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PDS Versus NACT-IDS in AI-Selected Advanced Epithelial Ovarian Cancer

10 de novembro de 2026 atualizado por: Shanghai Gynecologic Oncology Group

Artificial Intelligence -Assisted Randomized Phase II/III Trial of Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer

This multicenter, open-label, randomized phase II/III trial will compare primary debulking surgery (PDS) with neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) in patients with newly diagnosed stage IIIC or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who are recommended for PDS by the MERITS clinical decision tool and are clinically eligible for either treatment strategy.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

The optimal timing of cytoreductive surgery in advanced epithelial ovarian cancer remains uncertain. Earlier randomized trials did not clearly identify which patients benefit from PDS rather than NACT-IDS. Using data from 489 participants in the SUNNY trial, the Multi-Endpoint RMST Ensemble for Individualized Treatment Selection (MERITS) model was developed and internally evaluated in the previous SUNNY-AI trial (NCT06839157). The model uses seven pretreatment clinical variable groups: BRCA status, TNM stage, Eastern Cooperative Oncology Group performance status, histologic type, tumor burden, presence of omental metastasis, and age (≤65 vs >65 years). In internal cross-validation, MERITS recommended PDS for 78.1% of patients and achieved a concordance index of 0.63. The current study will prospectively evaluate the clinical utility of feature-based selection and determine whether PDS improves overall survival in the selected population.

All participants must be recommended for PDS by MERITS and judged clinically suitable for both PDS and NACT-IDS. A 20-participant randomized pioneer study will first assess feasibility and early safety. Formal phase II enrollment may begin if major protocol deviations are observed in no more than 4 of 20 participants, 30-day grade ≥3 postoperative complications in no more than 6, 30-day postoperative deaths in no more than 1, at least 18 undergo the planned debulking procedure, and all operated participants have ascertainable 30-day safety outcomes.

The randomized phase II will enroll 100 participants. Phase II will be assessed after the 100th participant has completed 18 months of follow-up and surgical safety data have been verified. The phase II decision is exploratory and does not establish confirmatory noninferiority. The phase III will enroll 414 participants. The final phase III analysis will be performed after at least 247 deaths and at least 60 months of follow-up for the last phase III participant. Overall survival will be compared using a stratified log-rank test, with a stratified Cox model estimating the hazard ratio for PDS versus NACT-IDS and its two-sided 95% confidence interval. Stratification factors are TNM stage, cPCI tumor burden, and BRCA status. PDS will be considered superior only if the estimated hazard ratio is <1 and the two-sided stratified log-rank P value is <0.05.

Tipo de estudo

Intervencional

Inscrição (Estimado)

534

Estágio

  • Fase 2
  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Zhongshan Hospital Fudan University
        • Contato:
        • Contato:
          • Libing Xiang, MD, PhD
          • Número de telefone: 02164041990
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang cancer hospital
        • Contato:
          • Jianqing Zhu, MD
          • Número de telefone: 86 571 8822222
          • E-mail: zjq-hz@126.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 79 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  • Female, aged ≥18 and <80 years.
  • Newly diagnosed, pathologically confirmed stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma. Diagnostic surgery, core-needle biopsy, or a pleural/ascitic fluid cell block may be used for confirmation as specified in the protocol.
  • PET-CT based TNM clinical stage and cPCI tumor burden determined by multidisciplinary assessment.
  • Eastern Cooperative Oncology Group performance status 0-2.
  • Frailty index <0.15.
  • Known BRCA1/2 status.
  • MERITS recommendation for PDS and clinical eligibility for both randomized treatment strategies.
  • Adequate bone marrow, renal, hepatic, and nutritional function to undergo chemotherapy and surgery: white blood cell count >3,000/µL; absolute neutrophil count ≥1,500/µL; platelets ≥100,000/µL; hemoglobin ≥9 g/dL; serum creatinine <1.25 × upper limit of normal or creatinine clearance ≥60 mL/min; total bilirubin <1.25 × upper limit of normal; ALT and AST <2.5 × upper limit of normal; and serum albumin >3.5 g/dL.
  • Ability and willingness to comply with protocol treatment and scheduled follow-up.
  • Written informed consent.

