Upfront Treatment With Chemotherapy and Bevacizumab in Advanced Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03611179|
Recruitment Status : Not yet recruiting
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Ovarian Cancer||Drug: Bevacizumab||Phase 2|
Ovarian cancer is the most lethal gynecologic malignancy and is the fifth most common cause of cancer death in women .The majority of women with ovarian cancer are diagnosed with advanced-stage disease; only 15% of all cases are diagnosed with local disease. Risk factors for ovarian cancer include family history, nulliparity, lack of breast feeding, and infertility .
The GOG-0218 trial demonstrated that the use of bevacizumab in the front-line and maintenance setting improved progression free survival by 3.8 months when compared with conventional every-3-weeks carboplatin and paclitaxel.
The ICON-7 trial also aimed to compare the progression free survival and Overall survival in women who receive bevacizumab with carboplatin/paclitaxel and women receiving carboplatin/paclitaxel alone The final results of ICON7 were announced in 2013. Overall, the results showed no difference in overall survival between those in the group receiving bevacizumab han those in the group receiving no bevacizumab. However, for high-risk patients, who were most likely to have early disease progression, the results were positive and showed an improvement in overall survival of 4.8 months in the group who received bevacizumab.
Not only has the best route been intensely debated but the optimal timing of therapy has been and is currently being studied. Chemotherapy is usually given either only after primary debulking surgery or as both neoadjuvant chemotherapy before and after interval debulking surgery. recent trials have tried to determine which treatment timing is associated with better outcomes .
The aim of the study will be assessment of response, survival and toxicity of frontline treatment with chemotherapy and Bevacizumab in patients having advanced epithelial ovarian cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||40 patients diagnosed with advanced epithelial ovarian cancer presenting to Assiut university hospitals ,,the aim of the study is evaluation of response, survival and toxicity of upfront chemotherapy with Bevacizumab in those patients.|
|Masking:||None (Open Label)|
|Official Title:||Upfront Treatment With Chemotherapy and Bevacizumab in Advanced Ovarian Cancer|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||September 1, 2022|
Experimental: advanced ovarian cancer cases
patients with advanced ovarian cancer will receive Bevacizumab 15 mg/kg every 21 days with chemotherapy (Paclitaxel 175 mg/m2 & Carboplatin AUC 5 every 21 days)
The chemotherapy regimen will be Paclitaxel (175 mg/m2 of body surface area) administered intravenously over 3 h, followed by carboplatin (area under the curve 5) over 1 h, with standard antiemetic and hypersensitivity medications.
In patients who develop dose-limiting peripheral neuropathy or hypersensitivity, paclitaxel will be replaced with docetaxel (75 mg/m2), which is administered intravenously over 1 h.
Bevacizumab (15 mg/kg bodyweight) administered intravenously initially over 90 min (if tolerated, this time can be reduced to 60 min, and could be further reduced to a minimum of 30 min)
Other Name: Chemotherapy drugs
- progression free survival [ Time Frame: 2 years ]determination of time from starting treatment until first progression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611179
|Contact: nada H salah, ass.lect||01090779001 ext +email@example.com|
|Contact: ola N abdel fattah, ass.prof||01023080090 ext +firstname.lastname@example.org|
|Study Director:||mohammed A mekkawy, prof||Assiut University|
|Study Director:||mohammed A hassan, lecturer||Assiut University|
|Study Director:||hisham abo taleb, lecturer||Assiut University|