Surgery Clinical Trials

  • Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

    RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancerand may have fewer side effects and improve recovery. Radiation therapy uses high-energy xrays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cellsthat remain after surgery.

    PURPOSE: This phase II trial studies how well breast-conserving surgery and radiationtherapy work in treating patients with multiple ipsilateral breast cancer

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  • Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

    This phase III clinical trial studies two different dose schedules of paclitaxel to see howwell they work in combination with carboplatin with or without bevacizumab in treatingpatients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, orfallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, workin different ways to stop the growth of tumor cells, either by killing the cells, bystopping them from dividing, or by stopping them from spreading. Bevacizumab is a type ofdrug called a monoclonal antibody and blocks tumor growth by stopping the growth of bloodvessels that tumors need to grow. It is not yet known whether giving paclitaxel withcombination chemotherapy once every three weeks is more effective than giving paclitaxelonce a week in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.

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  • Observation or Radiation Therapy and/or Chemotherapy and Second Surgery in Treating Children Who Have Undergone Surgery for Ependymoma

    RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly tothe tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used inchemotherapy use different ways to stop tumor cells from dividing so they stop growing ordie. Giving chemotherapy before surgery may shrink the tumor so that it can be removedduring surgery.

    PURPOSE: Phase II trial to determine the effectiveness of specialized radiation therapyeither alone or after chemotherapy and second surgery in treating children who haveundergone surgery for localized ependymoma.

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  • Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors

    This phase III trial is studying surgery followed by combination chemotherapy to see howwell it works in treating children with germ cell tumors that are not located in the head.Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stopgrowing or die. Combining more than one drug, and giving them after surgery, may kill anyremaining tumor cells following surgery. It is not yet known whether combinationchemotherapy is effective in decreasing the recurrence of childhood germ cell tumors.

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  • Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass

    A study to evaluate levosimendan compared with placebo in reducing the composite event rateof all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist(IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgeryon cardiopulmonary bypass (CPB).

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  • Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

    This phase III trial is studying observation to see how well a risk based treatment strategyworks in patients with soft tissue sarcoma. In the study, patients are assigned to receivesurgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes,after surgery, the tumor may not need additional treatment until it progresses. In thiscase, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumorcells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in differentways to stop the growth of tumor cells, either by killing the cells or by stopping them fromdividing. Giving chemotherapy and radiation therapy before surgery may make the tumorsmaller and reduce the amount of normal tissue that needs to be removed. Giving thesetreatments after surgery may kill any tumor cells that remain after surgery.

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  • Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors

    RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells fromdividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrinkthe tumor so that it is no longer present by conventional imaging and tumor markers fromserum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumorcells. Peripheral stem cell transplantation may allow the doctor to give higher doses ofchemotherapy drugs and kill more tumor cells. Combining different types of therapy may killmore tumor cells.

    PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or withoutsurgery and with or without high dose chemotherapy and peripheral stem cell transplantation,can increase response rates prior to radiation therapy and increase progression free andoverall surviving patients with newly diagnosed intracranial germ cell tumors.

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  • Imaging During Surgery in Diagnosing Patients With Prostate, Bladder, or Kidney Cancer

    This pilot clinical trial studies imaging during surgery in diagnosing patients withprostate, bladder, or kidney cancer. New diagnostic imaging procedures, may find prostate,bladder, or kidney cancer

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  • Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma

    This randomized phase III trial is studying combination chemotherapy followed by surgery andtwo different combination chemotherapy regimens with or without PEG-interferon alfa-2b tocompare how well they work in treating patients with osteosarcoma. Drugs used inchemotherapy work in different ways to stop the growth of tumor cells, either by killing thecells or by stopping them from dividing. Giving more than one drug (combinationchemotherapy) may kill more tumor cells. Biological therapies, such as PEG-interferonalfa-2b, may interfere with the growth of tumor cells. Giving combination chemotherapybefore surgery may shrink the tumor so it can be removed. Giving combination chemotherapytogether with PEG-interferon alfa-2b after surgery may kill any remaining tumor cells. It isnot yet known whether giving combination therapy together with PEG-interferon alfa-2b ismore effective than two different combination chemotherapy regimens alone after surgery intreating osteosarcoma.

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  • Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer

    This randomized phase III clinical trial studies chemotherapy with or without trastuzumabafter surgery to see how well they work in treating women with invasive breast cancer. Drugsused in chemotherapy work in different ways to stop the growth of tumor cells, either bykilling the cells, by stopping them from dividing, or by stopping them from spreading.Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgerymay kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancergrowth in different ways. Some block the ability of tumor cells to grow and spread. Othersfind tumor cells and help kill them or carry tumor-killing substances to them. It is not yetknown whether combination chemotherapy is more effective with trastuzumab in treating breastcancer.

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  • Measuring the Amount of Methadone or Morphine in the Blood of Neonates, Infants & Children After Cardiac Surgery.

    Study Population:

    Neonates, infants and children from birth to 5 years of age undergoing cardiac surgery withCPB.