Exclusion Criteria:

  • Low-grade ovarian carcinoma, mucinous ovarian carcinoma, or clear cell carcinoma.
  • Non-epithelial ovarian malignancy or borderline ovarian tumor.
  • Prior neoadjuvant chemotherapy, targeted therapy, immunotherapy, or other systemic anticancer therapy for the current disease.
  • Concurrent or uncontrolled malignancy diagnosed within the previous 5 years.
  • Severe systemic disease precluding surgery, including poorly controlled diabetes or hypertension, chronic obstructive pulmonary disease, implanted cardiac pacemaker with clinically relevant comorbidity, moderately reduced cardiac ejection fraction, end-stage renal disease, myocardial infarction, cerebrovascular accident, uncontrolled infection, coagulation disorder, or another condition judged to make surgery or chemotherapy unsafe.
  • Inability to complete the planned treatment course or follow-up.
  • Religious, psychological, or other circumstances that could interfere with informed consent, protocol adherence, or follow-up.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Primary Debulking Surgery

Maximal-effort cytoreductive surgery will be completed within 3 weeks after pathologic diagnosis, followed by 6 cycles of first-line chemotherapy. The interval from surgery to the first postoperative chemotherapy cycle should not exceed 8 weeks unless medically necessary.
Procedimento: Upfront cytoreductive surgery

Upfront cytoreductive surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5

Medicamento: Platinum-based chemotherapy

Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5
Comparador Ativo: Neoadjuvant Chemotherapy Followed by Interval Debulking Surgery

Participants will receive 3 cycles of neoadjuvant chemotherapy, undergo interval debulking surgery with maximal-effort cytoreduction, and then receive 3 additional cycles of chemotherapy. The interval from surgery to the first postoperative chemotherapy cycle should not exceed 8 weeks unless medically necessary.
Medicamento: Platinum-based chemotherapy

Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5

Procedimento: Interval debulking surgery

3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Overall survival
Prazo: 60 months since randomization

Time from randomization to death from any cause; participants alive will be censored at the last date known alive.
60 months since randomization

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Progression-free survival
Prazo: 60 months since randomization

Time from randomization to first disease progression or death from any cause, whichever occurs first.
60 months since randomization
Postoperative complications within 30 days after surgery
Prazo: Through 30 days after the planned debulking procedure

The surgical complications will be evaluated at 30-day after upfront cytoreductive surgery or interval debulking surgery, graded using CTCAE version 5.03
Through 30 days after the planned debulking procedure
Quality of life assessments
Prazo: At baseline, 6 months, 12 months, and 5 years after randomization.

Quality of life measured with EORTC QLQ-C30
At baseline, 6 months, 12 months, and 5 years after randomization.
Pattern of first relapse
Prazo: 60 months since randomization

The number and sites of the first relapse, including pelvic, abdominal, retroperitoneal lymph nodes, distant metastases and ascites will be compared between the two groups.
60 months since randomization
The rate of 3-year progression-free survival
Prazo: 36 months since randomization

The rate of the patients without progression or recurrence or death at 3 years.
36 months since randomization
The rate of 5-year progression-free survival
Prazo: 60 months since randomization

The rate of the patients without progression or recurrence or death at 5 years.
60 months since randomization

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Shanghai Gynecologic Oncology Group

Colaboradores

Zhejiang Cancer Hospital
Shanghai Zhongshan Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

31 de dezembro de 2026

Conclusão Primária (Estimado)

28 de fevereiro de 2037

Conclusão do estudo (Estimado)

28 de fevereiro de 2037

Datas de inscrição no estudo

Enviado pela primeira vez

6 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de novembro de 2026

Primeira postagem (Real)

12 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • OV-AI

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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