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Note about eligibility details:
This is only a partial list of eligibility criteria. Please contact the Radiation Oncology Department at Northwestern Memorial Hospital for complete screening information if you are interested in this clinical trial.
The department of Radiation Oncology at Northwestern University supports and initiates numerous state-of–the-art clinical oncology trials that are funded through several entities, including the National Institutes of Health, pharmaceutical companies, and national cooperative trial groups. The latter include the Radiation Therapy Oncology Group, the Children's Oncology Group, the Eastern Cooperative Oncology Group, and the Gynecologic Oncology Group. In collaboration with the Robert H. Lurie Comprehensive Center, patients are cared for by physicians across multi-disciplinary specialties allowing them to receive the best care possible. The clinical research program implements clinical trials that span from pilot to phase IV studies with the ultimate goal of becoming a leader in pioneering and implementing new methods of treatments against the variety of cancers which exist.
| Breast |
NSABP B-43 |
William Small Jr., M.D. |
A Phase III Clinical Trial Comparing Trastuzumab GivenConcurrently with Radiation Therapy and RadiationTherapy Alone for Women with HER2-Positive DuctalCarcinoma In Situ Resected by Lumpectomy |
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Purpose
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Overview
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Eligibility
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Description of Treatment
Purpose
This study will find out if the addition of a medication known as Trastuzumab(Herceptin) to breast radiation therapy is more effective than radiation therapy without Trastuzumab in preventing occurrence of breast cancer in the same breast, in the other breast, or in other parts of the body in patients with HER2-positive DCIS.
Overview
DCIS is also known as intraductal or non-invasive breast cancer and is short for Ductal Carcinoma In-Situ.DCIS means that the cancer cells are only in the milk ducts in the breast and have not spread to other breast tissue or to other parts of the body. Radiation therapy is the standard treatment for patients with DCIS. Trastuzumab has been shown to block the HER2 protein and to slow down or stop the growth of HER2-positive “invasive” breast cancers. Trastuzumab is only known to be effective in treating breast cancer that is HER2-positive. Therefore, a patient’s tumor must be tested to find out if it is HER2-positive before she can join this study. HER2-positive means that the cancer makes too much of a protein called HER2. Too much of this protein can cause normal cells to receive extra growth signals. This can turn a normal cell into a cancer cell and can make cancer cells grow faster. Trastuzumab is considered to be investigational (still being researched) because the Food and Drug Administration has not approved it for use in the treatment of DCIS.
Eligibility
1) Participants cannot have a history of heart disease2) Participants must have ductal carcinoma in-situ (DCIS) that is HER2 positive 3) All the DCIS must have been resected (surgicallyremoved) by a procedure known as a lumpectomy 4) Participants must be 18 years of age or older
Description of Treatment
Participants for this study will be randomized into twogroups. Each group will receive radiation therapy. Receiving radiation therapy after a lumpectomy is part of regular cancer care for DCIS. Participant’s radiation therapy treatments will take 3 to 6 weeks to complete depending on the treatment schedule. Only one group will receive 2 doses of trastuzumab during the time period they receive radiation therapy. Participants will receive Dose 1 of trastuzumab within 1 week before starting radiation therapy. Three weeks after Dose 1 of trastuzumab, Dose 2 will be given. Trastuzumab is given through a vein (IV).
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| Breast |
RTOG 0413 |
William Small Jr., M.D. |
A Randomized Phase III Study of Conventional Whole BreastIrradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer |
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Purpose
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Overview
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Eligibility
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Description of Treatment
Purpose
The purpose of this study is to see if partial breast irradiation (PBI) is as good as orbetter than whole breast irradiation (WBI) in keeping cancer from coming back in the breast
Overview
Studies have shown that giving radiation therapy to the breast after lumpectomy helps keep cancer from coming back in the breast. Whole breast irradiation (WBI)is a standard treatment after a lumpectomy. WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial breast irradiation (PBI) is radiation therapy given only to the area of the breast where the cancer was removed. PBI is given 2 times a day on 5 days. PBI may be given over a period of 5 to 10 days. Early studies show that PBI may work as well as WBI. However, there has not been a study that directly compares PBI to WBI. This study will determine if the shorter PBI treatment time results in cancer returning in the breast more often than with WBI. It is also important to be sure that the way the breast looks after PBI is as good as or better than WBI.
