A Phase II Trial Evaluating Cisplatin (NSC#119875) and Gemcitabine (NSC #613327) Concurrent with Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva Save

Date Added
February 9th, 2015
PRO Number
Pro00025562
Researcher
David Griffin
Keywords
Cancer, Cancer/Gynecological, Drug Studies
Summary

The purpose of this study is to find out if radiation therapy along with the addition of the drugs, cisplatin and gemcitabine, works in treating locally advanced squamous cell carcinoma of the vulva and to find out what side effects or surgical complications are caused by treatment with this combination.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

Can Diet and Physical Activity Modulate Ovarian Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival? Save

Date Added
November 18th, 2014
PRO Number
Pro00039133
Researcher
Jennifer Young
Keywords
Cancer/Gynecological
Summary

This study is for women who have completed treatment (chemotherapy and other treatment) for state II, III, or IV ovarian, fallopian tube or primary peritoneal cancer (cancer having to do with the tissue that lines the inside of the abdomen and covers its organs) and are at risk for the cancer coming back.

Institution
MUSC
Recruitment Contact
Sarah Booker
843-792-9190
bookers@musc.edu

A Randomized Phase III Study Of Standard Vs. IMRT Pelvic Radiation For Post-Operative Treatment Of Endometrial And Cervical Cancer (TIME-C) Save

Date Added
October 31st, 2014
PRO Number
Pro00029828
Researcher
Samuel Cooper
Keywords
Cancer/Gynecological
Summary

This study is for adult female patients who have endometrial or cervical cancer that has a high risk of coming back in the pelvis or vagina. The purpose of this study is to test whether the use of a radiation therapy delivery technique called intensity-modulated radiation therapy (IMRT) can reduce the amount and severity of gastrointestinal side effects (such as diarrhea) that result from radiation, compared with standard radiation techniques. In this study, patients will get either the IMRT or the standard radiation. Patients in group 1 (often called "Arm A"), you will receive IMRT radiation therapy. This radiation technique is not the standard technique in this setting. The radiation therapy will be given once daily, 5 days a week, for 5-6 weeks. The treatment takes about 5-15 minutes each day. Patients may or may not receive weekly IV cisplatin chemotherapy (this will be decided by the study doctor). Patients in group 2 (often called "Arm B"), will receive standard three-dimensional radiation therapy. This is the standard radiation technique in this setting. The radiation therapy will be given once daily, 5 days a week, for 5-6 weeks. The treatment takes about 5-15 minutes each day. Patients may or may not receive weekly IV cisplatin chemotherapy (this will be decided by the study doctor).

Institution
MUSC
Recruitment Contact
Anne Wulf
843-792-9190
wulf@musc.edu

Using Serum HE4 and CA125 to Monitor the Therapeutic Effects in Ovarian Cancer Patients Based on Histological Subtypes Save

Date Added
August 26th, 2014
PRO Number
Pro00019893
Researcher
Yusheng Zhu
Keywords
Cancer, Cancer/Gynecological
Summary

This study is for female adult subjects with ovarian cancer. CA125 is a protein (compound made by the body) found in blood that is used to monitor treatments and disease progression in ovarian cancer patients. HE4 is also a protein that is used in the evaluation of ovarian cancer and disease monitoring. Both CA125 and HE4 are approved by the FDA to monitor the treatment of ovarian cancers. The purpose of this study is to investigate HE4 and CA125 expressions in different types of ovarian cancer and to evaluate the changes in HE4 and CA125 before and after treatment. A blood draw of approximately 5mL or 1 teaspoon will be taken from eligible subjects before surgery, before each course of chemotherapy and at the time of disease response assessment to evaluate HE4 and CA125 expression.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis Save

Date Added
August 5th, 2014
PRO Number
Pro00036914
Researcher
Patricia Griffin
Keywords
Bone, Cancer, Cancer/Brain, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Leukemia, Cancer/Lung, Cancer/Lymphoma, Cancer/Myeloma, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Spinal Cord
Summary

Multiple radiation treatments are frequently used to treat pain caused by cancer that has spread to the spine. Image-guided radiosurgery/stereotactic body radiation therapy (SBRT) is a treatment that uses highly focused x-rays to deliver a single high dose on a specific area of the body. Image-guided radiosurgery/SBRT uses special equipment to position the patient and guide the focused beams toward the area to be treated and away from normal tissue.

