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

Assiut University

Status: Unknown

Conditions: Advanced Cancer

Treatments: Combination Product: Neoadjuvant chemotherapy followed by surgery; Procedure: 1ry cyto-reductive surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04257786

epithelial ovarian cancer

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group 1

Active Comparator group

Description:

1ry surgery

Treatment:

Procedure: 1ry cyto-reductive surgery

Group 2

Active Comparator group

Description:

Neoadjuvant Chemotherapy followed by surgery

Treatment:

Combination Product: Neoadjuvant chemotherapy followed by surgery