Search results for " protocol"
showing 10 items of 1320 documents
Phase 2 Trial of Docetaxel, Gemcitabine, and Oxaliplatin Combination Chemotherapy in Platinum- and Paclitaxel-Pretreated Epithelial Ovarian Cancer
2009
Background: This phase 2 trial was designed to evaluate the efficacy and toxicity of a combination of docetaxel, gemcitabine, and oxaliplatin for platinum- and paclitaxel-pretreated epithelial ovarian cancer. Patients and Methods: Heavily pretreated patients (N = 30; median age, 61 years) received docetaxel, 55 mg/m2; gemcitabine, 500 mg/m2 (day 1); and oxaliplatin, 70 mg/m2 (day 2) biweekly. Twelve patients had platinum-sensitive disease, and 18 patients had platinum-resistant disease. Results: Median follow-up was 18.6 months. No differences in patient characteristics were observed between patients with carboplatinum-sensitive and carboplatinum-resistant disease. In patients with carbopla…
A multicenter phase III prospective randomized trial of high-dose epirubicin in combination with cyclophosphamide (EC) versus docetaxel followed by E…
2011
Background: The Gruppo Oncologico Italia Meridionale 9902 trial compared four cycles of high-dose epirubicin plus cyclophosphamide (EC) with four cycles of docetaxel (Taxotere, D) followed by four cycles of EC as adjuvant treatment of node-positive breast cancer. Patients and methods: Patients were randomly assigned to EC (E 120 mg/m 2 , C 600 mg/m 2 , arm A) for four cycles or four cycles of D (100 mg/m 2 ) followed by four cycles of EC (arm B), both regimens every 21 days. Hormone receptor-positive patients were given hormonal therapy for 5 years. Primary end point was 5-year disease-free survival (DFS). Secondary objectives were overall survival (OS) and safety. Results: There were 750 p…
Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study
2019
Abstract Metronomic chemotherapy (mCHT) refers to the minimum biologically effective dose of a chemotherapy agent given as a continuous dosing regimen, with no prolonged drug-free breaks, that leads to antitumor activity. Aim of the present study is to describe the use of mCHT in a retrospective cohort of metastatic breast cancer (MBC) patients in order to collect data regarding the different types and regimens of drugs employed, their efficacy and safety. Between January 2011 and December 2016, data of 584 metastatic breast cancer patients treated with mCHT were collected. The use of VRL-based regimens increased during the time of observation (2011: 16.8% - 2016: 29.8%), as well as CTX-bas…
Combination therapy with pegylated liposomal doxorubicin and carboplatin in gynecologic malignancies: A prospective phase II study of the Arbeitsgeme…
2007
Abstract Objective. A multicenter non-randomized phase II study was initiated to evaluate tolerability and efficacy of pegylated liposomal doxorubicin (PLD) in combination with carboplatin in gynecologic malignancies. Methods. One hundred forty women with recurrent or advanced endometrial ( n =31), cervical or vaginal cancer ( n =31), uterine sarcomas ( n =11), or recurrent platinum-sensitive ovarian cancer ( n =67) received six courses of PLD 40 mg/m 2 and carboplatin (AUC 6) every 28 days. Results. Hematological toxicities with NCI-CTC grade 3/4 were anemia in 8%, thrombocytopenia in 14%, neutropenia in 24%, and febrile neutropenia in 2% of 652 cycles. Grade 3/4 non-hematological toxiciti…
Phase II trial of docetaxel and carboplatin in recurrent platinum-sensitive ovarian, peritoneal and tubal cancer
2007
Abstract Objective. Docetaxel and carboplatin are active in relapsed ovarian, peritoneal and tubal cancer. Recently, two prospective-randomized trials showed an advantage of carboplatin combination regimen with paclitaxel or gemcitabine over carboplatinum alone in platinum-sensitive cases. The question on the most effective combination with the best tolerable side effects still needs to be answered. Methods. Eligible patients had recurrent ovarian, peritoneal or tubal cancer (platinum-free interval >6 months), performance status 0–2 and normal bone marrow, renal and hepatic function. 25 patients (age 18–75 years) were enrolled into this phase II trial. Patients with debulking operation of r…
