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Visit 14 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 14

- 17/2/16 - 1 formulario, 5 itemgroups, 48 items, 1 idioma
Itemgroups: Visit 14: Sixth cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 13 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 13

- 17/2/16 - 1 formulario, 5 itemgroups, 48 items, 1 idioma
Itemgroups: Visit 13: Fifth cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 11 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 11

- 17/2/16 - 1 formulario, 5 itemgroups, 48 items, 1 idioma
Itemgroups: Visit 11: Third cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 10 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 10

- 16/2/16 - 1 formulario, 5 itemgroups, 48 items, 1 idioma
Itemgroups: Visit 10: Second cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 9 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 9

- 16/2/16 - 1 formulario, 5 itemgroups, 48 items, 1 idioma
Itemgroups: Visit 9: First cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Prenext Course Visit

- 8/7/19 - 1 formulario, 8 itemgroups, 26 items, 1 idioma
Itemgroups: Administrative documentation, Topotecan, Chemotherapy Regimen, Serious Adverse Event, Vital Signs, 12 lead ECG, Topotecan, Chemotherapy Regimen, Topotecan, Chometherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Prenext Course Visit

- 8/7/19 - 1 formulario, 11 itemgroups, 38 items, 1 idioma
Itemgroups: Administrative documentation, Topotecan, Chemotherapy Regimen, Serious Adverse Event, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Vital Signs, 12 lead ECG, Topotecan, Chemotherapy Regimen, Topotecan, Chometherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Study Medication 5 Days On, 2 Days Off for 3 Weeks Regimen

- 5/7/19 - 1 formulario, 6 itemgroups, 21 items, 1 idioma
Itemgroups: Administrative documentation, Body Weight, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Dose Reduced
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Study Medication 5 Days On, 2 Days Off for 3 Weeks Regimen

- 5/7/19 - 1 formulario, 5 itemgroups, 18 items, 1 idioma
Itemgroups: Administrative documentation, Body Weight, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen, Topotecan, Chemotherapy Regimen
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Oral Topotecan Daily X5 Days Regimen

- 5/7/19 - 1 formulario, 3 itemgroups, 11 items, 1 idioma
Itemgroups: Administrative documentation, Body Weight, Body Surface Area, Topotecan, Chemotherapy Regimen
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502 - Study Medication Daily X5 Days Regimen

- 5/7/19 - 1 formulario, 3 itemgroups, 14 items, 1 idioma
Itemgroups: Administrative documentation, Body Weight, Body Surface Area, Topotecan, Chemotherapy Regimen
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Predictors of Therapeutic Response in Ovarian Carcinoma NCT01391351 - Eligibility Criteria

- 23/6/19 - 1 formulario, 2 itemgroups, 13 items, 1 idioma
Itemgroups: Inclusion Criteria, Exclusion Criteria
Search for Predictors of Therapeutic Response in Ovarian Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01391351 In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be studied during the first course in response to chemotherapy. Indeed, the miRNA profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months).

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