The purpose of this part of the study is to compare the effects, good and/or bad, of image-guided radiosurgery/SBRT to standard radiation therapy to find out which treatment provides the most rapid pain relief with the least side effects.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

A pilot study evaluating vitamin D deficiency and risk of aggressive uterine cancer in African American as compared to White women Save

Date Added
May 19th, 2014
PRO Number
Pro00030938
Researcher
Whitney Graybill
Keywords
Cancer/Gynecological, Women's Health
Summary

The purpose of this study is to evaluate vitamin D levels in African American and White women who present with a new diagnosis of uterine cancer.

Institution
MUSC
Recruitment Contact
Tamara Saunders
843-792-6992
saundert@musc.edu

Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials Save

Date Added
May 6th, 2014
PRO Number
Pro00034158
Researcher
Sharmila Mehta
Keywords
Cancer, Cancer/Brain, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Leukemia, Cancer/Lung, Cancer/Lymphoma, Cancer/Myeloma, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Education, Non-interventional
Summary

The purpose of this study is to find out if providing patients with educational materials helps them to be better prepared for making a decision about participating in a research study to treat their cancer.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer Save

Date Added
April 30th, 2014
PRO Number
Pro00034096
Researcher
Whitney Graybill
Keywords
Cancer/Gynecological, Women's Health
Summary

This study is for adult women who have advanced or recurrent endometrial (uterine) cancer. The purpose is to find out if the drug combination of paclitaxel, carboplatin and metformin works better than paclitaxel and carboplatin alone in treating uterine cancer.

Institution
MUSC
Recruitment Contact
Sarah Booker
843-792-9190
bookers@musc.edu

A PHASE III TRIAL OF ADJUVANT CHEMOTHERAPY AS PRIMARY TREATMENT FOR LOCALLY ADVANCED CERVICAL CANCER COMPARED TO CHEMORADIATION ALONE: THE OUTBACK TRIAL (ANZGOG 0902/GOG-0274/RTOG 1174) Save

Date Added
December 18th, 2013
PRO Number
Pro00016094
Researcher
Jennifer Young
Keywords
Cancer, Cancer/Gynecological
Summary

The objectives of this trial are to find out whether adjuvant chemotherapy (using two other drugs) after chemo-radiation will increase the chances of survival and reduce the risk of tumor recurrence in the pelvis and other places. The risk and severity of side effects and quality of life during and after treatment will also be evaluated and compared. This trial will help the researchers understand the safety and effectiveness of this new treatment regimen for cervical cancer.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NCS# 123127) v. Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma Save

Date Added
October 17th, 2013
PRO Number
Pro00026910
Researcher
Jennifer Young
Keywords
Cancer, Cancer/Gynecological
Summary

This study is for patients who have a specific kind of uterine cancer; called a leiomyosarcoma that was found only in the uterus; and which has been completely removed by surgery. In this study, we are looking to see if giving chemotherapy with gemcitabine plus docetaxel, followed by doxorubicin, to patients whose leiomyosarcoma was found only in the uterus, decreases the chance that the leiomyosarcoma will come back (recur). In this study half the patients will be managed in the standard way, which is to follow them closely with CT scans, and see if the disease ever comes back. The other half of the patients will be treated with chemotherapy and also followed to see if the disease comes back. Patients will be asked to visit the office for follow up exams approximately every four months for the first three years and then every six months for the next two years after enrollment on this study. At the end of this five year period we would like to keep track of the participants' medical condition for the rest of their lives by calling once a year to see how they are doing.

Institution
MUSC
Recruitment Contact
Anne Wulf
843-792-9190
wulf@musc.edu