Eligibility
1) Participants must be 18 years of age or older2) Subjects must have early stage ductal carcinoma in-situ (DCIS) or invasive carcinoma of the breast3) Subjects must have had a lumpectomy and must be enrolled into the study within 42 days from their last surgery
Description of Treatment
Subjects will be "randomized" into one of the two study groups: Group 1 or Group 2. Randomization means that subjects are put into a group by chance. Subjects in Group 1 will receive WBI. Subjects in Group 2 will receive PBI. Subjects in both groups may receive chemotherapy and hormonal therapy if their doctor decides it is necessary. Subjects in Group 1 will start WBI soon after joining the study, if they do not need chemotherapy. Subjects who need chemotherapy will be given the chemotherapy before radiation. After the chemotherapy is finished, subjects will receive WBI once a day for 5 days a week. WBI will last 5 to 7 weeks. Each study treatment lasts for 10 to 15 minutes. Subjects in Group 2 will start PBI soon after they join the study. The study treatment will be given 2 times a day, about 6 hours apart, on 5 days. The study treatments may be given over a period of 5 to 10 days. Each study treatment lasts for 10 to 15 minutes. There are 3 types of PBI but each subject will only receive one type. The study doctor will decide which type the subject can receive. If the subjects need chemotherapy, it will start after the PBI treatment is finished. For both Groups 1 and 2 if the subject's breast cancer is affected by hormones (estrogen or progesterone), the doctor will also give the subject at least 5 years of hormonal therapy.
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| Breast |
RTOG 1014 |
William Small Jr., M.D. |
A Phase II Study of Repeat Breast Preserving Surgery and3D-Conformal Partial Breast Re-Irradiation (PBRI) for Local Recurrence of Breast Carcinoma |
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Purpose
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Overview
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Eligibility
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Description of Treatment
Purpose
The purpose of this study is to evaluate the side effects of partial breastre-irradiation given after a lumpectomy.
Overview
The lumpectomy will remove the breast cancer and a limited amount of surrounding normal breast tissue. Following thesurgery, patients will receive three dimensional conformal radiation therapy (3D-CRT) to treat only the area in the breast where the lumpectomy was performed. 3D-CRT tries to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to the cancer and to areas that the study doctor thinks may have cancer cells.
Eligibility
1) Participants must be 18 years of age or older2) Participants must have had a lumpectomy of in-breast ipsilateral (cancer has returned to the same breast that hasbeen treated) and final breast surgery (lumpectomy and/orfinal re-excision) witin 42 days prior to study entry 3) Participants must have had an initial lumpectomy followed by whole breast radiation greater than 1 year prior to study entry
Description of Treatment
Participants will first have a lumpectomy. More surgery may benecessary if the lumpectomy does not remove all of the cancer. Within 9 weeks after the last breast surgery, participants will receive radiation therapy to the area of the lumpectomy 2 times per day for 15 consecutive working days. The radiation will be given 6 hours apart on each of the 15 days. Chemotherapy and/or hormonal therapy may be necessary depending on the size and extent of the tumor and other risk factors. Participation in this study will not influence whether or not participants receive such additional treatment.
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| Esophagus |
RTOG 0436 |
William Small Jr., M.D. |
A Phase III Trial Evaluating the Addition of Cetuximab toPaclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery |
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Purpose
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Overview
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Eligibility
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Description of Treatment
Purpose
The purpose of this study is to evaluate the safety and benefits of radiationtherapy plus chemotherapy, paclitaxel and cisplatin with or without the addition of cetuximab.
Overview
Cetuximab may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumordevelopment. Cetuximab is approved for the treatment of colorectal and head and neck cancers but is experimental for esophageal cancer. Cetuximab is investigational in this study.
Eligibility
1) Participants must be 18 years of age or older2) Participants must have cancer of the esophagus or gastroesophageal junction and must have been found to have cancer within 6 weeks prior to the study3) Participants cannot have had prior chemotherapy for esophageal cancer or prior radiation therapy tothe same are where the participant now has cancer
Description of Treatment
A computer program will place participants in one of thestudy groups through randomization. All participants will receive radiation. Radiation treatment will be given once a day, 5 days a week, for 5 and a half weeks. All participants will receive chemotherapy with paclitaxel and cisplatin starting the same day as the radiation treatments. Paclitaxel and cisplatin will be given through a vein in the arm once a week for 6 weeks (6 cycles). All treatments will be given as an outpatient.
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| Esophagus |
RTOG 1010 |
William Small Jr., M.D. |
A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma |
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Purpose
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Overview
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Eligibility
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Description of Treatment
Purpose
The purpose of this study is to compare the effects of the addition of trastuzumab to standard chemotherapy, radiation, and surgery for patients with HER2 positive esophageal cancer.
