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Centralization and Oncologic Outcomes in Ovarian Cancer

NCT07075939Active, Not RecruitingOBSERVATIONAL

Summary

This is a multicenter, observational, retrospective and prospective study conducted within the REMO (Reggio Emilia - Modena) network in the Emilia-Romagna region (Italy), promoted by AUSL-IRCCS of Reggio Emilia. The study aims to evaluate the impact of surgical centralization and treatment strategies adopted during the COVID-19 pandemic on oncologic outcomes in patients diagnosed with the epithelial ovarian cancer (EOC) from 2018 to 2023. The retrospective component includes patients treated between 2018 and 2023, while the prospective component consists of clinical follow-up of those patients over the next five years.

Key Facts

Lead Sponsor

Azienda USL Reggio Emilia - IRCCS

Enrollment

200

Start Date

2025-06-27

Completion Date

2030-06-01

Study Type

OBSERVATIONAL

Official Title

Centralization and Oncologic Outcomes in Ovarian Cancer: A Multicenter Retrospective and Prospective Observational Study Within the REMO Network (COOC-REMO)

Interventions

No Intervention: Observational Cohort

Conditions

Epithelial Ovarian CancerOvarian NeoplasmsAdvanced Ovarian Cancer

Eligibility

Age Range

18 Years – 99 Years

Sex

FEMALE

Inclusion Criteria:

* Female patients aged between 18 and 99 years
* Histological and/or cytological diagnosis of epithelial ovarian cancer
* Patients evaluated by the Multidisciplinary Tumor Board (MTB) of the AUSL-IRCCS of Reggio Emilia
* Patients treated between January 1, 2018, and December 31, 2023
* Availability of clinical records and outcome data
* Signed informed consent where possible, in accordance with GDPR and Italian regulations

Exclusion Criteria:

* Patients without histological or cytological confirmation of epithelial ovarian cancer
* Incomplete or missing data for key clinical indicators
* Patients unable to provide informed consent and for whom recontact is not possible
* Patients deemed unable to understand and provide consent (e.g., severe cognitive impairment)

Outcome Measures

Primary Outcomes

Progression-Free Survival (PFS)

Time from initial diagnosis of epithelial ovarian cancer to the date of first documented disease progression or death from any cause, whichever occurs first.

Time frame: Up to 5 years from diagnosis

Overall Survival (OS)

Time from initial diagnosis to death from any cause. Patients still alive will be censored at the date of last follow-up.

Time frame: Up to 5 years from diagnosis

Secondary Outcomes

Type of treatment received after initial diagnosis

Classification of treatment pathways including type of surgery (primary or interval debulking), type of chemotherapy (neoadjuvant, adjuvant, or palliative), and use of maintenance therapies.

Time frame: Within 12 months from diagnosis

Use of targeted therapies (Bevacizumab and/or PARP inhibitors)

Percentage of patients treated with Bevacizumab, PARP inhibitors, or both, in adjuvant or maintenance settings.

Time frame: Within 12 months from completion of first-line chemotherapy

Rate and characteristics of recurrence

Frequency, site, and symptoms of disease recurrence, and rate of patients undergoing secondary surgery or radiotherapy.

Time frame: Up to 5 years from diagnosis

Rate of radiotherapy use in recurrent disease

Proportion of patients with recurrence treated with radiotherapy, including treatment site, dose, and clinical response.

Time frame: Up to 5 years from diagnosis

Locations

Azienda Unità - Sanitaria locale di Modena - Ospedale Razzini Carpi, Carpi, Italy

Azienda Unità - Sanitaria locale di Modena - Ospedale di Mirandola, Mirandola, Italy

Azienda Unità - Sanitaria locale di Modena - Ospedale Pavullo nel Frignano, Pavullo nel Frignano, Italy

Azienda Unità - Sanitaria locale di Modena - Ospedale Civile Sassuolo, Sassuolo, Italy

Azienda Unità - Sanitaria locale di Modena - Ospedale di Vignola, Vignola, Italy

Azienda USL IRCCS di Reggio Emilia, Reggio Emilia, Italy

Azienda Ospedaliero - Universitario di Modena, Modena, Italy

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

Linked Papers

2023-06-26

Impact of 2 years of COVID‐19 pandemic on ovarian cancer treatment in IRCCS‐AUSL of Reggio Emilia

