Postoperative Adjuvant Chemotherapy With Bevacizumab and Maintenance Bevacizumab After Neoadjuvan… (NCT02022917) | Clinical Trial Compass
CompletedPhase 2
Postoperative Adjuvant Chemotherapy With Bevacizumab and Maintenance Bevacizumab After Neoadjuvant Chemotherapy for Ovarian Cancer
Taiwan22 participantsStarted 2014-03
Plain-language summary
This study is to determine the feasibility of postoperative platinum-based chemotherapy plus adjuvant and maintenance bevacizumab after neoadjuvant chemotherapy followed by interval surgery in patients with extensive stage IIIC or IV ovarian, tubal, and peritoneal cancer.
Who can participate
Age range20 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. previously untreated histologically proven epithelial ovarian cancer, tubal or peritoneal primary carcinoma, of FIGO stage IV or extensive stage III deem not feasible for primary cytoreductive surgery
✓. well informed about the rationale of neoadjuvant chemotherapy as an alternative to upfront surgery followed by adjuvant chemotherapy and accepted treatment with three to four cycles of neoadjuvant treatment with three to four cycles of platinum-based regimen without progression followed by interval cytoreductive surgery
✓. performance status of ECOG 0-2
✓. adequate hematopoietic function is defined as below:
✕. borderline ovarian tumors, recurrent epithelial ovarian, tubal or peritoneal or non-epithelial cancers
✕. history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarrachnoid hemorrhage within six months of the first date of treatment on this study.
What they're measuring
1
Significant event rate of the regimen (neoadjuvant carboplatin, paclitaxel, and bevacizumab)
✕. Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded.
✕. other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
✕. patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their ovarian, peritoneal primary or fallopian tube carcinoma
✕. patients with serious, non-healing wound, ulcer, or bone fracture.
✕. patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations.
✕. history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months.