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

NCT ID: NCT06223763

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-06-01

Brief 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.

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.

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Neoplasms; Peritoneal Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Primary cytoreductive surgery

Patients underwent primary cytoreductive surgery between January 1, 2018, and December 31, 2019. After that, they underwent adjuvant therapy.

Cytoreductive surgery

Intervention Type: PROCEDURE

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.

Adjuvant chemotherapy

Intervention Type: DRUG

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.

Cytoreductive surgery

Intervention Type: PROCEDURE

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.

Neoadjuvant chemotherapy

Intervention Type: DRUG

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.

Adjuvant chemotherapy

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

debulking surgery; cytoreduction

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Asociación de Amigos de la Universidad de Navarra

UNKNOWN

Sponsor Role: collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis M Chiva, MD, PhD

Role: STUDY_CHAIR

University of Navarra

Pilar Ordás, PhD student

Role: STUDY_CHAIR

University of Navarra

Locations

Clínica Universidad de Navarra

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Luis M Chiva, MD, PhD

Role: CONTACT

lchiva@unav.es

0034682486041 ext. 34

Pilar Ordás, PhD student

Role: CONTACT

pordascerna@unav.es

0034698135349 ext. 34

Facility Contacts

Luis M Chiva, MD, PhD

Role: primary

lchiva@unav.es

682486041 ext. +34

Role: backup

lchiva@unav.es

References

Chiva L, Ordas P, Martin-Calvo N, Aramendia JM, Sanchez Lorenzo L, Gallego Martinez A, Vizcay A, Minguez JA, Manzour N, Vazquez-Vicente D, Chacon E, Castellanos T, Gonzalez Martin A. 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). Int J Gynecol Cancer. 2024 Jun 3;34(6):942-945. doi: 10.1136/ijgc-2024-005354.

Reference Type: DERIVED

PMID: 38479803 (View on PubMed)

Other Identifiers

SUROVA

Identifier Type: -

Identifier Source: org_study_id