An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without Bevacizumab in Platinum-resistant ovarian cancer patients previously treated with Bevacizumab for front-line or Platinum-sensitive ovarian cancer: -JGOG3023 trial-

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2015
INTERVENTION: chemotherapy + Bevacizumab chemotherapy alone CONDITION: Patients who have platinum‐resistant disease (defined as progression within <6 months from completion of prior chemotherapy therapy including Bevacizumab for histologically confirmed epithelial ovarian or fallopian tube carcinoma or primary peritoneal carcinoma). PRIMARY OUTCOME: Progression‐free survival:PFS SECONDARY OUTCOME: Overall survival: OS; Objective Response Rate: ORR; Safety; Number of paracentesis; Tumor marker (CA125) response rate" INCLUSION CRITERIA: 1.Patients histologocally confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. 2.Patients must have platinum‐resistant disease (defined as progression within <6 months from completion of a minimum of 3 platinum therapy (including Bevacizumab) cycles. (Assessment for disease progression by tumor marker alone is not accepted.) 3.Patients >= 20 years of age. 4.ECOG Performance Status: 0‐2 5.Patients can be included if they have a RECIST progression, with either measurable or non‐measurable disease. Patient who can be evaluated based on GCIG CA125 criteria is allowed 6.Life expectancy of >= 90 days. 7.Signed informed consent obtained prior to initiation of any study‐specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements. 8.Adequate following organ function. a.Neutrophils count >= 1,500 /mm3 b.Platelet count >= 10.0x1
Epistemonikos ID: e89c4e38f01eccfdd1c82bbfac8dd26afa235e63
First added on: Aug 23, 2024