SUROVA - Surgery in Ovarian Cancer, Comparing Primary and Interval Cytoreductive Surgery

NCT06223763UNKNOWNOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Enrollment

5000

Start Date

2024-01-01

Completion Date

2024-06-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Cytoreductive surgeryNeoadjuvant chemotherapyAdjuvant chemotherapy

Conditions

Epithelial Ovarian CancerFallopian Tube NeoplasmsPeritoneal Neoplasms

Eligibility

Sex

FEMALE

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Non-epithelial malignant ovarian neoplasms and borderline tumors.
* Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any 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 the mediastinum in CT chest and abdomen/pelvis before surgery (primary or interval).
* Pregnant women at the time of diagnosis.

Outcome Measures

Primary Outcomes

Overall Survival at 5 years

Compare overall survival (OS) at 5 years in patients who underwent primary cytoreductive surgery vs. neoadjuvant chemotherapy and interval cytoreductive surgery for stage IIIB-IVB ovarian cancer.

Time frame: From date of the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) to death from ovarian cancer or last follow up, assessed at the 5-year mark.

Secondary Outcomes

Progression Free Survival at 5 years

Compare Progression Free Survival (PFS) at 5 years in patients who underwent primary cytoreductive surgery vs. neoadjuvant chemotherapy and interval cytoreductive surgery for stage IIIB-IVB ovarian cancer.

Time frame: From date of the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) to death from ovarian cancer or last follow up assessed at the 5-year mark.

Time to first and second subsequent anticancer therapy or death.

Time to first subsequent anticancer therapy is calculated from the date of first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) until the starting date of the first subsequent anticancer therapy or death, whichever occurs first or date of last contact (censored observation). Maintenance treatments following a cytostatic treatment are not considered separate treatment lines.

Time frame: From date of the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery) to death from ovarian cancer or last follow up assessed at the 5-year mark.

Information on surgical treatment approaches

Gather information on surgical treatment approaches and decision-making processes for patients with advanced high-grade ovarian cancer in worldwide centers

Time frame: Date of last contact up to 5 years

Aletti surgical score

Extend the surgery according to the Aletti surgical complexity score, which ranges from 1 to 8, with higher scores indicating more complex surgeries.

Time frame: Date of last contact up to 5 years

Surgical complications: requirement of pharmacological treatment; surgical, endoscopic or radiological intervention, life threatening complications or death.

Documentation of surgical complications.

Time frame: Date of last contact up to 5 years

Breast cancer susceptibility gene (BRCA) influence

Compare the outcomes between patients with BRCA mutations and those without this mutation

Time frame: Date of last contact up to 5 years

Homologous Recombination Deficiency (HRD) deficiency influence

Compare the outcomes between patients with HRD deficiency and those with HRD proficiency

Time frame: Date of last contact up to 5 years

Locations

Clínica Universidad de Navarra, Madrid, Spain

Linked Papers

2024-06-03

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 (SUROVA trial)

Currently, a lively debate exists within the scientific community regarding the most suitable procedure for treating stages IIIB-IVB carcinoma of the ovary, fallopian tubes, and peritoneum. The options under most consideration are primary cytoreductive surgery or neoadjuvant chemotherapy followed by interval cytoreductive surgery. To compare overall survival at 5 years in patients who underwent primary cytoreductive surgery versus neoadjuvant chemotherapy and interval cytoreductive surgery for stage IIIB-IVB ovarian cancer STUDY HYPOTHESIS: The treatment with primary cytoreductive surgery results in superior patient survival compared with neoadjuvant chemotherapy followed by interval cytoreductive surgery. This is a multicenter, retrospective cohort observational study. Data will be collected from patients undergoing surgery in hospitals worldwide. Two arms will be compared: primary cytoreductive surgery and neoadjuvant chemotherapy followed by interval cytoreductive surgery. Patients must have suspected or histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stages IIIB-IVB ovarian, peritoneal, or fallopian tube cancers. They must have undergone primary surgery or first course of neoadjuvant chemotherapy between January 1, 2018 and December 31, 2019. Based on all available information before the surgery (primary or interval), the patient must have been considered completely resectable. Overall survival at 5 years from the first treatment (chemotherapy in the case of neoadjuvant chemotherapy and cytoreduction in the case of primary cytoreductive surgery). An estimated total of 5000 patients will be enrolled in the study. March 2025 TRIAL REGISTRATION: NCT06223763.

Linked Investigators

Antonio Gonzalez-Martin

Antonio González-Martín graduated in medicine at the University of Navarra in Pamplona (Spain) and subsequently trained in medical oncology at University Hospital Ramón y Cajal in Madrid (Spain) from 1994 to 1997. During part of 1997, he attended as an observer to The Mount Sinai School of Medicine in New York. He joined as a staff member of the Medical Oncology Service at University Hospital Ramón y Cajal in 1998. From January 2009 he gained the position of Head of Medical Oncology Department at MD Anderson Cancer Center Madrid·Spain, an affiliate institution of MD Anderson in Houston. Since September 2017 he joined Clínica Universidad de Navarra in Madrid as head of Medical Oncology and co-director of the Oncology Department. Since 2020 he was appointed as Director of Cancer Centre Universidad de Navarra. He is an Associate Professor at Medicine at Francisco de Vitoria University in Madrid (Spain), collaborator Professor at Universidad de Navarra and Adjunct Professor at the University of Texas (TX, USA). He got the PhD degree at Francisco de Vitoria University in April 2018. He specialises in the treatment of gynaecological and breast cancer and is the chairman of GEICO (Spanish group for investigation in ovarian and gynaecological cancer). He is also the representative of GEICO in ENGOT (European Network for Gynaecological Oncological Trials), and was the President of this Group for the period 2018-2020. In addition, he is one of the representatives of GEICO in Gynaecologic Cancer InterGroup (GCIG), and has served as chair of the ovarian cancer committee for the period 2014-2020. He is also a member of the board of the Spanish Society of Medical Oncology (SEOM), and a member of GEICAM and SOLTI breast cancer cooperative groups. He has several relevant publications in the field of gynaecological and breast cancer. He is considered an expert in gynaecological cancer and has lectured widely on these areas of interest.

Daniel Vázquez-Vicente

Enrique Chacon

Jose Angel Minguez

Luisa Sanchez-Lorenzo

Luis Chiva

Nabil Manzour

Teresa Castellanos

SUROVA - Surgery in Ovarian Cancer, Comparing Primary and Interval Cytoreductive Surgery