The Potential for Metformin to Improve Tumor Oxygenation in Locally Advanced Cervix Cancer: A Phase...
Uterine Cervical NeoplasmsSquamous Cell Carcinoma3 moreCervical cancer remains an important health problem worldwide. Poor tumor oxygenation (hypoxia) is associated with inferior survival in cervical cancer and resistance to radiation treatment. Hypoxia-modifying therapies improve survival, but existing therapies are impractical and/or toxic. Metformin, a non-toxic drug for diabetes, has been shown to decrease tumor hypoxia in animal studies and its use is associated with better survival in diabetic cancer patients. It is hypothesized that metformin may decrease cervical tumor hypoxia and thereby improve tumor response to radiation and survival in patients with locally advanced cervix cancer. This is a randomized, multicenter phase II study of standard chemoradiation in combination with metformin versus standard chemoradiation alone in women with locally advanced cervix cancer. Women randomized to the metformin group will take metformin starting 1 week prior to standard chemoradiation and throughout the duration of external radiation treatment. Tumor hypoxia will be measured by a special X-ray test called positron emission test (PET) performed with a hypoxia dye called FAZA. The main purpose of this study is to see if metformin decreases tumor hypoxia measured on FAZA-PET; information about response and side effects will also be collected.
Accuracy of Portable Colposcopy and HPV Genotypes Among HIV+ Women
Cervical CancerHuman Papillomavirus1 moreThis study will evaluate the effectiveness of portable colposcopy when compared to conventional colposcopy (25x magnification of the cervix, the gold standard) and Visualization Inspection with Acetic acid (VIA, with 1x magnification, the accepted low-resource method). Half the participants will be evaluated for cervical pathology by portable colposcopy after VIA assessment, while the other half will be evaluated by conventional colposcopy. This study also will use collected lab specimens for human papillomavirus (HPV)-positive women to determine those HPV genotypes most prevalent among higher grade disease cases (CIN II+) and among the sub-group of human immunodeficiency virus (HIV)-positive women.
Hyperthermia Combined Brachytherapy in CCU
Cervical CancerThe aim of this randomised trial was to investigate whether hyperthermia (HT) combined with interstitial brachytherapy (ISBT) has any influence on local control (LC), disease-free survival (DFS), or acute and late side effects in patients with advanced cervical cancer. Vaginal symptoms were assessed by SOMA score, bladder and rectum symptoms by EORTC/RTOG score. Following the completion of radiochemotherapy, consecutive patients with cervical cancer (FIGO stage II - III) were randomly assigned to two treatment groups, either ISBT alone or ISBT combined with interstitial hyperthermia (ISHT). A total of 205 patients were included in the statistical analysis. Once a week, HT, at a temperature above 42.5°C, was administered for 45 minutes before and during the HDR BT. Follow-up examinations were scheduled at 6 weeks after the completion of BT, every 3 months during the first 2 years, and every 6 months throughout the next 3 years. If relapse was suspected, biopsies were obtained from these patients.
MR- PET Guided Biologically Optimised Interstitial Brachytherapy
Cervical CancerThe proposed two stage study will evaluate patterns of local recurrence after EBRT and brachytherapy in spatial reference to baseline functional MRI and FLT/F-Miso PET scan in patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. The first stage of the study will focus on developing MR guided interstitial brachytherapy and validating the concept of high risk gross tumor volume (on the basis of functional imaging features). The second stage thereafter will focus on developing biologically modulated interstitial brachytherapy. In the proposed two staged study the investigators intend to prospectively evaluate and validate concept of HRGTV and develop technique of biologically dose modulated brachytherapy. The demonstration of technical feasibility and clinical safety of biologically modulated image guided radiotherapy in this pilot study for may pave the way for improving local control in patients with postoperative recurrences.
Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally...
Cervical AdenocarcinomaCervical Adenosquamous Carcinoma7 moreThis randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with cervical cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.
LESs Surgical Radicality for EaRly Stage Cervical Cancer
Uterine Cervical NeoplasmsThis study is an open-label, multicenter, randomized, phase II non-inferiority trial (proof of concept study). Its purpose is to evaluate the safety and efficacy of extrafascial hysterectomy plus pelvic-lymph node dissection compared with the standard modified radical hysterectomy in patients with stage IA2-IB1 cervical cancer ≤ 2cm.
Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed...
Cervical CancerLocally Advanced Cervical CancerTo date, the majority of clinical trials on checkpoint inhibitors have tested these agents as monotherapy, and the next logical step is to evaluate rational therapeutic associations. The aim of the NiCOL study is to assess the safety of nivolumab in association with chemoradiation therapy and to gain initial insight into its efficacy in association with the current standard of care, including chemoradiation.
Irreversible Electroporation(IRE) For Uterine Cervical Neoplasms
Uterine Cervical NeoplasmsThe purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Uterine Cervical Neoplasms.
A Trial of Tisotumab Vedotin in Cervical Cancer
Cervical CancerA Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.
Pilot Study of Durvalumab and Vigil in Advanced Women's Cancers
Breast CancerOvarian Cancer5 moreIn this study, the researchers want to learn more about Vigil and durvalumab in advanced women's cancers: 1) how much of Vigil in combination with durvalumab (MEDI4736) can be given with an acceptable level of side effects, 2) the effects of Vigil and durvalumab in combination (good and bad), 3) if Vigil will cause changes in cancer cells that may help durvalumab attack the cancer, and 4) whether or not Vigil and durvalumab will slow your cancer or stop your cancer from getting worse. Combining Vigil with durvalumab will allow the former to induce (or increase) the infiltration of activated T cells into tumors, and in addition, to enhance PD-L1 (programmed cell death ligand 1) expression. Consequently, the response rate of historically low or un-responsive cancer will be increased with the combination of Vigil and anti PD-L1.