Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Carboplatin and paclitaxel on day 1 of a 21-day cycle for 6 cycles

Carboplatin on day 1 and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles

Dose-fractionated weekly carboplatin and weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles.

AUC5 by intravenous infusion over 30-60 minutes

AUC2 by intravenous infusion over 30-60 minutes

175mg/m2 by intravenous infusion over 3 hours

80mg/m2 by intravenous infusion over 1 hour

Monique Tomiczek

Laura Farrelly

The purpose of this study is to determine if weekly chemotherapy (i.e. giving paclitaxel or carboplatin at a lower dose every week) is more effective than standard chemotherapy (paclitaxel and carboplatin given once every three weeks over 18 weeks) in treating ovarian cancer. The investigators also want to see if weekly chemotherapy causes more or fewer side-effects than standard chemotherapy.

ICON8 is a three-arm, three stage trial. Patients will be randomised in a 1:1:1 ratio. Patients in arm 1 (control arm) will receive weekly carboplatin and paclitaxel on day 1 of a 21-day cycle for 6 cycles. Patients in arm 2 will receive carboplatin on day 1 and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles. Patients in arm 3 will receive dose-fractionated weekly carboplatin and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles.

The trial will have three planned stages. Stage 1 will be conducted to confirm feasibility and safety of protocol treatment in all patients and separately in the Delayed Primary Surgery (DPS) patients. The outcome measure for stage 2 will be 9-month progression-free survival (PFS) rate. The primary outcome measures for stage 3 will be PFS and overall survival and secondary outcomes will be toxicity, Quality of Life and Health Economics. If pre-defined levels of deliverability, at stage 1, or activity, at stage 2, are not met then the research arms will be reconsidered.

ICON8: Weekly Chemotherapy in Ovarian Cancer

An International Phase III Randomised Trial of Dose Fractionated Chemotherapy Compared to Standard Three Weekly Chemotherapy, Following Immediate Primary Surgery or as Part of Delayed Primary Surgery, for Women With Newly Diagnosed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Assessment of toxicity profile of dose-fractionated chemotherapy

Assessment of potential impact of dose-fractionated chemotherapy on functionality and well-being in patients undergoing first line treatment for ovarian cancer.

Cost-effectiveness analysis of dose-fractionated chemotherapy

Cancer Research UK

Medical Research Council

Coagulants

Pharmaceutical Solutions

Micronutrients

Hematinics

Tranexamic Acid

Iron

Ferric Compounds

Antifibrinolytic Agents

Hemostatics

ferric carboxymaltose 20 mg/kg (with a maximum dose of 1000 mg ferric carboxymaltose in a single Infusion) (Ferinject® 1000 mg/20 ml) will be administered between day -27 and day -7.

tranexamic acid 10mg/kg (Tranexam OrPha 1000 mg/10 ml, OrPha Swiss GmbH, Küsnacht, Switzerland) will be administered 15 -30 minutes prior to surgery followed by infusion of tranexamic acid through syringe pump (1 mg/kg/h) till 4 h postoperatively

ferric carboxymaltose (Ferinject® 1000 mg/20 ml) between day -27 and day

-7 and tranexamic acid (Tranexam OrPha 1000 mg/10 ml) 15-30 minutes prior to surgery followed by Infusion of tranexamic acid through syringe pump (1 mg/kg/h) till 4 h postoperatively will be administered.

no treatment accordingly "current standard of care" will be given

Ferric carboxymaltose 20 mg/kg (with a maximum dose of 1000 mg ferric carboxymaltose in a single Infusion) (Ferinject® 1000 mg/20ml, Vifor (International) AG, St. Gallen, Switzerland) will be diluted in 250 ml of 0.9% m/V sodium chloride solution and administered over 15 minutes intravenously between day -27 and day -7. The colour of ferric carboxymaltose is dark brown. A single Ferinject administration should not exceed 20 mg iron/kg body weight.

ferric carboxymaltose

Tranexamic acid 10mg/kg (Tranexam OrPha 1000 mg/10 ml, OrPha Swiss GmbH, Küsnacht, Switzerland) will be administered 15 -30 minutes prior to surgery followed by infusion of tranexamic acid through syringe pump (1 mg/kg/h) till 4 h postoperatively. The colour of the medicament is transparent.

tranexamic acid

Ferric carboxymaltose (Ferinject® 1000 mg/20 ml) will be administered between day -27 and day -7 and tranexamic acid (Tranexam OrPha 1000 mg/10 ml) 15-30 minutes prior to surgery followed by infusion of tranexamic acid through syringe pump (1 mg/kg/h) till 4 h postoperatively.

ferric carboxymaltose and tranexamic acid

Gabriela Amstad Bencaiova, Dr. med.

Viola Heinzelmann, Prof. Dr. med.

This study is to determine the effect of perioperative treatment with intravenous iron and tranexamic acid on the reduction of intraoperative and postoperative RBC transfusions in gynaecological carcinoma patients undergoing abdominal surgery.