Overview
A standard treatment for esophagcancer of the esophagus is treatment with radiation therapy and the chemotherapy drugs paclitaxel and carboplatin. Afterwards surgery is done to remove the cancer by removing the esophagus. Trastuzumab is a drug that can only be effective in cancers that are HER2 positive. HER2 positive cancer means that the cancer has increased amounts of either HER2 genes or HER2 protein. Trastuzumab attaches to the HER2 protein. In patients with HER2 positive breast cancer, trastuzumab is proven to reduce cancer from growing back. However, the use of trastuzumab for esophageal cancer is experimental.
Eligibility
1) Participants must be at least 18 years of age.
2) Participants must be diagnosed with cancer of the esophagus.
3) Participants must not have had any prior radiation for esophageal cancer or prior chest radiotherapy.
Description of Treatment
Eligible participants will be "randomized" into one of two study groups described below. Randomization means put into a group by chance. Neither participant nor study doctor can choose the group. All participants will receive radiation once a day, 5 days a week, for 5 and a half weeks. Starting the same day as radiation treatments, all participants will receive paclitaxel and carboplatin once a week for 6
weeks. Paclitaxel and carboplatin will be injected into a vein. Participants in group 1 will also receive the drug trastuzumab. Starting
the same day as the first dose of radiation, paclitaxel, and carboplatin, group 1 will be given trastuzumab by vein as an outpatient. Participants in group 2 will not receive trastuzumab. Participants will be treated with radiation paclitaxel, and carboplatin.
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| Prostate |
RTOG 0534 |
John Kalapurakal, M.D. |
A Phase III Trial of Short Term Androgen Deprivation withPelvic Lymph Node or Prostate Bed Only Radiotherapy (SPORT) in Prostate Cancer Patients with A Rising PSA After A Radical Prostatectomy |
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Purpose
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Overview
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Eligibility
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Description of Treatment
Purpose
The purpose of this study is to compare the effects of three treatment methodson prostate cancer. There are 3 treatment groups in this study, participants who received radiation therapy to the prostate bed only, participants who received hormone therapy for 4 to 6 months plus radiation therapy to the prostate bed, and participants who receive hormone therapy for 4 to 6 months plus radiation therapy to the prostate bed and to the pelvic lymph nodes.
Overview
Currently, external beam radiation therapy is one of the standard treatments for men with prostate cancer who have arising PSA after surgery. PSA, Prostate Specific Antigen, is a protein found in the blood that can detect cancer. Different methods of radiation therapy are used, and it is not known which one is best. Most commonly, the area where the prostate was originally located before being removed (the prostate bed) is treated, without treating the lymph nodes in the pelvis. Prostate cancer can spread to the lymph nodes. There is some evidence in men who have not had surgery that radiotherapy to the pelvic lymph nodes may stop the cancer from spreading under some conditions. Since treating the pelvic lymph nodes can result in increased side effects, the benefit of this method of radiation therapy needs to be tested. In relation to external beam radiation, hormone therapy or drugs that reduce the testosterone in men can cause some prostate cancer cells to die and others to become sick and stop growing. Prostate cancer works by feeding on male hormones, such as testosterone. Therefore, it is believed that men who are treated with a combination of hormone therapy and radiation therapy will have a greater chance of not having their cancer return when compared to men treated with radiation alone.
Eligibility
1) Participants must be 18 years of age or older2) Participants must have prostate cancer that has been treated primarily with radical prostatectomy (complete removal of the prostate). Participants cannot have distant metastatic disease (disease that has spread well beyond the prostate).3) Participants cannot have AIDS. The study treatment may increase toxicity in blood and increase immunosuppression.4) Participants cannot have previous pelvic radiotherapy. There are also certain criteria related to prior androgen deprivation therapy. This should be discussed with the study doctor.5) Participants must have a PSA of at least 0.2 ng/mL but less than 2.0 ng/mL at least 6 weeks after their prostatectomy.6) Participants must have a Gleason score of 8 or less.
