” “management,” “surgery,” “advanced,” “grade,” “screening,” “sexual functioning,” “side effects,” “uterine cancer clinical trials.”  and “pain management.”

Current Search Term:

“Uterine Cancer”

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Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation

Condition:   Uterine Cancer
Interventions:   Drug: Letrozole;   Drug: Everolimus
Sponsor:   Greater Baltimore Medical Center
Active, not recruiting

A Study of Nivolumab in Selected Uterine Cancer Patients

Conditions:   Uterine Cancer;   Endometrial Carcinoma;   Carcinosarcoma;   Leiomyosarcoma;   Undifferentiated Sarcoma;   High Grade Endometrial Stromal Sarcoma
Intervention:   Drug: Nivolumab
Sponsors:   Memorial Sloan Kettering Cancer Center;   Bristol-Myers Squibb

Study of Pembrolizumab, Radiation and Immune Modulatory Cocktail in Cervical/Uterine Cancer

Conditions:   Cervical Cancer;   Endometrial Cancer;   Uterine Cancer
Interventions:   Drug: Pembrolizumab;   Radiation: Radiation;   Drug: Vitamin D;   Drug: Aspirin;   Drug: Lansoprazole;   Drug: Cyclophosphamide;   Dietary Supplement: Curcumin
Sponsors:   University Hospital, Ghent;   Kom Op Tegen Kanker;   Anticancer Fund, Belgium

Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers

Conditions:   Cervical Cancer;   Uterine Cancer
Interventions:   Drug: Cisplatin;   Procedure: Peritoneal mesometrial resection;   Procedure: Radical hysterectomy;   Radiation: Concurrent chemoradiation therapy (CCRT);   Procedure: Laterally extended endopelvic resection, Total mesometrial resection;   Procedure: Total mesometrial resection;   Drug: 5-fluorouracil, Cisplatin;   Drug: Doxorubicin, Cisplatin;   Procedure: Staging operation;   Radiation: Radiotherapy or Concurrent chemoradiation therapy (CCRT)
Sponsor:   Seoul National University Hospital

Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors

Conditions:   Cervical Cancer;   Uterine Cancer;   Ovarian Cancer
Intervention:   Device: PAMS I
Sponsor:   Seoul National University Hospital

Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer

Conditions:   Breast Carcinoma;   Endometrial Clear Cell Adenocarcinoma;   Endometrial Serous Adenocarcinoma;   Uterine Corpus Cancer;   Uterine Corpus Carcinosarcoma
Interventions:   Drug: Metformin Hydrochloride;   Drug: Doxycycline
Sponsor:   Sidney Kimmel Cancer Center at Thomas Jefferson University

Sentinel Node Mapping in Women With Cervical and Endometrial Cancer

Conditions:   Uterine Cervical Neoplasms;   Uterine Neoplasms
Intervention:   Procedure: Sentinel lymph node mapping
Sponsors:   University of Southern Denmark;   Odense University Hospital;   Danish Cancer Society

Sentinel Node Mapping in Women With Endometrial and Cervical Cancer

Conditions:   Uterine Cervical Neoplasms;   Uterine Neoplasms
Intervention:   Procedure: SLN mapping and removal of PET-positive lymph nodes
Sponsors:   University of Southern Denmark;   Odense University Hospital;   Danish Cancer Society

A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus

Condition:   Endometrial Cancer
Interventions:   Drug: Carboplatin AUC;   Drug: Abraxane
Sponsor:   New York University School of Medicine

Clinical Trial to Evaluate the Safety and Effectiveness of GDC-0032 When Given Alongside Tamoxifen

Conditions:   Breast Cancer;   Ovarian Cancer;   Cancer of the Uterus
Interventions:   Drug: GDC-0032;   Drug: Tamoxifen
Sponsors:   The Netherlands Cancer Institute;   Genentech, Inc.;   EurocanPlatform;   Rather

A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping

Conditions:   Endometrial Cancer;   Uterine Cancer;   Cervical Cancer
Intervention:   Device: PINPOINT
Sponsor:   Novadaq Technologies Inc.

