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

Launched by CLINICA UNIVERSIDAD DE NAVARRA, UNIVERSIDAD DE NAVARRA · Jan 15, 2024

Nctid: NCT06223763

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Neoplasms"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D000006058", "term"=>"Gonadal Disorders"}, {"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000000008", "term"=>"Abdominal Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000010532", "term"=>"Peritoneal Diseases"}, {"id"=>"D000005184", "term"=>"Fallopian Tube Diseases"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M12974", "name"=>"Ovarian Neoplasms", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}, {"id"=>"M1704", "name"=>"Carcinoma, Ovarian Epithelial", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}, {"id"=>"M13443", "name"=>"Peritoneal Neoplasms", "asFound"=>"Peritoneal Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M8328", "name"=>"Fallopian Tube Neoplasms", "asFound"=>"Fallopian Tube Neoplasms", "relevance"=>"HIGH"}, {"id"=>"M7863", "name"=>"Endocrine Gland Neoplasms", "relevance"=>"LOW"}, {"id"=>"M12972", "name"=>"Ovarian Diseases", "relevance"=>"LOW"}, {"id"=>"M3643", "name"=>"Adnexal Diseases", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8943", "name"=>"Genital Diseases, Female", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8945", "name"=>"Genital Neoplasms, Female", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"M9163", "name"=>"Gonadal Disorders", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M7", "name"=>"Abdominal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M13441", "name"=>"Peritoneal Diseases", "relevance"=>"LOW"}, {"id"=>"M8327", "name"=>"Fallopian Tube Diseases", "relevance"=>"LOW"}, {"id"=>"T4352", "name"=>"Ovarian Cancer", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}, {"id"=>"T4354", "name"=>"Ovarian Epithelial Cancer", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>5000}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-06-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-15", "studyFirstSubmitDate"=>"2024-01-04", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Overall Survival at 5 years", "timeFrame"=>"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.", "description"=>"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."}], "secondaryOutcomes"=>[{"measure"=>"Progression Free Survival at 5 years", "timeFrame"=>"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.", "description"=>"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."}, {"measure"=>"Time to first and second subsequent anticancer therapy or death.", "timeFrame"=>"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.", "description"=>"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."}, {"measure"=>"Information on surgical treatment approaches", "timeFrame"=>"Date of last contact up to 5 years", "description"=>"Gather information on surgical treatment approaches and decision-making processes for patients with advanced high-grade ovarian cancer in worldwide centers"}, {"measure"=>"Aletti surgical score", "timeFrame"=>"Date of last contact up to 5 years", "description"=>"Extend the surgery according to the Aletti surgical complexity score, which ranges from 1 to 8, with higher scores indicating more complex surgeries."}, {"measure"=>"Surgical complications: requirement of pharmacological treatment; surgical, endoscopic or radiological intervention, life threatening complications or death.", "timeFrame"=>"Date of last contact up to 5 years", "description"=>"Documentation of surgical complications."}, {"measure"=>"Breast cancer susceptibility gene (BRCA) influence", "timeFrame"=>"Date of last contact up to 5 years", "description"=>"Compare the outcomes between patients with BRCA mutations and those without this mutation"}, {"measure"=>"Homologous Recombination Deficiency (HRD) deficiency influence", "timeFrame"=>"Date of last contact up to 5 years", "description"=>"Compare the outcomes between patients with HRD deficiency and those with HRD proficiency"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["surgery", "gynecology", "gynecological surgery", "ovarian cancer", "neoadjuvant chemotherapy", "interval cytoreductive surgery", "cytoreductive surgery"], "conditions"=>["Epithelial Ovarian Cancer", "Fallopian Tube Neoplasms", "Peritoneal Neoplasms"]}, "descriptionModule"=>{"briefSummary"=>"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.", "detailedDescription"=>"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.\n\nThe objective is to know if the surgical approach influences our patients' survival (OS and PFS). To answer this question, SUROVA is necessary.\n\nWhile 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.