Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) in Epithelial Ovarian Cancer

NCT ID: NCT04257786

Last Updated: 2020-02-06

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-04-01

Brief Summary

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Assessment of efficacy of primary cyto-reductive surgery in patients with advanced primary epithelial ovarian cancer in Comparison to patients receiving neo-adjuvant chemotherapy (NAC) followed by surgery in complete excision of the tumor reaching R0 without significant morbidity.

Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

1ry surgery

Group Type ACTIVE_COMPARATOR

1ry cyto-reductive surgery

Intervention Type PROCEDURE

1ry surgery then chemotherapy

Group 2

Neoadjuvant Chemotherapy followed by surgery

Group Type ACTIVE_COMPARATOR

Neoadjuvant chemotherapy followed by surgery

Intervention Type COMBINATION_PRODUCT

chemotherapy then surgery

Interventions

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1ry cyto-reductive surgery

1ry surgery then chemotherapy

Intervention Type PROCEDURE

Neoadjuvant chemotherapy followed by surgery

chemotherapy then surgery

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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1ry surgery Neoadjuvant chemotherapy

Eligibility Criteria

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Inclusion Criteria

Female patients diagnosed with epithelial ovarian cancer (By histopathology)

Age ≥ 18 years old

Advanced defined as (stage 2D or more ) by surgical staging.

Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) ≤ 2

Chemotherapy naïve

Informed consent

Exclusion Criteria

Patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis.

Patients with uncontrolled infection.

Patients with active bleeding or conditions associated with high risk of bleeding.

contraindications for surgery

contraindications To chemotherapy - bevacizumab
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ali hussien ali sayed

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ali hussien Ali sayed

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali H Ali Sayed, M.Sc

Role: CONTACT

02 01061830890

References

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Abutaleb H, Hussien A, Khalaf M, Badary DM, Ismail AM, Hassanein S, AlGizawy S, Moustafa SAM, Farghaly RMM, Abdel-Kawi AF. Primary Cytoreductive Surgery Versus Neoadjuvant Chemotherapy Followed by Surgery in Patients with Advanced Primary Epithelial Ovarian Cancer in Low Resources Setting: A Randomized Clinical Trial. J Obstet Gynaecol India. 2025 Jun;75(3):199-205. doi: 10.1007/s13224-024-02061-w. Epub 2024 Nov 6.

Reference Type DERIVED
PMID: 40584804 (View on PubMed)

Other Identifiers

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epithelial ovarian cancer

Identifier Type: -

Identifier Source: org_study_id

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