Last updated: January 15, 2024
Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Overall Status: Active - Recruiting
Phase
N/A
Condition
Digestive System Neoplasms
Peritoneal Cancer
Ovarian Cysts
Treatment
Cytoreductive surgery
Adjuvant chemotherapy
Neoadjuvant chemotherapy
Clinical Study ID
NCT06223763
SUROVA
Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients > 18 years old.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 at the time of thesurgery.
- Invasive high-grade epithelial ovarian cancer, fallopian tube carcinoma, or primaryperitoneal carcinoma in stage International Federation of Gynecology and Obstetrics (FIGO) IIIB-IVB (IVB only if resectable metastases are present), suspected orhistologically confirmed and newly diagnosed.
- Patient underwent primary surgery or first course of neoadjuvant chemotherapy betweenJanuary 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), thepatient 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 GynaecologicalOncology (ESGO) criteria.
- Surgical report on residual disease after surgery.
Exclusion
Exclusion Criteria:
- Non-epithelial malignant ovarian neoplasms and borderline tumors.
- Secondary invasive neoplasms in the last 5 years (except synchronal endometrialcarcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or withany signs of relapse or activity.
- Recurrent ovarian cancer.
- Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy.
- Unresectable parenchymal lung metastasis, liver metastasis or bulky lymph-nodes in themediastinum in CT chest and abdomen/pelvis before surgery (primary or interval).
- Pregnant women at the time of diagnosis.
Study Design
Total Participants: 5000
Treatment Group(s): 3
Primary Treatment: Cytoreductive surgery
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
June 01, 2024
Study Description
Connect with a study center
Clínica Universidad de Navarra
Madrid, 28027
SpainActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.