Secondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers

Ovarian Cancer Clinical Trial

Official title:

Clinical Outcomes of Secondary Cytoreductive Surgery in Platinum-resistant Ovarian Cancers With Isolated Recurrence

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04795596
• Other study ID #: 388
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: April 1, 2021
• Est. completion date: April 9, 2022

Study information

• Verified date: April 2022
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 9, 2022
• Est. primary completion date: April 9, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Recurrent Ovarian Carcinoma

Intervention

Procedure:
• secondary cytoreductive surgery
resection of isolated recurrent ovarian carcinoma in platinum resistant disease

Drug:
• Chemotherapy
second line chemotherapy according to investigator's choice

Locations

Country	Name	City	State
Egypt	Menoufia University, Faculty of medicine	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival (PFS)	the time interval between the first relapse and the second relapse	6 months from enrollment
Secondary	Overall survival (OS)	the time interval between the date of diagnosis till the date of death	18 months from enrollment
Secondary	Adverse events (AE)	described according to the CTCAE	6 months from enrollment