Outcome of peripheral blood stem cell mobilization in advanced phases of CML is dependent on the type of chemotherapy applied
1998
High-dose chemotherapy with autologous transplantation of in vivo purged PBSC is a novel investigational approach to treating chronic myelogenous leukemia (CML) patients not responsive to conventional therapy with interferon-alpha (IFN-alpha) and not eligible for allogeneic transplantation. PBSC mobilization using either '5+2/7+3'-type chemotherapy or 'mini-ICE/ ICE' chemotherapy was investigated in 43 patients with advanced phases of Philadelphia (Ph)-positive CML. Thirty patients were in late chronic phase (12 months post diagnosis) and 13 patients in accelerated phase (AP) or blast crisis (BC). Contamination with Ph-positive cells was evaluated in harvests from 37/43 patients. The outcom…
Study protocol: fit for delivery - can a lifestyle intervention in pregnancy result in measurable health benefits for mothers and newborns? A randomi…
2013
Abstract Background The global obesity epidemic has led to increased attention on pregnancy, a period when women are at risk of gaining excessive weight. Excessive gestational weight gain is associated with numerous complications, for both mother and child. Though the problem is widespread, few studies have examined the effect of a lifestyle intervention in pregnancy designed to limit maternal weight gain. The Fit for Delivery study will explore the effectiveness of nutritional counseling coupled with exercise classes compared with standard prenatal care. The aims of the study are to examine the effect of the intervention on maternal weight gain, newborn birth weight, glucose regulation, co…
Whole-body MRI radiomics model to predict relapsed/refractory Hodgkin Lymphoma: A preliminary study.
2022
Purpose A strong prognostic score that enables a stratification of newly diagnosed Hodgkin Lymphoma (HL) to identify patients at high risk of refractory/relapsed disease is still needed. Our aim was to investigate the potential value of a radiomics analysis pipeline from whole-body MRI (WB-MRI) exams for clinical outcome prediction in patients with Hodgkin Lymphoma (HL). Materials and methods Index lesions from baseline WB-MRIs of 40 patients (22 females; mean age 31.7 ± 11.4 years) with newly diagnosed HL treated by ABVD chemotherapy regimen were manually segmented on T1-weighted, STIR, and DWI images for texture analysis feature extraction. A machine learning approach based on the Extra T…
The randomized shortened dental arch study (RaSDA): design and protocol
2010
Abstract Background Various treatment options for the prosthetic treatment of jaws where all molars are lost are under discussion. Besides the placement of implants, two main treatment types can be distinguished: replacement of the missing molars with removable dental prostheses and non-replacement of the molars, i.e. preservation of the shortened dental arch. Evidence is lacking regarding the long-term outcome and the clinical performance of these approaches. High treatment costs and the long time required for the treatment impede respective clinical trials. Methods/design This 14-center randomized controlled investigator-initiated trial is ongoing. Last patient out will be in 2010. Patien…
Long-term outcome of treatment with dacarbazine, cisplatin, interferon-α and intravenous high dose interleukin-2 in poor risk melanoma patients
1998
Melanoma patients with very advanced disease are usually excluded from chemoimmunotherapy trials; however, the efficacy of intensive treatment regimens needs to be established for this patient population. This study aimed to evaluate the response rate and survival achieved with chemoimmunotherapy in very advanced melanoma patients. Forty-two patients received dacarbazine (250 mg/m2, days 1-3), cisplatin (30mg/m2, days 1-3), interferon-alpha (10 Mio IU/m2 subcutaneously, days 1-5) and intravenous interleukin-2 (18 Mio IU/m2 over 6 h, 12 h then 24 h, followed by 13.5 MioIU/m2 in 72 h). In cases of brain metastases (n = 12) radiation therapy was added. Ten patients (24%) achieved a partial res…