Back to resultsSecondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers
Primary Purpose
Ovarian Cancer, Recurrent Ovarian Carcinoma
Status
Withdrawn
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
secondary cytoreductive surgery
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, platinum resistant, cytoreductive surgery, recurrent ovarian cancer, complete resection
Eligibility Criteria
Inclusion Criteria:
- platinum-resistant, recurrent epithelial ovarian cancer
- amenable to complete gross resection, isolated recurrence
- adequate renal, hepatic, and bone marrow function,
- performance-status ECOG score of 0 to 2.
Exclusion Criteria:
- not medically fit for surgery
- diffuse carcinomatosis, ascites, or extra-abdominal disease
Sites / Locations
- Menoufia University, Faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
surgery + chemotherapy
chemotherapy alone
Arm Description
surgical resection for recurrent platinum resistant ovarian cancer followed by second line chemotherapy as per the investigator's choice
second line chemotherapy according to investigator's choice
Outcomes
Primary Outcome Measures
progression free survival (PFS)
the time interval between the first relapse and the second relapse
Secondary Outcome Measures
Overall survival (OS)
the time interval between the date of diagnosis till the date of death
Adverse events (AE)
described according to the CTCAE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04795596
Brief Title
Secondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers
Official Title
Clinical Outcomes of Secondary Cytoreductive Surgery in Platinum-resistant Ovarian Cancers With Isolated Recurrence
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Poor accrual
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 9, 2022 (Actual)
Study Completion Date
April 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This novel study was specifically designed for platinum resistant recurrent ovarian cancers and aimed to compare cases who received secondary cytoreductive surgery for isolated recurrence and chemotherapy versus chemotherapy alone. This comparison will conduct the intraoperative events, postoperative morbidity and mortality, pathological outcomes and long-term oncological outcomes as regarding progression free survival and overall survival rates.
Detailed Description
Baseline postoperative imaging with the use of abdominopelvic CT or MRI was to be completed during a 28-day window in which chemotherapy was initiated. Disease is also assessed after cycles 3 and 6 of trial treatment (and after cycle 8, if administered), every 3 months for 2 years, and then every 6 months thereafter. Physical examinations will be performed, and serum CA-125 levels measured at the beginning of each cycle of chemotherapy. Treatment-free interval (6 to 12 months or >12 months after the last chemotherapy infusion) will be reported.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Recurrent Ovarian Carcinoma
Keywords
ovarian cancer, platinum resistant, cytoreductive surgery, recurrent ovarian cancer, complete resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
patients with platinum resistant cancer ovary will be randomized to one of two arms; either chemotherapy alone or surgical resection followed by chemotherapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgery + chemotherapy
Arm Type
Experimental
Arm Description
surgical resection for recurrent platinum resistant ovarian cancer followed by second line chemotherapy as per the investigator's choice
Arm Title
chemotherapy alone
Arm Type
Active Comparator
Arm Description
second line chemotherapy according to investigator's choice
Intervention Type
Procedure
Intervention Name(s)
secondary cytoreductive surgery
Other Intervention Name(s)
re-resection
Intervention Description
resection of isolated recurrent ovarian carcinoma in platinum resistant disease
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
second line chemotherapy according to investigator's choice
Primary Outcome Measure Information:
Title
progression free survival (PFS)
Description
the time interval between the first relapse and the second relapse
Time Frame
6 months from enrollment
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
the time interval between the date of diagnosis till the date of death
Time Frame
18 months from enrollment
Title
Adverse events (AE)
Description
described according to the CTCAE
Time Frame
6 months from enrollment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
platinum-resistant, recurrent epithelial ovarian cancer
amenable to complete gross resection, isolated recurrence
adequate renal, hepatic, and bone marrow function,
performance-status ECOG score of 0 to 2.
Exclusion Criteria:
not medically fit for surgery
diffuse carcinomatosis, ascites, or extra-abdominal disease
Facility Information:
Facility Name
Menoufia University, Faculty of medicine
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
32511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31722153
Citation
Coleman RL, Spirtos NM, Enserro D, Herzog TJ, Sabbatini P, Armstrong DK, Kim JW, Park SY, Kim BG, Nam JH, Fujiwara K, Walker JL, Casey AC, Alvarez Secord A, Rubin S, Chan JK, DiSilvestro P, Davidson SA, Cohn DE, Tewari KS, Basen-Engquist K, Huang HQ, Brady MF, Mannel RS. Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer. N Engl J Med. 2019 Nov 14;381(20):1929-1939. doi: 10.1056/NEJMoa1902626.
Results Reference
background
Citation
Du Bois A, Vergote I, Ferron G et al. A randomized controlled phase III study evaluating the impact of secondary cytoreductive surgery in recurrent ovarian cancer: AGO DESKTOP III/ENGOT ov20. J Clin Oncol 2017; 35(Suppl): abstr #5501
Results Reference
background
Learn more about this trial
Secondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers
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