Cukurova Score Validation Study

NCT06378905 | Recruiting DMC

• 1 other identifier: 141/57
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Epithelial Ovarian Cancer; Primary Cytoreduction

Keywords

Epithelial Ovarian Cancer; Cytoreduction

Outcome Measures

Primary Outcomes (1)

• Rate of complete cytoreduction

  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).

  1-3 years

Secondary Outcomes (1)

• Rate of postoperative 90-days mortality

  postoperative 90 days during the study period

Other Outcomes (1)

• Rate of postoperative morbidity

  postoperative 28 days during the study period

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who have advanced epithelial ovarian cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead
• Muğla Sıtkı Koçman University: collaborator
• Sakarya University: collaborator
• Gazi University: collaborator
• Ankara Etlik City Hospital: collaborator
• Kayseri City Hospital: collaborator
• Mersin University: collaborator
• Selcuk University: collaborator
• Bezmialem Vakif University: collaborator
• Uludag University: collaborator
• Mersin City Hospital: collaborator
• Marmara University: collaborator
• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: collaborator
• Ankara University: collaborator
• Ege University: collaborator
• Hacettepe University: collaborator
• Akdeniz University: collaborator
• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: collaborator
• Mustafa Kemal University: collaborator
• Trakya University: collaborator

Study Sites (1)

Cukurova University

Adana, 01330, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Khatib 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 BACKGROUND

• Greimel 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 BACKGROUND

• Kehoe 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 BACKGROUND

• Fagotti 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 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Ghanim Khatib, MD

CONTACT

+903223386060; ghanim.khatib@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 23, 2024
• Study Start: May 30, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)