Description of Treatment
Participants will be randomized into one of three studygroups. Randomization means participants are put into a group by chance by a computer. Each treatment option will involve radiation treatments over 7–8 weeks. Participants of Group 1 will receive radiation treatments to the prostate bed once daily, 5 days a week, Monday through Friday, for a total of 36 to 39 treatments. Each radiation treatment will take 15-30 minutes. Participants of Group 2 will receive radiation treatments to the prostate bed once daily, 5 days a week, Monday through Friday, for a total of 36 to 39 treatments. Each radiation treatment will take 15-30 minutes. Participants of Group 3 will receive radiation treatments to the pelvic lymph nodes and prostate bed once daily, 5 days a week, Monday through Friday, for 25 treatments. From that point on, the radiation treatments will target the prostate bed only, 5 days per week, for another 11-14 treatments. The total number of radiation treatments will be 36 to 39 treatments. Each radiation treatment will take 15-30 minutes. In addition to radiation treatment, participants of Groups 2 and 3 will receive hormone therapy for 4 to 6 months. The hormone therapy will begin 2 months before the start of the radiation treatments. There are two parts to the hormone therapy. Participants will take injections either under the skin or in the muscle, and will take a pill, either flutamide three times per day or bicalutamide once per day. The pills will be taken for at least 4 of the 6 months.
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| Prostate |
RTOG 0815 |
John Kalapurakal, M.D. |
A Phase III Prospective Randomized Trial of Dose-EscalatedRadiotherapy with or without Short-Term Androgen Deprivation Therapy for Patients with Intermediate Risk Prostate Cancer |
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Purpose
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Overview
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Eligibility
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Description of Treatment
Purpose
The purpose of this study is to compare the effects of increasing the dose ofradiation therapy with or without hormone therapy on prostate cancer.
Overview
Prior studies have suggested possible advantages to the administration of hormonal therapy with radiation. However,those studies were performed with radiation techniques that do not match those commonly used in clinical practice today (that is, dose-escalated radiotherapy). Therefore, in this study, researchers will be testing to see if similar benefits for hormonal therapy are seen when used with current radiation therapy techniques.
Eligibility
1) Participants must be 18 years of age or older2) Participants must be male3) Participants must have prostate cancer
Description of Treatment
Participants are, by chance, put into one of the study groupsdescribed below. Neither participant nor study doctor can choose the group participants will be in. Group 1 (often called "Arm 1") will receive radiation treatments to the prostate gland and surrounding tissuesonce daily, 5 days a week, Monday through Friday, for a total of 44 treatments. If participants receive brachytherapy (permanent or temporary radiation seed implant) plus external beam radiation therapy, the total number of daily treatment sessions will be 25, instead of 44. Group 2 (often called "Arm 2") will receive radiation treatments to the prostate gland and surrounding tissues as specified under group 1 above. Participants also will receive hormone therapy for 6 months. There are two parts to the hormone therapy. Participants will take injections, either under the skin or in the muscle (typically every 1 to 3 months), of a luteinizing hormone-releasing hormone (LHRH) agonist. In addition, participants will take a pill, either flutamide three times per day or bicalutamide once per day.
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| Cervix |
RTOG 0724 |
William Small Jr., M.D. |
Phase III Randomized Study of Concurrent Chemotherapy andPelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy |
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Purpose
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Overview
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Eligibility
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Description of Treatment
Purpose
The purpose of this study is to compare the effects, good and/or bad, of givingadditional chemotherapy to patients after the usual treatment of chemotherapy and radiation for cervical cancer.
Overview
The standard treatment for your type of cervical cancer is cisplatin chemotherapy plus radiation. The study willdetermine whether adding chemotherapy with carboplatin and paclitaxel (experimental for your type of cervical cancer) to standard radiation and cisplatin chemotherapy improves survival without significantly increasing side effects. Cisplatin, carboplatin, and paclitaxel are FDA (Food and Drug Administration) approved drugs used to treat a number of different types of cancers, however carboplatin and paclitaxel are not standardly used in the treatment of cervical cancer.
Eligibility
1) Participants must be 18 years of age or older2) Participants must have undergone radical hysterectomy prior to entering the study 3) Participants cannot be allergic to carboplatin, paclitaxeland/or cisplatin
Description of Treatment
Participants will be randomized by computer software intoone of two groups. Participants in group 1 will receive radiation plus weekly cisplatin. Radiation will be given every day, 5 days a week. The cisplatin chemotherapy that will be given with the radiation therapy will be given, every Monday or Tuesday for 6 cycles. Participants in the group 2 will receive radiation plus weekly cisplatin as described for group 1. Participants will have 4 to 6 weeks of no drug and then will receive more chemotherapy with carboplatin and paclitaxel. Participants will receive both drugs on the same day every 3 weeks for 4 cycles.
