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

January 15, 2024 updated by: Clinica Universidad de Navarra, Universidad de Navarra

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

SUROVA study tries to compare the outcomes of primary cytoreductive surgery with neoadjuvant chemotherapy and interval cytoreductive surgery in patients with carcinoma of the ovary, fallopian tubes, and peritoneum operated between 2018 and 2019 worldwide.

The objective is to know if the surgical approach influences our patients' survival (OS and PFS). To answer this question, SUROVA is necessary.

While the prospective Trust Trial, with results expected in 2024, is designed to address this question, a limitation of this study is that it is confined to patients treated in high-end hospitals. This limitation could introduce bias in the results, as many patients may lack access to such high-level healthcare facilities. Therefore, the objective is to extend the scope of this study to real life. To achieve this, the investigators are seeking to collect data from patients treated globally during 2018 and 2019, involving both primary and interval cytoreduction.

The investigators hope that the results of this study will be subjected to evaluation at international meetings and published in reputable international journals. Authorship will be based on a rigorous criterion tied to the number of valid cases included in the study. Naturally, the aim is to include as many authors as possible.

The researchers strongly believe that patients would greatly benefit from SUROVA data and that it will address this critical question and provide invaluable insights.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Luis M Chiva, MD, PhD
  • Phone Number: 34 0034682486041
  • Email: lchiva@unav.es

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Luis M Chiva, MD, PhD
          • Phone Number: +34 682486041
          • Email: lchiva@unav.es
        • Contact:
        • Principal Investigator:
          • Luis Chiva, MD, PhD
        • Sub-Investigator:
          • Pilar Ordas, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive participant sampling of patients with IIIB-IVB ovarian cancer that underwent primary cytoreductive surgery or interval cytoreductive surgery.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary cytoreductive surgery
Patients underwent primary cytoreductive surgery between January 1, 2018, and December 31, 2019. After that, they underwent adjuvant therapy.
Procedure: Cytoreductive surgery
Cytoreductive surgery is a surgical procedure performed with the goal of reducing the tumor burden in the body. This type of surgery is commonly used in the treatment of certain types of cancers, especially in the context of peritoneal carcinomatosis. During cytoreductive surgery, the surgeon attempts to remove as much visible tumor as possible. This may involve the removal of tumors from specific organs and the elimination of tumor lesions on the surface of intra-abdominal organs.
Other Names:
  • cytoreduction
  • debulking surgery
Drug: Adjuvant chemotherapy
Adjuvant chemotherapy is chemotherapy given after the primary treatment, such as surgery or radiation therapy, with the aim of eliminating any remaining cancer cells and reducing the risk of recurrence. It is administered to patients who have undergone the initial treatment to enhance the overall effectiveness of the 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.
Procedure: Cytoreductive surgery
Cytoreductive surgery is a surgical procedure performed with the goal of reducing the tumor burden in the body. This type of surgery is commonly used in the treatment of certain types of cancers, especially in the context of peritoneal carcinomatosis. During cytoreductive surgery, the surgeon attempts to remove as much visible tumor as possible. This may involve the removal of tumors from specific organs and the elimination of tumor lesions on the surface of intra-abdominal organs.
Other Names:
  • cytoreduction
  • debulking surgery
Drug: Adjuvant chemotherapy
Adjuvant chemotherapy is chemotherapy given after the primary treatment, such as surgery or radiation therapy, with the aim of eliminating any remaining cancer cells and reducing the risk of recurrence. It is administered to patients who have undergone the initial treatment to enhance the overall effectiveness of the therapy.
Drug: Neoadjuvant chemotherapy
Neoadjuvant chemotherapy refers to chemotherapy administered before the primary treatment in cancer management. The goals include reducing tumor size, treating micrometastases, assessing treatment response, converting inoperable tumors to operable ones, and preserving organs or tissues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival at 5 years
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.
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival at 5 years
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.
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.
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 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 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.
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
Time Frame: Date of last contact up to 5 years
Gather information on surgical treatment approaches and decision-making processes for patients with advanced high-grade ovarian cancer in worldwide centers
Date of last contact up to 5 years
Aletti surgical score
Time Frame: Date of last contact up to 5 years
Extend the surgery according to the Aletti surgical complexity score, which ranges from 1 to 8, with higher scores indicating more complex surgeries.
Date of last contact up to 5 years
Surgical complications: requirement of pharmacological treatment; surgical, endoscopic or radiological intervention, life threatening complications or death.
Time Frame: Date of last contact up to 5 years
Documentation of surgical complications.
Date of last contact up to 5 years
Breast cancer susceptibility gene (BRCA) influence
Time Frame: Date of last contact up to 5 years
Compare the outcomes between patients with BRCA mutations and those without this mutation
Date of last contact up to 5 years
Homologous Recombination Deficiency (HRD) deficiency influence
Time Frame: Date of last contact up to 5 years
Compare the outcomes between patients with HRD deficiency and those with HRD proficiency
Date of last contact up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Asociación de Amigos de la Universidad de Navarra

Investigators

  • Study Chair: Luis M Chiva, MD, PhD, University of Navarra
  • Study Chair: Pilar Ordás, PhD student, University of Navarra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Estimated)

January 25, 2024

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUROVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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