Secondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers

NCT ID: NCT04795596

Last Updated: 2022-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-04-09

Brief Summary

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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

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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

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Ovarian Cancer Recurrent Ovarian Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients with platinum resistant cancer ovary will be randomized to one of two arms; either chemotherapy alone or surgical resection followed by chemotherapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgery + chemotherapy

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

Group Type EXPERIMENTAL

secondary cytoreductive surgery

Intervention Type PROCEDURE

resection of isolated recurrent ovarian carcinoma in platinum resistant disease

Chemotherapy

Intervention Type DRUG

second line chemotherapy according to investigator's choice

chemotherapy alone

second line chemotherapy according to investigator's choice

Group Type ACTIVE_COMPARATOR

Chemotherapy

Intervention Type DRUG

second line chemotherapy according to investigator's choice

Interventions

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secondary cytoreductive surgery

resection of isolated recurrent ovarian carcinoma in platinum resistant disease

Intervention Type PROCEDURE

Chemotherapy

second line chemotherapy according to investigator's choice

Intervention Type DRUG

Other Intervention Names

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re-resection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Sohaib

Principal investigator, Lecturer of Clinical oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menoufia University, Faculty of medicine

Shibīn al Kawm, Menoufia, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 31722153 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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388

Identifier Type: -

Identifier Source: org_study_id

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