\n\nThe 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.\n\nThe researchers strongly believe that patients would greatly benefit from SUROVA data and that it will address this critical question and provide invaluable insights."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Consecutive participant sampling of patients with IIIB-IVB ovarian cancer that underwent primary cytoreductive surgery or interval cytoreductive surgery.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients \\> 18 years old.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 at the time of the surgery.\n* 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.\n* Patient underwent primary surgery or first course of neoadjuvant chemotherapy between January 1, 2018, and December 31, 2019.\n* American Society of Anesthesiologists Physical Status Classification System (ASA) score 1 or 2 at the time of the surgery.\n* Surgery performed by laparotomy with an attempt of maximal effort.\n* The surgeon must be a certified or non-certified gynecologic oncologist.\n* Based on all available information before the surgery (primary or interval), the patient was considered completely resectable.\n* Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.\n* 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.\n* Surgical report on residual disease after surgery.\n\nExclusion Criteria:\n\n* Non-epithelial malignant ovarian neoplasms and borderline tumors.\n* 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.\n* Recurrent ovarian cancer.\n* Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy.\n* Unresectable parenchymal lung metastasis, liver metastasis or bulky lymph-nodes in the mediastinum in CT chest and abdomen/pelvis before surgery (primary or interval).\n* Pregnant women at the time of diagnosis."}, "identificationModule"=>{"nctId"=>"NCT06223763", "acronym"=>"SUROVA", "briefTitle"=>"SUROVA - Surgery in Ovarian Cancer, Comparing Primary and Interval Cytoreductive Surgery", "organization"=>{"class"=>"OTHER", "fullName"=>"Clinica Universidad de Navarra, Universidad de Navarra"}, "officialTitle"=>"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", "orgStudyIdInfo"=>{"id"=>"SUROVA"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Primary cytoreductive surgery", "description"=>"Patients underwent primary cytoreductive surgery between January 1, 2018, and December 31, 2019. After that, they underwent adjuvant therapy.", "interventionNames"=>["Procedure: Cytoreductive surgery", "Drug: Adjuvant chemotherapy"]}, {"label"=>"Interval cytoreductive surgery", "description"=>"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.", "interventionNames"=>["Procedure: Cytoreductive surgery", "Drug: Neoadjuvant chemotherapy", "Drug: Adjuvant chemotherapy"]}], "interventions"=>[{"name"=>"Cytoreductive surgery", "type"=>"PROCEDURE", "otherNames"=>["debulking surgery", "cytoreduction"], "description"=>"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.", "armGroupLabels"=>["Interval cytoreductive surgery", "Primary cytoreductive surgery"]}, {"name"=>"Neoadjuvant chemotherapy", "type"=>"DRUG", "description"=>"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.", "armGroupLabels"=>["Interval cytoreductive surgery"]}, {"name"=>"Adjuvant chemotherapy", "type"=>"DRUG", "description"=>"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.", "armGroupLabels"=>["Interval cytoreductive surgery", "Primary cytoreductive surgery"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"28027", "city"=>"Madrid", "status"=>"RECRUITING", "country"=>"Spain", "contacts"=>[{"name"=>"Luis M Chiva, MD, PhD", "role"=>"CONTACT", "email"=>"lchiva@unav.es", "phone"=>"682486041", "phoneExt"=>"+34"}, {"role"=>"CONTACT", "email"=>"lchiva@unav.es", "phoneExt"=>"Chiva Chiva"}, {"name"=>"Luis Chiva, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Pilar Ordas, PhD", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Clínica Universidad de Navarra", "geoPoint"=>{"lat"=>40.4165, "lon"=>-3.70256}}], "centralContacts"=>[{"name"=>"Luis M Chiva, MD, PhD", "role"=>"CONTACT", "email"=>"lchiva@unav.es", "phone"=>"0034682486041", "phoneExt"=>"34"}, {"name"=>"Pilar Ordás, PhD student", "role"=>"CONTACT", "email"=>"pordascerna@unav.es", "phone"=>"0034698135349", "phoneExt"=>"34"}], "overallOfficials"=>[{"name"=>"Luis M Chiva, MD, PhD", "role"=>"STUDY_CHAIR", "affiliation"=>"University of Navarra"}, {"name"=>"Pilar Ordás, PhD student", "role"=>"STUDY_CHAIR", "affiliation"=>"University of Navarra"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Clinica Universidad de Navarra, Universidad de Navarra", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Asociación de Amigos de la Universidad de Navarra", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}