An International Retrospective Observational Study Comparing Primary Cytoreductive Surgery With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Patients With Carcinoma of the Ovary, Fallopian Tubes and Peritoneum

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Observational
SUMMARY

An international worldwide retrospective cohort observational study comparing primary cytoreductive surgery with neoadjuvant chemotherapy and interval cytoreductive surgery in patients with carcinoma of the ovary, fallopian tubes, and peritoneum.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• Patients \> 18 years old.

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 at the time of the surgery.

• Invasive high-grade epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma in stage International Federation of Gynecology and Obstetrics (FIGO) IIIB-IVB (IVB only if resectable metastases are present), suspected or histologically confirmed and newly diagnosed.

• Patient underwent primary surgery or first course of neoadjuvant chemotherapy between January 1, 2018, and December 31, 2019.

• American Society of Anesthesiologists Physical Status Classification System (ASA) score 1 or 2 at the time of the surgery.

• Surgery performed by laparotomy with an attempt of maximal effort.

• The surgeon must be a certified or non-certified gynecologic oncologist.

• Based on all available information before the surgery (primary or interval), the patient was considered completely resectable.

• Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.

• Preoperative imaging (either CT, whole-body MRI, or positron emission tomography (PET)-CT) excluding unresectable disease as per European Society of Gynaecological Oncology (ESGO) criteria.

• Surgical report on residual disease after surgery.

Locations
Other Locations
Spain
Clínica Universidad de Navarra
RECRUITING
Madrid
Contact Information
Primary
Luis M Chiva, MD, PhD
lchiva@unav.es
0034682486041
Backup
Pilar Ordás, PhD student
pordascerna@unav.es
0034698135349
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2024-06-01
Participants
Target number of participants: 5000
Treatments
Primary cytoreductive surgery
Patients underwent primary cytoreductive surgery between January 1, 2018, and December 31, 2019. After that, they underwent adjuvant therapy.
Interval cytoreductive surgery
Patients underwent primary first course of neoadjuvant chemotherapy between January 1, 2018, and December 31, 2019. After neoadjuvant chemotherapy, the patient underwent interval cytoreductive surgery and then, adjuvant chemotherapy.
Related Therapeutic Areas
Sponsors
Leads: Clinica Universidad de Navarra, Universidad de Navarra
Collaborators: Asociación de Amigos de la Universidad de Navarra

This content was sourced from clinicaltrials.gov