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| Name | Class |
|---|---|
| Asociación de Amigos de la Universidad de Navarra | UNKNOWN |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary cytoreductive surgery | Patients underwent primary cytoreductive surgery between January 1, 2018, and December 31, 2019. After that, they underwent adjuvant 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytoreductive surgery | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive participant sampling of patients with IIIB-IVB ovarian cancer that underwent primary cytoreductive surgery or interval cytoreductive surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis M Chiva, MD, PhD | Contact | 0034682486041 | 34 | lchiva@unav.es |
| Pilar Ordás, PhD student | Contact | 0034698135349 | 34 | pordascerna@unav.es |
| Name | Affiliation | Role |
|---|---|---|
| Luis M Chiva, MD, PhD | University of Navarra | Study Chair |
| Pilar Ordás, PhD student | University of Navarra | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Universidad de Navarra | Recruiting | Madrid | 28027 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41352872 | Derived | Chiva L, Ordas P, Mishra J, Ayhan A, Lee YY, Bogani G, Sp S, Lomnytska M, Stukan M, Fruscio R, Chura BF, Salcedo-Hernandez RA, De Iaco P, Haidopoulos D, Svintsitskiy V, Jain V, Stanciu P, Rawert FL, Akdemir C, Abdallah R, Chacon E, Minguez JA, Gil-Moreno A, Kharchenko K, Mofrad MH, Gebauer G, Diaz-Feijoo B, Scibilia G, Klaric M, Skof E, Saadeh FA, Mueller MD, Saarelainen S, Tejerizo Garcia A, Fotopoulou C, Coronado P, Dermikiran F, Goffin F, Tsolakidis D, Gonzalez-Martin A; SUROVA Study Group. SUROVA study: global real-world treatment strategies and mortality risk prediction in advanced ovarian cancer. Int J Gynecol Cancer. 2025 Dec;35(12):102688. doi: 10.1016/j.ijgc.2025.102688. | |
| 38479803 |
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| Neoadjuvant chemotherapy | 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 | 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. |
|
| 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. | 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 | 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. | 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. | 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 | 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 | Date of last contact up to 5 years |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| D010534 | Peritoneal Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| D065426 | Cytoreduction Surgical Procedures |
| D020360 | Neoadjuvant Therapy |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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