NCT06223763

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 4, 2024

Last Update Submit

January 15, 2024

Conditions

Epithelial Ovarian CancerFallopian Tube NeoplasmsPeritoneal Neoplasms

Keywords

surgerygynecologygynecological surgeryovarian cancerneoadjuvant chemotherapyinterval cytoreductive surgerycytoreductive surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 (7)

  • Progression Free Survival at 5 years

    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.

    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

    Date of last contact up to 5 years

  • Aletti surgical score

    Date of last contact up to 5 years

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

    Date of last contact up to 5 years

  • +2 more secondary outcomes

Study Arms (2)

Primary cytoreductive surgery

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

Procedure: Cytoreductive surgeryDrug: Adjuvant chemotherapy

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 surgeryDrug: Neoadjuvant chemotherapyDrug: Adjuvant chemotherapy

Interventions

Cytoreductive surgeryPROCEDURE

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.

Also known as: debulking surgery, cytoreduction
Interval cytoreductive surgeryPrimary cytoreductive surgery
Neoadjuvant chemotherapyDRUG

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.

Interval cytoreductive surgery
Adjuvant chemotherapyDRUG

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 surgeryPrimary cytoreductive surgery

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Universidad de Navarra

Madrid, 28027, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38479803DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube NeoplasmsPeritoneal NeoplasmsOvarian Neoplasms

Interventions

Cytoreduction Surgical ProceduresNeoadjuvant TherapyChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube DiseasesAbdominal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Luis M Chiva, MD, PhD

    University of Navarra

    STUDY CHAIR

  • Pilar Ordás, PhD student

    University of Navarra

    STUDY CHAIR

Central Study Contacts

Luis M Chiva, MD, PhD

CONTACT

0034682486041lchiva@unav.es

Pilar Ordás, PhD student

CONTACT

0034698135349pordascerna@unav.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 25, 2024

Study Start

January 1, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Locations

ES(1)