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| Pancreas |
RTOG 0848 |
William Small Jr., M.D. |
A Phase III Trial Evaluating Both Erlotinib and Chemoradiation asAdjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma |
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Purpose
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Overview
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Eligibility
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Description of Treatment
Purpose
This study will compare the effects, good and/or bad, of the drug erlotinib incombination with gemcitabine to gemcitabine alone, as well as the roll of radiotherapy, for patients with pancreatic cancer that was removed by surgery to find out which is better.
Overview
The standard treatment for patients with pancreatic cancer that was removed by surgery is to receive the chemotherapydrug gemcitabine with or without radiotherapy. Recent clinical trials have been evaluating a new drug erlotinib, as well as radiation with chemotherapy, to prevent the cancer from returning after surgery. Erlotinib is a pill that may help treat cancers by blocking a gene that is important in cancer growth. The use of erlotinib to prevent the recurrence of pancreatic cancer after surgery is investigational.
Eligibility
1) Participants must be 18 years of age or older2) Participants must have had head of pancreas adenocarcinoma that was removed by surgery 3) Participant must not have had prior chemotherapy or radiation therapy for their pancreatic cancer
Description of Treatment
All participants will be assigned to one of two treatment groups.Participants in Group 1 will receive gemcitabine weekly, by vein, for 3 weeks, then will have 1 week off. This one month period is one cycle. These cycles will continue for 5 months. Participants in Group 2 will receive gemcitabine as described in Group 1, but will also get erlotinib, which is a pill to be taken every day for 5 months. Upon completion of 5 months of treatment, tests will be performed to determine if the cancer has grown back. The study will be completed at this time if the cancer has returned. If, after 5 months of chemotherapy, the cancer has not grown back, participants will be allowed to receive additional treatments, and will be assigned to Group 3 or Group 4. Participants in Group 3 will get one additional cycle of the same chemotherapy received in the first 5 months of this study (either gemcitabine alone or gemcitabine with erlotinib). Those in Group 4 will also get one additional cycle of the same chemotherapy received in the first 5 months of this study. In addition, participants will receive radiation therapy for 5 1/2 weeks and will take fluoropyrimidine during the radiation (this is a drug that makes the radiation work better).
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| Uterine |
RTOG 0921 |
William Small Jr., M.D. |
A Phase II Study of Postoperative Intensity Modulated RadiationTherapy (IMRT) with Concurrent Cisplatin and Bevacizumab Followed by Carboplatin and Paclitaxel for Patients with Endometrial Cancer |
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Purpose
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Overview
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Eligibility
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Description of Treatment
Purpose
The purpose of this study is to compare the effects, good and/or bad, of ananti-cancer drug called bevacizumab when added to standard chemotherapy and intensity-modulated radiation therapy (IMRT) to treat endometrial cancer.
Overview
The standard treatment for endometrial cancer involves use of radiation and chemotherapy. This study adds twomedications (bevacizumab and cisplatin) to the standard treatment. Bevacizumab may block cancer cells from making new blood vessels. It may also help standard chemotherapy and radiation work better. Bevacizumab has been approved by the FDA (Food & Drug Aministration) for use in several other types of cancer. However, the use of bevacizumab with chemotherapy and radiation in endometrial cancer is experimental. Bevacizumab is the common name for the commercial drug Avastin®. Standard radiation techniques cannot avoid delivering radiation to some of the normal tissues that surround the tumor. In this study, radiation will be given using a technique called IMRT. IMRT is an advanced delivery technique intended to lower the amount of radiation that the normal tissues receive, possibly reducing unwanted side effects. IMRT still delivers the desired amount of radiation to the areas that of cancer cells, such as lymph nodes.
Eligibility
1) Participants must be 18 years of age or older2) Participants must have had a hysterectomy with ovaryremoval for endometrial cancer within 56 days prior to study entry3) Participants must have been diagnosed with endometrialcancer
Description of Treatment
All participants in this study will receive a combination of bevacizumab,cisplatin (a standard chemotherapy drug), and intensity-modulated radiation therapy (IMRT). After the first treatment with bevacizumab, cisplatin and IMRT, the study doctor may decide that additional radiation is needed. This radiation is given in a manner that is more local to the effected tissue. This additional radiation may not be necessary for all participants. After this treatment with chemotherapy and radiation (and additional radiation if needed) is completed, two other chemotherapy drugs will be given. Carboplatin and Paclitaxel will be given at three week intervals four times.
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