    The use of methadone to provide analgesia may be increasing due to advantages compared toother commonly used opioid analgesic drugs. While efficacy of methadone has been reported inadults, there is a paucity of information in neonates and infants. In the latter population,fentanyl and morphine are most commonly used for opioid analgesia following major surgery,while methadone is frequently used for weaning of opioid dependent and tolerant patients, inspite of the paucity of knowledge of methadone pharmacology in this population. There areseveral clinical problems associated with fentanyl and morphine, and methadone may offersuperior efficacy with fewer side effects than these agents. We propose to study thepharmacokinetics (PK) and pharmacodynamics (PD) of methadone in neonates and infants in theintensive care unit following cardiac surgery.

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  • Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery

    Children with congenital heart defects often need cardiac surgery with cardiopulmonarybypass (the "heart-lung machine"). Approximately 35 to 50% of these children will have"acute kidney injury," or damage to the kidneys, after the procedure. We currently have fewmedications to prevent this kidney injury. The hypothesis of this study is that givingaminophylline after heart surgery can decrease the acute kidney injury.

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  • Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery

    This randomized phase III trial studies standard or comprehensive radiation therapy intreating patients with early-stage breast cancer who have undergone surgery. Radiationtherapy uses high-energy x rays to kill tumor cells. It is not yet known whethercomprehensive radiation therapy is more effective than standard radiation therapy intreating patients with breast cancer

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  • Cisplatin-Based Chemotherapy and/or Surgery in Treating Young Patients With Adrenocortical Tumor

    This phase III clinical trial is studying how well cisplatin-based chemotherapy and/orsurgery works in treating young patients with stage I, stage II, stage III or stage IVadrenocortical cancer. Drugs used in chemotherapy, such as cisplatin, work in different waysto stop the growth of tumor cells, either by killing the cells or by stopping them fromdividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.Giving chemotherapy before surgery may make the tumor smaller and reduce the amount ofnormal tissue that needs to be removed. Giving it after surgery may kill any tumor cellsthat remain after surgery.

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  • Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries

    RATIONALE: Zoledronate may prevent bone loss in patients who are undergoing surgery toremove the ovaries.

    PURPOSE: This randomized phase II trial is studying zoledronate to see how well it workscompared to observation in maintaining bone mineral density in patients who are undergoingsurgery to remove both ovaries.

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  • Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer

    RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumorcells, either by killing the cells or by stopping them from dividing. Giving chemotherapybefore surgery may make the tumor smaller and reduce the amount of normal tissue that needsto be removed.

    PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node andaxillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, orstage IIIB breast cancer.

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  • Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer

    RATIONALE: Surgery with or without internal radiation therapy may be an effective treatmentfor non-small cell lung cancer. Internal radiation uses radioactive material placed directlyinto or near a tumor to kill tumor cells. Stereotactic body radiation therapy may be able tosend x-rays directly to the tumor and cause less damage to normal tissue. It is not yetknown whether stereotactic body radiation therapy is more effective than surgery with orwithout internal radiation therapy in treating non-small cell lung cancer.

    PURPOSE: This randomized phase III trial is studying how well surgery with or withoutinternal radiation therapy works compared with stereotactic body radiation therapy intreating patients with high-risk stage IA or stage IB non-small cell lung cancer.

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  • Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

    This randomized phase III trial studies carboplatin, paclitaxel and gemcitabinehydrochloride when given together with or without bevacizumab after surgery to see how wellit works in treating patients with ovarian epithelial cancer, primary peritoneal cavitycancer, or fallopian tube cancer that has come back. Drugs used in chemotherapy, such ascarboplatin, paclitaxel and gemcitabine hydrochloride work in different ways to stop thegrowth of tumor cells, either by killing the cells, by stopping them from dividing, or bystopping them from spreading. Monoclonal antibodies, such as bevacizumab, may block tumorgrowth in different ways by targeting certain cells. It is not yet known whether combinationchemotherapy is more effective when given with or without bevacizumab after surgery intreating patients with ovarian epithelial cancer, primary peritoneal cavity cancer, orfallopian tube cancer.

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  • Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

    This randomized phase III trial studies bevacizumab and intravenous (given into a vein)chemotherapy to see how well they work compared with bevacizumab and intraperitoneal (giveninto the abdominal cavity) chemotherapy in treating patients with stage II-III ovarianepithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonalantibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread byblocking the growth of new blood vessels necessary for tumor growth. Drugs used inchemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stopthe growth of tumor cells, either by killing the cells or by stopping them from dividing. Itis not yet known whether giving bevacizumab together with intravenous chemotherapy is moreeffective than giving bevacizumab together with intraperitoneal chemotherapy in treatingpatients with ovarian epithelial cancer, fallopian tube cancer, or primary peritonealcancer.

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  • Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma

    RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells fromdividing so they stop growing or die. Giving combination chemotherapy before surgery mayshrink the tumor so that it can be removed. Giving combination chemotherapy after surgerymay kill any remaining tumor cells.

    PURPOSE: This phase II trial is studying how well surgery and/or combination chemotherapywork in treating children with fibrosarcoma.

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