Radical abdominal surgery often leads to intraoperative bleeding frequently exceeding 1000 ml and approximately 50% of women undergoing this surgery require blood transfusion. Perioperative blood transfusions have been shown to increase of length of stay, surgical complications, postoperative morbidity and mortality. There are a few data on the reduction in red blood cell count (RBC) transfusions using perioperative management with intravenous iron and tranexamic acid in women with gynaecological carcinoma surgery. This study is to determine the effect of perioperative treatment with intravenous iron and tranexamic acid on the reduction of intraoperative and postoperative RBC transfusions in gynaecological carcinoma patients undergoing abdominal surgery.

The study will be blinded to participants and statistician conducting the data analysis. The physicians and nurses who will perform this infusion will not be blinded.

Perioperative Management in Gynaecological Carcinoma Surgery

Perioperative Management With Ferric Carboxymaltose and Tranexamic Acid to Reduce Transfusion Rate in Gynaecological Carcinoma Surgery: a Single-blind, Mono-centre, Randomized Trial

The data generated by our research will be available as soon as possible, wherever legally and ethically possible. The data will be made available upon reasonable request. The deidentified participant data from this study and related documents (study protocol, statistical analysis plan, patient consent form) will be made available upon request. Researchers may request data to repeat the analyses or use the data for secondary analyses (e. g., systematic review and meta-analysis). Changes to this plan will be noted in the Data Availability Statement and updated in the registry record (to comply with ICMJE recommendations).

number of all perioperative (intraoperative and postoperative) administered RBC transfusions (the absolute rate of RBC transfusions)

rate of transfused women with gynaecological carcinoma during and/or after surgery

rate of other blood product transfusions (fresh frozen plasma, autologous whole blood)

requirement of additional local or systematic haemostatic therapy (descriptive)

number of postoperative complications: abdominal pain, haemorrhage, reoperation owing to bleeding, wound infection, pulmonary complications, postoperative renal dysfunction, systemic sepsis

University Hospital, Basel, Switzerland

Immune System Diseases

Hypersensitivity

Cediranib

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients in this arm will receive standard platinum based chemotherapy plus a daily oral placebo tablet for the duration of chemotherapy and then until protocol defined disease progression occurs.

Patients in this arm will receive standard platinum based chemotherapy plus a daily oral cediranib tablet during chemotherapy only and then an oral daily placebo tablet until protocol defined disease progression occurs.

Patients in this arm will receive standard platinum based chemotherapy plus a daily oral cediranib tablet during chemotherapy until protocol defined disease progression occurs.

Once-daily oral tablet starting dose 20mg

cediranib

Jonathan Ledermann, Prof.

The purpose of this study is to assess the safety and efficacy of cediranib in combination with standard chemotherapy, in patients who have relapsed with ovarian, fallopian tube or epithelial cancer, after first line platinum based treatment.

ICON6 is a randomised three-arm, two stage, double-blind, placebo-controlled multicentre Gynaecologic Cancer InterGroup (GCIG) phase III trial.

All patients will receive 6 cycles of platinum-based chemotherapy. Trial drug will be administered for up to 18 months from randomisation or until progression, whichever is sooner. Patients who have not progressed at 18 months from randomisation can continue Trial Drug until progression, if in the opinion of the clinician and the patient there is continuing clinical benefit.

Patients in Arm A (the reference arm) will receive a platinum-based chemotherapy regimen plus a daily oral placebo tablet for the duration of the chemotherapy and up to 18 months from randomisation or until progression.

Patients in Arm B (concurrent cediranib arm) will also receive a platinum-based chemotherapy regimen plus daily oral cediranib during chemotherapy only, and then an oral daily placebo tablet up to 18 months from randomisation or until progression.

Patients in Arm C (concurrent and maintenance cediranib arm) will also receive a platinum-based chemotherapy regimen plus oral cediranib daily during chemotherapy and then continued up to 18 months from randomisation or until progression.

An RCT of Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian Cancer

A Randomised, Placebo-controlled, Trial of Concurrent Cediranib [AZD2171] (With Platinum-based Chemotherapy) and Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ICON8: Weekly Chemotherapy in Ovarian Cancer	NCT01654146	Ovarian Cancer	Carboplatin Carboplatin Paclitaxel Paclitaxel	18 Years -	Medical Research Council
Perioperative Management in Gynaecological Carcinoma Surgery	NCT04625530	Gynaecological ...	ferric carboxym... tranexamic acid ferric carboxym...	18 Years -	University Hospital, Basel, Switzerland
An RCT of Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian Cancer	NCT00532194	Ovarian Cancer	cediranib	18 Years -	Medical Research Council
Perioperative Management in Gynaecological Carcinoma Surgery	NCT04625530	Gynaecological ...	ferric carboxym... tranexamic acid ferric carboxym...	18 Years -	University Hospital, Basel, Switzerland

Spots Global Cancer Trial Database for gynaecological carcinoma