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Endometrial Neoplasms clinical trials

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NCT ID: NCT01610375 Completed - Endometrial Cancer Clinical Trials

Telephone Follow-up After Treatment for Endometrial Cancer

TEACUP
Start date: June 2012
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the feasibility, safety and accuracy of a telephone follow-up for women previously treatment for endometrial cancer. To achieve this aim, potentially eligible women attending the Queensland Centre for Gynaecological Cancer (QCGC) outpatient clinic for review following previous treatment for endometrial cancer will be recruited by this study. The study aims to recruit all new patients as well as all patients who return to QCGC for their follow-up and who had treatment within the previous 2 years. The proposed project will involve generation of an evidence-based checklist of signs and symptoms of disease recurrence from a thorough literature review. The generated symptom checklist will be pilot tested and the refined symptom checklist will be used to follow study participants over a period of 12 months. During the follow-up period, the basic standard of follow-up after primary treatment for endometrial cancer at the QCGC, Royal Brisbane and Women's Hospital (RBWH)will not be altered; however, the study participants will be interview via telephone 2 to 5 days prior to their scheduled review dates. The main outcome measure will be the estimated recurrence rate as derived from the telephone assessment and this will be compared to the clinically detected recurrences as recorded in patients' medical files. It is hypothesized, that the telephone follow-up will identify 90% of all recurrences correctly that are later confirmed during the clinical follow-up. In addition to the main outcome, we will also assess patients' satisfaction with each of the follow-up programs, whether or not lifestyle behaviours were queried and support offered to improve wellbeing.

NCT ID: NCT01588522 Completed - Breast Cancer Clinical Trials

Compound 31543 (Calcitriol, USP) in Patients Receiving Taxane-based Chemotherapy Regimens for Advanced or Recurrent Disease

Start date: July 2012
Phase: Phase 1
Study type: Interventional

This will be a dose escalation study to determine the maximum tolerated dose (MTD) and the overall safety and tolerability of a topical compound 31543 (Calcitriol) in patients with metastatic or recurrent cancer who are undergoing chemotherapy with a taxane-based regimen.

NCT ID: NCT01582906 Completed - Ovarian Cancer Clinical Trials

A Survivorship Care Plan for Gynaecological Cancer Patients

Start date: August 2011
Phase: N/A
Study type: Observational

After treatment women surviving gynaecological cancer may experience lateeffects and longterm challenges specific to their disease and treatment resulting in functional deficits and a reduction in societal integration (Yabroff et al., 2004, Yadav, 2007). The available research on best models of posttreatment rehabilitation support for women posttreatment for gynaecological cancer is limited. The primary objective of this study is to determine if there is any additional benefit, over usual rehabilitation care, of additional rehabilitation appointments to develop a survivorship care plan on cancer specific health related quality of life. Secondary objectives are to determine any additional benefit to general selfefficacy, generic health related quality of life or social and health economics for patients who have completed treatment for stage I or II gynaecological cancer. Also to explore the patient's perspectives of the intervention. The study will be open to patients attending the outpatient gynaecological clinics of the Royal Marsden NHS Foundation Trust having recently completed treatment for Stage I or II gynaecological cancer. They will report that they have experienced a physical or psychosocial need resulting from the disease or its treatment; be aged over 18 years and be willing and able to articulate their needs. The study will last for six months for each participant. It will involve completing questionnaires and attending two extra rehabilitation appointments to develop a survivorship care plan at the hospital may also include attending for an interview about being involved in the study for those randomised to the intervention group

NCT ID: NCT01580696 Completed - Ovarian Cancer Clinical Trials

Phase I/IIa Trial of Folate Binding Protein Vaccine in Ovarian Cancer

Start date: April 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is the source of immunogenic peptides (E39) that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy FBP-expressing cancer cells in the laboratory. The purpose of this study is to test whether a peptide-based vaccine consisting of the E39 peptide mixed with the FDA-approved immunoadjuvant granulocyte macrophage colony-stimulating factor (GM-CSF) is safe and effective at inducing an in vivo peptide-specific immune response. Furthermore, the investigators intend to determine the best dose of the vaccine to utilize to produce this immunity most efficiently. The investigators will determine whether immunity to FBP will prevent clinical recurrence. Additionally, the investigators will compare these results with results from a trial utilizing the E75 peptide (from the HER2/neu protein) in ovarian and endometrial cancer patients in preparation for studying a combination vaccine.

