Search Results
Phase III Trial of Concurrent Chemoradiotherapy with or without Atezolizumab (PSCI# 19-044)
The purpose of this study is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab, which is used to treat bladder cancer. The combination of chemotherapy, radiation therapy and the immunotherapy atezolizumab is considered experimental.
The purpose of this study is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab, which is used to treat bladder cancer. The combination of chemotherapy, radiation therapy and the immunotherapy atezolizumab is considered experimental.If you decide to take part in this study, you will receive combined chemotherapy and radiation therapy which is called “chemoradiotherapy” either with or without the study drug. The chemoradiotherapy you will receive is standard of care and what your doctor thinks is best. You will receive chemoradiotherapy for up to 7 weeks. If you are assigned to the group receiving study drug, you will take the drug for up to 6 months in addition the chemoradiotherapy.Your doctor will continue to follow your condition for up to 5 years after you register to the study, even though you have finished treatment in the first year. Your doctor will watch you for side effects and to see how your cancer affects you. You will have clinic visits at 3 months from the time you stop taking treatment for the first two years and then twice a year for the third year and once a year thereafter until 5 years after you register to the study
Patients must undergo radiological staging within 70 days prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must not have evidence of T4bN1-3 disease.
Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified.
Female patients of childbearing potential must have a serum pregnancy test prior to randomization.
Patients must be ≥ 18 years of age.
Patients must not have received prior treatment for muscle invasive bladder cancer including neoadjuvant chemotherapy for the current tumor.
Patients must not have a major surgical procedure within 28 days prior to randomization.
Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Patients must have adequate bone marrow function as evidenced by all of the following: ANC ≥ 1,500/microliter (mcL); platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL. These results must be obtained within 28 days prior to randomization.
PSCI 23-020: EA8212 A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)
If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy.
If you decide to take part in this study, you will either get Gemcitabine and Docetaxel instilled through a catheter weekly in your bladder for up to 6 weeks, or you will get BCG instilled weekly in your bladder for up to 6 weeks. Your initial therapy may be followed with maintenance therapy.After you finish your treatment, your doctor will continue to follow your condition for 5 years with a combination of cystoscopies (inserting a telescope in your bladder) and CT scans (to take images of your body) in order to detect cancer recurrence.
Patient must have histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HgTa, HGT1, CIS, HgTa + CIS, or HGT1 + CIS stage)
Patient must have ECOG Performance Status 0-2.
Patient must have all visible papillary tumor resected by the treating urologist at the site registering the patient to this protocol prior to randomization.
Patient may have received prior systemic gemcitabine or docetaxel use if it was for a non-bladder malignancy
Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT.
Patient must not have pure squamous cell carcinoma or adenocarcinoma.
Patient must not have any component of neuroendocrine carcinoma (i.e., small cell or large cell).
Patient must not have any component of sarcomatoid, micropapillary, or plasmacytoid variant histology.
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis
This study is being conducted to determine the efficacy, safety and tolerability of subcutaneous (applied under the skin) dosing of an experimental drug named ABC008 in subjects with inclusion body myositis (IBM).
Eligible subjects will be randomized into four different groups with one of two dose levels of the study drug or matching placebo. The study drug will be given by injection every eight weeks. At the safety follow-up visit, subjects will have the option to enroll in a long-term extension study.
$1137
Able to read, understand, and provide signed informed consent prior to the performance of any study-related procedures
Willing and able to comply with the requirements of the protocol, including traveling to the site for study-related assessments and SC injections, and using electronically administered diaries and questionnaires
Weight >40 and <115 kg
Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, or probable IBM
Any condition, e.g., severe degenerative arthritis with limited range of motion, which precludes the ability to quantitate muscle strength or perform functional assessments (e.g., mTUG,) in the Investigator’s opinion
Presence of another autoimmune or autoinflammatory disease other than indication under study
Major surgery within 12 weeks before Screening, major surgery planned during the study period, or any surgery planned during the study period
Initiation of an exercise or a physical therapy regimen within 4 weeks of Screening. Any exercise or physical therapy regimen initiated prior to the Screening Visit must have been stable for at least 4 weeks prior to Screening
PSCI 23-092 EA8192 A Phase II/III trial of Durvalumab and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
This trial is comparing outcomes of cisplatin eligible vs cisplatin ineligible high grade urothelial cancer patients treated with accelerated therapy vs gemcitabine and durvalumab followed by surgery.
