EUCTR2011-001015-32-DE
Active, not recruiting
Phase 1
A prospective randomised Phase III trial to evaluate optimal treatment duration of first-line bevacizumab in combination with carboplatin and paclitaxel in patients with primary epithelial ovarian, fallopian tube or peritoneal cancer. - The BOOST (Bevacizumab Ovarian Optimal Standard Treatment) Trial
ConditionsFollowing primary cytoreductive surgery, patients with newly diagnosed FIGO stage IIB - IV (all grades and all histological types) epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinomas with indication for a platin/paclitaxel chemotherapyMedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsAvastin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Following primary cytoreductive surgery, patients with newly diagnosed FIGO stage IIB - IV (all grades and all histological types) epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinomas with indication for a platin/paclitaxel chemotherapy
- Sponsor
- AGO Research GmbH
- Enrollment
- 900
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Written informed consent and patients awareness
- •and willingness to comply with the study
- •requirements
- •\- Primary diagnosis is confirmed by specialized
- •pathology review (Germany only)
- •\- Age \= 18 years
- •\- Histologically confirmed, newly diagnosed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma and FIGO stage IIB \- IV (all grades and all histological types)
- •\- Patients should have already undergone surgical debulking and no planned surgical debulking prior to disease progression. Patients
- •with stage III and IV disease in whom initial surgical debulking was not
- •appropriate or possible are eligible providing other criteria are fulfilled
Exclusion Criteria
- •\- Non\-epithelial origin of the ovary, the fallopian
- •tube or the peritoneum
- •\- Borderline tumours and FIGO stage IA – IIA
- •\- Planned intraperitoneal cytotoxic chemotherapy
- •\- Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab or anticipation of interval cytoreductive surgery during study treatment
- •\- Uncontrolled hypertension
- •\- Any previous radiotherapy to the abdomen or pelvis
- •\- Previous Cerebro\-Vascular Accident, Transient Ischaemic Attack or Sub\-Arachnoid Haemorrhage within 6 months prior to randomisation
- •\- Malignancies other than ovarian cancer within 5 years prior to randomisation, except for adequately treated carcinoma in situ of the cervix and/or basal cell skin cancer and/or non\-melanomatous skin cancer, carcinoma in situ of the breast and/or early endometrial carcinoma
- •\- Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless the given single criterion is met
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Evaluation of optimal initial treatment duration of bevacizumab in combination with carboplatin and paclitaxel in patients with ovarian cancer.Following primary cytoreductive surgery, patients with newly diagnosed FIGO stage IIB - IV (all grades and all histological types) epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinomas with indication for a platin/paclitaxel chemotherapyMedDRA version: 14.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2011-001015-32-FRAGO Research GmbH796
Active, not recruiting
Phase 1
Evaluation of optimal initial treatment duration of bevacizumab in combination with carboplatin and paclitaxel in patients with ovarian cancer.Following primary cytoreductive surgery, patients with newly diagnosed FIGO stage IIB - IV (all grades and all histological types) epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinomas with indication for a platin/paclitaxel chemotherapyMedDRA version: 19.1Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2011-001015-32-DKAGO Research GmbH796
Active, not recruiting
Phase 1
The BOOST (Bevacizumab Ovarian Optimal Standard Treatment) TrialEpithelial ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma, FIGO Stages IIb-IVMedDRA version: 14.1Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2011-001015-32-FIJohanna Mäenpää796
Recruiting
Phase 3
A randomised phase III trial evaluating the efficacy of more intensive written information in patients having radical radiation therapy.Anxiety levelsPatient satisfaction.Mental Health - AnxietyACTRN12605000705684Perth Radiation Oncology Centre212
Active, not recruiting
Not Applicable
A Phase III randomised, controlled trial of exercise during chemotherapy for patients commencing first line treatment for ovarian cancerOvarian CancerCancer - Ovarian and primary peritonealACTRN12614001311640niversity of Sydney524