Ovarian CancerPhase 2/3NCT04795596
Secondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers
A Phase 2/3 study testing secondary cytoreductive surgery and Chemotherapy in people with Ovarian Cancer and Recurrent Ovarian Carcinoma, run by Menoufia University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer, Recurrent Ovarian Carcinoma
- What is being tested?
- secondary cytoreductive surgery and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 9 Apr 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- not medically fit for surgery
- diffuse carcinomatosis, ascites, or extra-abdominal disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Menoufia University, Faculty of medicine
Shibīn al Kawm, Menoufia, 32511
About this study
Official title: Clinical Outcomes of Secondary Cytoreductive Surgery in Platinum-resistant Ovarian Cancers With Isolated Recurrence
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.
Read the 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.
- Conditions
- Ovarian Cancer, Recurrent Ovarian Carcinoma
- Being tested
- secondary cytoreductive surgery, Chemotherapy
- Keywords
- ovarian cancer, platinum resistant, cytoreductive surgery, recurrent ovarian cancer, complete resection
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secondary cytoreductive surgeryProcedure or surgery
Also called re-resection
resection of isolated recurrent ovarian carcinoma in platinum resistant disease
ChemotherapyDrug
second line chemotherapy according to investigator's choice
| Study group | Role | What they receive |
|---|---|---|
| surgery + chemotherapy | Experimental | surgical resection for recurrent platinum resistant ovarian cancer followed by second line chemotherapy as per the investigator's choice Receives: Procedure: secondary cytoreductive surgery; Drug: Chemotherapy |
| chemotherapy alone | Active comparator | second line chemotherapy according to investigator's choice Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival (PFS)
the time interval between the first relapse and the second relapse
Measured: 6 months from enrollment
Secondary outcomes (2)
Overall survival (OS)
the time interval between the date of diagnosis till the date of death
Measured: 18 months from enrollment
Adverse events (AE)
described according to the CTCAE
Measured: 6 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Apr 2021
- Primary completion9 Apr 2022
- Study completion9 Apr 2022
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sohaib, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795596
- Sponsor's protocol ID
- 388
- Status last verified
- Apr 2022
- First submitted
- 9 Mar 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31722153Du 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Secondary Cytoreductive Surgery in Platinum-resistant Ovarian Cancers With Isolated Recurrence
- ClinicalTrials.gov ID
- NCT04795596
- Acronym / sponsor ID
- 388
- Conditions
- Ovarian Cancer, Recurrent Ovarian Carcinoma
- Keywords
- ovarian cancer, platinum resistant, cytoreductive surgery, recurrent ovarian cancer, complete resection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 9 Apr 2022 (actual)
- Study completion
- 9 Apr 2022 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| surgery + chemotherapy | Experimental | Procedure: secondary cytoreductive surgery, Drug: Chemotherapysurgical resection for recurrent platinum resistant ovarian cancer followed by second line chemotherapy as per the investigator's choice |
| chemotherapy alone | Active comparator | Drug: Chemotherapysecond line chemotherapy according to investigator's choice |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- not medically fit for surgery
- diffuse carcinomatosis, ascites, or extra-abdominal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| secondary cytoreductive surgeryAlso: re-resectionresection of isolated recurrent ovarian carcinoma in platinum resistant disease | Procedure or surgery | surgery + chemotherapy |
| Chemotherapysecond line chemotherapy according to investigator's choice | Drug | chemotherapy alone, surgery + chemotherapy |
Primary outcome
progression free survival (PFS)
Time frame: 6 months from enrollment
the time interval between the first relapse and the second relapse
2 secondary outcomes
Overall survival (OS)
Time frame: 18 months from enrollment
Adverse events (AE)
Time frame: 6 months from enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Background: PubMed 31722153Coleman 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.
- BackgroundDu 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing secondary cytoreductive surgery and Chemotherapy in people with Ovarian Cancer and Recurrent Ovarian Carcinoma, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (PFS) (time frame: 6 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04795596, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.