Assisted Exercise in Obese Endometrial Cancer Patients

Conditions:   Stage I Endometrial Adenocarcinoma;   Uterine Cancer;   Obesity
Interventions:   Behavioral: Exercise on stationary recumbent exercise cycle;   Behavioral: Health Education;   Behavioral: Questionnaires;   Procedure: Neuroimaging;   Procedure: Genetic and Biomarkers
Sponsor:   Case Comprehensive Cancer Center

Phase Ib Study of Olaparib Plus Weekly Carboplatin and Paclitaxel in Relapsed Ovarian Cancer

Conditions:   Stage III Ovarian Cancer;   Stage IV Ovarian Cancer;   Uterine Cancer
Interventions:   Drug: Olaparib;   Drug: Carboplatin;   Drug: Paclitaxel
Sponsors:   Swedish Medical Center;   AstraZeneca
Active, not recruiting

Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix

Conditions:   Uterine Cancer;   Cervical Cancer
Intervention:   Radiation: Proton radiation therapy
Sponsors:   Massachusetts General Hospital;   National Cancer Institute (NCI)

Fosaprepitant Versus Aprepitant in the Prevention of Chemotherapy Induced Nausea and Vomiting

Conditions:   Ovarian Cancer;   Uterine Cancer
Interventions:   Drug: fosaprepitant;   Drug: aprepitant;   Other: Oral Placebo;   Other: IV placebo
Sponsors:   Gynecologic Oncology Associates;   Merck Sharp & Dohme Corp.

Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

Conditions:   Recurrent Uterine Sarcoma;   Uterine Carcinosarcoma
Interventions:   Drug: ixabepilone;   Other: laboratory biomarker analysis
Sponsor:   National Cancer Institute (NCI)
Active, not recruiting

Thermal Spread Into the Interstitial Portion of the Fallopian Tubes Using the Ligasure Device at Time of Hysterectomy

Conditions:   Cervical Cancer;   Ovarian Cancer;   Uterine Cancer
Intervention:   Device: LigaSure vessel sealing system
Sponsor:   Memorial Sloan Kettering Cancer Center

A Global Assessment of Medical, Emotional and Reproductive Concerns in Gestational Trophoblastic Disease Survivors

Conditions:   Uterine Cancer;   Cervix Uteri Nos;   Gestational Trophoblastic Disease
Intervention:   Behavioral: questionnaire
Sponsor:   Memorial Sloan Kettering Cancer Center
Active, not recruiting

A Phase II Study of Therapy With Paclitaxel, Carboplatin and Megesterol Acetate for the Management of Uterine Cancer

Condition:   Uterine Cancer
Intervention:   Drug: Paclitaxel ,Carboplatin , Megesterol Acetate
Sponsor:   University of Alabama at Birmingham

A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus

Condition:   Uterine Cancer
Intervention:   Drug: Paclitaxel and carboplatin combination
Sponsor:   University of Alabama at Birmingham

Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

Conditions:   Ovarian Cancer;   Fallopian Tube Cancer;   Primary Peritoneal Carcinoma;   Uterine Cancer
Intervention:   Drug: Paclitaxel, Cisplatin IP
Sponsor:   University of Oklahoma

Gleevec/Taxol for Patients With Uterine Papillary Serous Carcinoma

Condition:   Uterine Cancer
Interventions:   Drug: Imatinib Mesylate;   Drug: Paclitaxel
Sponsor:   M.D. Anderson Cancer Center

Intensity Modulated Radiotherapy (IMRT) for the Pelvis Post-Hysterectomy

Conditions:   Uterine Cancer;   Cervical Cancer;   Endometrial Cancer
Interventions:   Radiation: Intensity Modulated Radiotherapy (IMRT);   Procedure: CT Scan
Sponsor:   M.D. Anderson Cancer Center

Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus

Condition:   Mixed Mullerian Tumors of the Uterus
Interventions:   Drug: Gemcitabine;   Drug: Oxaliplatin;   Radiation: Radiation
Sponsors:   Dana-Farber Cancer Institute;   Sanofi;   Brigham and Women's Hospital;   Massachusetts General Hospital

Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma

Conditions:   Leiomyosarcoma;   Uterine Neoplasm
Intervention:   Drug: Letrozole
Sponsors:   M.D. Anderson Cancer Center;   Novartis

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