NCT04795596

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_2 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2022

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

March 9, 2021

Last Update Submit

April 9, 2022

Conditions

Ovarian CancerRecurrent Ovarian Carcinoma

Keywords

ovarian cancerplatinum resistantcytoreductive surgeryrecurrent ovarian cancercomplete resection

Outcome Measures

Primary Outcomes (1)

  • progression free survival (PFS)

    the time interval between the first relapse and the second relapse

    6 months from enrollment

Secondary Outcomes (2)

  • Overall survival (OS)

    18 months from enrollment

  • Adverse events (AE)

    6 months from enrollment

Study Arms (2)

surgery + chemotherapy

EXPERIMENTAL

surgical resection for recurrent platinum resistant ovarian cancer followed by second line chemotherapy as per the investigator's choice

Procedure: secondary cytoreductive surgeryDrug: Chemotherapy

chemotherapy alone

ACTIVE COMPARATOR

second line chemotherapy according to investigator's choice

Drug: Chemotherapy

Interventions

secondary cytoreductive surgeryPROCEDURE

resection of isolated recurrent ovarian carcinoma in platinum resistant disease

Also known as: re-resection
surgery + chemotherapy
ChemotherapyDRUG

second line chemotherapy according to investigator's choice

chemotherapy alonesurgery + chemotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • not medically fit for surgery
  • diffuse carcinomatosis, ascites, or extra-abdominal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University, Faculty of medicine

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

Related 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.

    PMID: 31722153BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Therapeutics
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: patients with platinum resistant cancer ovary will be randomized to one of two arms; either chemotherapy alone or surgical resection followed by chemotherapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Lecturer of Clinical oncology

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 12, 2021

Study Start

April 1, 2021

Primary Completion

April 9, 2022

Study Completion

April 9, 2022

Last Updated

April 15, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)