AbstractObjectiveTo assess compliance with the 2019 regional recommendation to centralize epithelial ovarian cancer (EOC) patients and to assess whether the COVID‐19 pandemic has affected the quality of care for EOC patients.MethodsWe compared data from EOC patients treated before the introduction of the 2019 regional recommendation (2018‐2019) with data obtained from EOC patients treated after the regional recommendation was adopted during the first 2 years of the COVID‐19 pandemic (2020‐2021). Data were retrieved from the Optimal Ovarian Cancer Pathway records. R software version 4.1.2 (the R Foundation for Statistical Computing, Vienna, Austria) was used for the statistical analysis.Results251 EOC patients were centralized. The number of EOC patients centralized increased from 2% to 49% despite the COVID‐19 pandemic. During the COVID‐19 pandemic, there was an increase in the use of neoadjuvant chemotherapy and interval debulking surgery. There was an improvement in the percentage of Stage III patients without gross residual disease following both primary and interval debulking surgery. The percentage of EOC cases discussed by the multidisciplinary tumor board (MTB) increased from 66% to 89% of cases.ConclusionDespite the COVID‐19 pandemic, centralization has increased and the quality of care has been preserved thanks to the MTB.

2022-08-15

Primary or Interval Debulking Surgery in Advanced Ovarian Cancer: a Personalized Decision—a Literature Review

Summarize the writings published in the last 5 years on the management of surgery in the first line of treatment for advanced ovarian cancer. For patients with a significant tumor burden, the neoadjuvant chemotherapy therapy (NACT) with interval debulking surgery (IDS) strategy shows comparable efficacy than primary debulking surgery (PDS) in terms of survival in randomized studies with less morbidity. Advanced epithelial ovarian cancer generates more than half cases a recurrence. First-line treatment is based on a chemotherapy regimen combining a platinum-based and a taxane-based, associated with surgery. This review considers papers of last 5 years of timing, thinking tools, and innovation in the management. The choice of strategy, PDS or IDS, would be a personalized recommendation. The challenge is to adapt the timing of the surgery to the patient's characteristics and that of her disease.

2021-09-28

The “collateral damage” of the war on COVID-19: impact of the pandemic on the care of epithelial ovarian cancer

The covid-19 pandemic has impacted the management of non-covid-19 illnesses. Epithelial ovarian cancer (EOC) requires long-duration multidisciplinary treatment. Teleconsultation and shared care are suggested solutions to mitigate the consequences of the pandemic. However, these may be challenging to implement among patients who come from the lower economic strata. We report the disastrous impact of the pandemic on the care of EOC by comparing patients who were treated during the pandemic with those treated in the previous year. We collected the following data from newly diagnosed patients with EOC: time from diagnosis to treatment, time for completion of planned chemotherapy, and proportion of patients completing various components of therapy (surgery and chemotherapy). Patients treated between January 2019 and September 2019 (Group 1: Pre-covid) were compared with those treated between January 2020 and December 2020 (Group 2: During covid pandemic). A total of 82 patients were registered [Group 1: 43(51%) Group 2: 39(49)]. The median time from diagnosis to start of treatment was longer in group 2 when compared to group 1 [31(23-58) days versus 17(11-30) days (p = 0.03)]. The proportion of patients who had surgery in group 2 was lower in comparison to group 1 [33(77%) versus 21(54%) (p = 0.02)]. Proportion of patients who underwent neoadjuvant (NACT) and surgery were fewer in group 2 in comparison to group 1 [9(33%) versus 18(64%) p = 0.002]. Among patients planned for adjuvant chemotherapy, the median time from diagnosis to treatment was longer in group 2 [28(17-45) days, group 1 versus 49(26-78) days, group 2 (p = 0.04)]. The treatment of patients with EOC was adversely impacted due to the COVID-19 pandemic. There was a compromise in the proportion of patients completing planned therapy. Even among those who completed the treatment, there were considerable delays when compared with the pre-covid period. The impact of these compromises on the outcomes will be known with longer follow-up.

2020-02-20

Quality indicators for advanced ovarian cancer surgery from the European Society of Gynaecological Oncology (ESGO): 2020 update

Linked Investigators

Christina Fotopoulou

Delphine Hudry

Prasanth Ganesan

Vincenzo Dario Mandato