Clinical trial NCT04795596: 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
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Ovarian Cancer
Recurrent Ovarian Carcinoma
Keywords: ovarian cancer
platinum resistant
cytoreductive surgery
recurrent ovarian cancer
complete resection
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: progression free survival (PFS)
timeFrame: 6 months from enrollment
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 18 months from enrollment
measure: Adverse events (AE)
timeFrame: 6 months from enrollment
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University, Faculty of medicine
state: Menoufia
Study officials:
References:
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.
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