Clinical trial · Observational
Cukurova Score Validation Study
Cukurova Score Validation Study in Prediction of Primary Cytoreduction in Advanced Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Despite significant advancements in imaging technologies, surgical techniques, chemotherapeutic regimens, and treatment strategies in recent years, ovarian cancer continues to remain the most deadly gynecological malignancy. Approximately 90% of ovarian cancers originate from the coelomic epithelium or modified mesothelial cells and are classified as epithelial ovarian cancers. The majority of patients with epithelial ovarian cancer (70-80%) present in advanced stages. The primary treatment for advanced-stage (stage 3-4) disease consists of primary cytoreductive surgery followed by adjuvant chemotherapy. Cytoreductive surgery aims to remove all visible tumor implants regardless of the extent of the disease and achieve no visible residual tumor (complete cytoreduction, R0) at the end of the surgery. In cases where R0 cannot be achieved (due to poor general condition and/or extensive tumor that cannot be completely excised surgically), the option of neoadjuvant chemotherapy followed by interval cytoreductive surgery is considered. Primary cytoreductive surgery is still the preferred option and is considered a quality indicator for centers performing advanced-stage ovarian cancer surgeries. Despite advancements in surgery, the decision for interval surgery following primary surgery or neoadjuvant chemotherapy is often based on the surgeon's experience, imaging results, and clinic preferences. Various methods and scores have been published and applied to predict which patients are suitable for primary surgery. The Cukurova score developed in our clinic conceptualizes prioritizing surgical procedures using radiological imaging and diagnostic exploratory laparoscopy to achieve complete cytoreduction in harmony with the patient's clinical and performance status, rather than focusing solely on tumor burden. The score showed high success rates for complete cytoreduction and also was useful in terms of predicting the morbidity and mortality. However, the Cukurova score study was conducted in single center. Validation of scores in centers with different capacities is expected to facilitate their widespread use and acceptance. Therefore, in this study, the investigators plan to conduct a validation study of the score in a total of 20 centers in Turkey, including our center. This study aims to evaluate the validity of the Cukurova score in predicting outcomes of primary cytoreduction in advanced ovarian cancer patients and thus determining the decision for primary cytoreductive surgery or neoadjuvant chemotherapy followed by interval cytoreductive surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Primary Cytoreduction | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of complete cytoreduction
- timeFrame
- 1-3 years
- description
- Complete cytoreduction (R0) is described as no visible residual tumor at the end of the surgery. The primary outcome of this study is to determine the rate of cases resulted with complete cytorection (R0).
Secondary outcomes (1)
- measure
- Rate of postoperative 90-days mortality
- timeFrame
- postoperative 90 days during the study period
- description
- Rate of cases died during 90 days after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years old and over * Suspected advanced ovarian/fallopian tube/ primary peritoneal carcinomatosis on imaging * Pathologically confirmed Stage III-IV epithelial ovarian cancer/fallopian tube/ primary peritoneal carcinomatosis * Consent to participate in the study Exclusion Criteria: * Stage I-II epithelial ovarian/fallopian tube/peritoneal cancer * Nonepithelial Ovarian Cancer * Benign Ovarian tumors * Borderline Ovarian Tumors * Metastatic Ovarian Tumors * Rejecting to Participate in the Study * \<18 years old
References
Publications (4)
- BACKGROUNDKhatib G, Seyfettinoglu S, Kose S, Kucukgoz Gulec U, Avci A, Guzel AB, Unal I, Paydas S, Vardar MA. The Cukurova score in the prediction of primary cytoreduction in ovarian cancer. Int J Gynecol Cancer. 2024 Jan 5;34(1):122-130. doi: 10.1136/ijgc-2023-004736. PMID 37945055
- BACKGROUNDGreimel E, Kristensen GB, van der Burg ME, Coronado P, Rustin G, del Rio AS, Reed NS, Nordal RR, Coens C, Vergote I; European Organization for Research and Treatment of Cancer - Gynaecological Cancer Group and NCIC Clinical Trials Group. Quality of life of advanced ovarian cancer patients in the randomized phase III study comparing primary debulking surgery versus neo-adjuvant chemotherapy. Gynecol Oncol. 2013 Nov;131(2):437-44. doi: 10.1016/j.ygyno.2013.08.014. Epub 2013 Aug 27. PMID 23994107
- BACKGROUNDKehoe S, Hook J, Nankivell M, Jayson GC, Kitchener H, Lopes T, Luesley D, Perren T, Bannoo S, Mascarenhas M, Dobbs S, Essapen S, Twigg J, Herod J, McCluggage G, Parmar M, Swart AM. Primary chemotherapy versus primary surgery for newly diagnosed advanced ovarian cancer (CHORUS): an open-label, randomised, controlled, non-inferiority trial. Lancet. 2015 Jul 18;386(9990):249-57. doi: 10.1016/S0140-6736(14)62223-6. Epub 2015 May 19. PMID 26002111
- BACKGROUNDFagotti A, Ferrandina G, Vizzielli G, Fanfani F, Gallotta V, Chiantera V, Costantini B, Margariti PA, Gueli Alletti S, Cosentino F, Tortorella L, Scambia G. Phase III randomised clinical trial comparing primary surgery versus neoadjuvant chemotherapy in advanced epithelial ovarian cancer with high tumour load (SCORPION trial): Final analysis of peri-operative outcome. Eur J Cancer. 2016 May;59:22-33. doi: 10.1016/j.ejca.2016.01.017. Epub 2016 Mar 19. PMID 26998845