NCT ID: NCT01562106 Completed - Endometrial Cancer Clinical Trials

Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery

Start date: February 2012
Phase: N/A
Study type: Interventional

The main purpose of the study is to evaluate the detection rate and accuracy of fluorescence imaging in endometrial cancer staging by sentinel node assessment.

NCT ID: NCT01549782 Completed - Microbiota Clinical Trials

Mixture of Prebiotics on Intestinal Microbiota of Patients Receiving Abdominal Radiotherapy.

Start date: June 2005
Phase: N/A
Study type: Interventional

Abdominal and pelvic radiotherapy (RT) reduces the renewal capacity of the epithelium. Rectal biopsies obtained from patients receiving pelvic RT have revealed atrophy of surface epithelium, acute cryptitis, crypt abscesses, crypt distortion and atrophy, and stromal inflammation. Modifications in intestinal microbiota, such as an increase in the number of pathogens, may contribute to intestinal injury. The prebiotic effect of a carbohydrate is assessed by its capacity to stimulate the proliferation of healthy bacteria (Bifidobacterium, Lactobacillus) rather than pathogenic bacteria (Clostridium, E. coli). The hypothesis of the study is that a mixture of inulin and fructooligosaccharide could modulate Lactobacillus and Bifidobacterium and reduce the intestinal injury in patients affected of gynaecological cancer and treated with abdominal radiotherapy.

NCT ID: NCT01527396 Completed - Endometrial Cancer Clinical Trials

Prospective, Observational Study of Low-risk Criteria for Node Metastasis in Endometrial Cancer

PALME
Start date: December 2011
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the efficacy of low risk criteria for lymph node metastasis, that was determined by KGOG-2014 retrospective study, in women with endometrial cancer.

NCT ID: NCT01526655 Completed - Endometrial Cancer Clinical Trials

Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

Start date: January 25, 2012
Phase: N/A
Study type: Interventional

The purpose of the trial is to determine whether robot assisted laparoscopic hysterectomy compared with abdominal hysterectomy in a fast track program gives a faster recovery postoperatively, causes less tissue damage and less effects on the immunological system, and is health economically cost-effective.

NCT ID: NCT01523678 Completed - Ovarian Cancer Clinical Trials

Weekly Paclitaxel/Carboplatin With Neupogen in Gynaecological Cancers

Start date: February 2012
Phase: Phase 2
Study type: Interventional

Rationale: The administration of prophylactic G-CSF may reduce the toxicity of a weekly paclitaxel/carboplatin regimen in gynaecological cancers. Purpose: This multicenter phase II trial is studying the side effects of weekly paclitaxel/carboplatin when given with prophylactic G-SCF in patients with recurrent epithelial ovarian-, primary peritoneal or fallopian tube cancers, endometrial carcinoma or cervical carcinoma. Data obtained in this trial will be compared with historical data as published earlier. The trial will include 3 cohorts of 36 patients: - Subjects with ovarian, fallopian tube or peritoneal carcinoma - Subjects with endometrial cancer - Subjects with cervical carcinoma Treatment: Subjects will receive Paclitaxel 60 mg/m² followed by Carboplatin AUC 2.7 intravenously weekly during 18 weeks. Filgrastim (Neupogen) will be given to all patients on day 5 and possibly on day 6 of each course. Subjects will be evaluated by CT/MRI scan after 9 cycles of chemotherapy (week 10), after 18 cycles of chemotherapy, then every 6 months for the next 2 years and then if clinically indicated. Subjects who develop disease progression will discontinue therapy. Subjects who have no evidence of disease progression after completion of study therapy will be followed until disease progression, withdrawal of informed consent, or death.

NCT ID: NCT01512810 Completed - Endometrial Cancer Clinical Trials

Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer

Start date: January 2012
Phase: Phase 2
Study type: Interventional

Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy.