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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Pilot Study to Assess the Potential Clinical Utility of 18F Fluciclovine PET for Cervical and Endometrial Cancer.

Conditions:   Cervical Cancer;   Uterine Cancer
Interventions:   Drug: 18F fluciclovine;   Device: 18F fluciclovine PET
Sponsors:   Nghi Nguyen;   Blue Earth Diagnostics
Not yet recruiting

A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Relapsed/ Refractory Endometrioid Endometrial or Endometrioid Ovarian Cancer (P204)

Conditions:   Endometrial Cancer;   Uterine Cancer;   Ovarian Cancer
Interventions:   Drug: Paclitaxel;   Drug: DKN-01
Sponsor:   Leap Therapeutics, Inc.

WEE1 Inhibitor AZD1775, External Beam Radiation Therapy, and Cisplatin in Treating Patients With Cervical, Vaginal, or Uterine Cancer

Conditions:   Endometrioid Adenocarcinoma;   Recurrent Cervical Carcinoma;   Stage I Uterine Corpus Cancer AJCC v7;   Stage I Vaginal Cancer AJCC v6 and v7;   Stage IA Uterine Corpus Cancer AJCC v7;   Stage IB Cervical Cancer AJCC v6 and v7;   Stage IB Uterine Corpus Cancer AJCC v7;   Stage II Cervical Cancer AJCC v7;   Stage II Uterine Corpus Cancer AJCC v7;   Stage II Vaginal Cancer AJCC v6 and v7;   Stage IIA Cervical Cancer AJCC v7;   Stage IIB Cervical Cancer AJCC v6 and v7;   Stage III Cervical Cancer AJCC v6 and v7;   Stage III Uterine Corpus Cancer AJCC v7;   Stage III Vaginal Cancer AJCC v6 and v7;   Stage IIIA Cervical Cancer AJCC v6 and v7;   Stage IIIA Uterine Corpus Cancer AJCC v7;   Stage IIIB Cervical Cancer AJCC v6 and v7;   Stage IIIB Uterine Corpus Cancer AJCC v7;   Stage IIIC Uterine Corpus Cancer AJCC v7
Interventions:   Drug: Adavosertib;   Drug: Cisplatin;   Radiation: External Beam Radiation Therapy;   Other: Laboratory Biomarker Analysis;   Other: Pharmacological Study
Sponsor:   National Cancer Institute (NCI)

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

Trial of Atezolizumab and Vigil for Advanced Gynecological Cancers (A Companion Study to CL-PTL-119)

Conditions:   Advanced Gynecological Cancers;   Ovarian Cancer;   Cervical Cancer;   Uterine Cancer
Interventions:   Biological: Vigil;   Drug: Atezolizumab
Sponsors:   Gradalis, Inc.;   Roche-Genentech

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
Active, not recruiting

Cancer of the Uterus and Treatment of Stress Urinary Incontinence

Conditions:   Endometrial Cancer;   Stress Urinary Incontinence
Sponsors:   Women and Infants Hospital of Rhode Island;   University of Alabama at Birmingham;   Hartford Hospital
Active, not recruiting

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.

Oral Iron vs. Placebo in Newly Diagnosed Gynecologic Oncology Patients Who Are Surgical Candidates.

Conditions:   Ovarian Cancer;   Cervical Cancer;   Uterine Cancer;   Anemia
Interventions:   Other: Oral Ferrous Fumarate;   Other: Placebo
Sponsor:   Sunnybrook Health Sciences Centre

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)

Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy

Conditions:   Breast Cancer;   Colorectal Cancer;   Ovarian Cancer;   Uterine Cancer
Intervention:   Behavioral: Mindfulness Based Cancer Recovery
Sponsor:   Masonic Cancer Center, University of Minnesota

Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer

Conditions:   Recurrent Uterine Corpus Sarcoma;   Uterine Carcinosarcoma
Intervention:   Drug: Pazopanib Hydrochloride
Sponsor:   National Cancer Institute (NCI)

Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy

Conditions:   Cervical Cancer;   Uterus Cancer;   Ovarian Cancer
Interventions:   Procedure: gynecologic surgery - standard coelioscopy;   Procedure: gynecologic surgery - robot assisted coelioscopy
Sponsors:   Centre Oscar Lambret;   CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie
Active, not recruiting

Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

Conditions:   Recurrent Uterine Corpus Sarcoma;   Uterine Carcinosarcoma
Interventions:   Drug: Ixabepilone;   Other: Laboratory Biomarker Analysis
Sponsor:   National Cancer Institute (NCI)

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

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

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

Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer

Conditions:   Recurrent Uterine Sarcoma;   Uterine Carcinosarcoma
Interventions:   Drug: imatinib mesylate;   Other: laboratory biomarker analysis
Sponsor:   National Cancer Institute (NCI)

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