Participants will need to complete all study visits, agree to having surgery and to make sure to tell the study team if they are having any side effects.
Patient must have the ability to understand and the willingness to sign a written informed consent document
Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy
Patients must not have any component of small cell/neuroendocrine carcinoma
Patients must not be pregnant or breast-feeding
Patient must not have another active (or within two years) second malignancy
Patient may have a history of resectable urothelial cancer
Patient must not have any uncontrolled illness
Patient must not have received prior systemic anthracycline therapy
PSCI 23-099 NRG-BR009: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancerand an Oncotype Recurrence Score ≤ 25 (OFSET)
To determine if chemotherapy added to ovarian suppression and endocrine therapy is better than endocrine therapy and ovarian supression alone.
Subjects will be required to keep all study appointments, take the medications as required, have an annual mammogram, inform the study of any over the counter medications they may be taking.
Patients must be premenopausal
The patient must have an ECOG performance status of ≤ 2
Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
pT4 tumors, including inflammatory breast cancer.
History of ipsilateral or contralateral invasive breast cancer.
Life expectancy of < 10 years due to co-morbid conditions in the opinion of the investigator.
PSCI 23-121 Phase III Randomized Trial of Stereotactic ablativeradiotherapy (SAbR) for Oligometastatic Advanced RenalCarcinoma (SOAR)
This study is looking at patients with oligometastasis comparing chemotherapy and SABR with chemotherapy alone
•Blood counts and blood chemistry done at initiation and every three months to make sure you are not having any side effects from the study affecting your blood counts.•CT or MRI scans done at initiation and every three months to monitor the response of the treatment to your cancer•Physical exams done every three months to confirm your general well-being and to detect side effects from the study.Compete physical and well being form as set below:•Baseline•3 months from start of treatment•6 months from start of treatment•9 months from start of treatment•12 months from start of treatment•18 months from start of treatment•24 months from start of treatment
patient may not have brain metastases
Patient may have any RCC histology except a histology that has a sarcomatoid component.
Patient must have a pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma (RCC) prior to randomization.
Patient must have primary site addressed by local therapy. If the primary RCC is intact, the patient must undergo local treatment to the primary before randomization.
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
Patients must not expect to conceive until after 6 months after the last dose of protocol medication
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.
In order to participate in the QOL portion of the protocol, the patient must speak English or Spanish.
PSCI 23-144 NRG-LU008: PHASE III PROSPECTIVE RANDOMIZED TRIAL OF PRIMARY LUNG TUMOR STEREOTACTIC BODY RADIATION THERAPYFOLLOWED BY CONCURRENT MEDIASTINAL CHEMORADIATION FOR LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER
Patients diagnosed withy inoperable node positive non small cell lung cancer will be randomized to with radiation therapy to all know sites of disease in the lung, followed by immunotherapy or radiation to the primary lung tumor, followed by radiation to the lymph nodes followed by immunotherapy
Participants will be required to come to all study visits, report to the study doctor any new medications, prescription or over the counter that they may be taking,
The patient must be deemed clinically appropriate for curative intent definitive combined modality therapy, based on the following staging assessments:
No evidence of distant metastases based on FDG PET/CT scan obtainedwithin 60 days of registration.
Primary tumor ≤ 7 cm;
Age ≥ 18;
Patients without identifiable primary tumor
Centrally located primary tumor < 2 cm from involved nodal disease which would result in significant overlap of the primary SBRT and nodal radiation fields
Participants who are pregnant or unwilling to discontinue nursing.
Participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) unwilling to use highly effective contraceptives during therapy