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NCT Number: NCT06404671

Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer

Ovarian cancer is among the top five primary causes of cancer-related mortality in women. Most ovarian malignant tumours originate from epithelial cells The majority of patients typically have advanced-stage tumours at diagnosis. When complete surgery with no macroscopic visible disease is not feasible due to both the spread of the disease and the patient's general condition, neoadjuvant chemotherapy (NACT) of 3 cycles followed by interval cytoreductive surgery (ICS) or final cytoreductive surgery (FCS) after 6 cycles of NACT followed or not by adjuvant chemotherapy can be offered, with similar overall survival. In our centre, due to logistics, disease, or patient factors, many patients may receive more than 3 cycles of NACT before ICS. Therefore, this randomized controlled trial aims to evaluate the survival benefit of different timings of ICS after 3 or 6 cycles of NACT in patients not eligible for upfront cytoreductive surgery (UCS).

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Elshatby Maternity University Hospital

Alexandria, Egypt

Location status: Recruiting

Location contact

Mervat Elsersy, PhD

CONTACT

[email protected]

+20 109 6311548

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female Patients aged 18 to 75 years.
  • International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-IV unsuitable for UCS.
  • Histologically confirmed high-grade serous (HGS) ovarian, fallopian tube, or primary peritoneal carcinoma.
  • ECOG performance status: 0 or 1.
  • Resectable disease by laparoscopic assessment after 3 cycles of NACT.
  • Adequate haematology, bone marrow, respiratory, hepatic, cardiac and renal functions.
  • Estimated life expectancy of > 3 months according to Age-adjusted Charlston Co-morbidity Index (ACCI), included patients should have a low or intermediate comorbidity score; ACCI 0-3.

Exclusion criteria

  • Metastatic ovarian carcinoma.
  • Patients with primary ovarian carcinoma other than high-grade serous (low-grade serous, endometrioid, mucinous, clear cell, and non-epithelial ovarian carcinoma).
  • Presence of pregnancy or breast-feeding.
  • History of other invasive malignancies in the previous 5 years.
  • History of a recent < 6 month cerebrovascular accident.
  • Uncontrolled systemic disease or contraindication to chemotherapy.
  • Progressive disease on NACT.
  • Worsening Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG 2-4).
  • Severe comorbidities (ACCI >= 4)

Treatment and study plan

Delayed interval cytoreductive surgery (DICS)

Procedure

patients will receive six courses of intravenous carboplatin and paclitaxel every 3 weeks, followed by delayed interval cytoreductive surgery (DICS) within 6 weeks of the last cycle of chemotherapy. After DICS, patients will be assessed for the need or not for further adjuvant chemotherapy.

chemotherapy regimen:

  • Paclitaxel at 175 mg/m² + carboplatin area under the curve (AUC) 5-6 every 3 weeks.
  • Paclitaxel at 60 mg/m² (days 1, 8, and 15), and carboplatin AUC 2 (days 1, 8, and 15) every 3 weeks.
  • Paclitaxel at dense dose 80 mg/m² (days 1, 8, and 15) and carboplatin AUC 5-6 (day 1) every 3 weeks.

Early interval cytoreductive surgery (EICS)

Procedure

patients will receive three courses of intravenous carboplatin and paclitaxel every 3 weeks, followed by early interval cytoreductive surgery (EICS) within 6 weeks of the last cycle of chemotherapy. After EICS, patients will receive adjuvant three courses of intravenous carboplatin and paclitaxel every 3 weeks, then will be assessed for the need or not for further adjuvant chemotherapy.

chemotherapy regimen:

  • Paclitaxel at 175 mg/m² + carboplatin area under the curve (AUC) 5-6 every 3 weeks.
  • Paclitaxel at 60 mg/m² (days 1, 8, and 15), and carboplatin AUC 2 (days 1, 8, and 15) every 3 weeks.
  • Paclitaxel at dense dose 80 mg/m² (days 1, 8, and 15) and carboplatin AUC 5-6 (day 1) every 3 weeks.

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: up to 5years

    PFS will be defined as the time to recurrence/progression, or the date of death. Disease recurrence/ progression is defined as an increase in cancer antigen 125 (CA 125) levels or evidence of recurrence by imaging and/or histology.

  2. Overall survival (OS)

    Time frame: up to 5 years

    OS will be defined as the time until the patient's death from any cause. The time to event occurrence will be calculated from the time of randomization until the event of interest.

Secondary outcomes

  1. Operative peritoneal cancer index (PCI) assessment

    Time frame: 3-6 months

    pre- and post-operative PCI

  2. Complete resection rate

    Time frame: 3-6 months

    proportion of patients without macroscopically visible disease according to residual (R), patients will have R0 if no macroscopic residual, R1 if the residual is ≤10 mm, and R2 if the residual is > 10 mm.

  3. Surgical complexity scoring (low, intermediate, or high)

    Time frame: 3-6 months

    assessment of complexity score of during surgery

  4. Post-operative morbidity

    Time frame: within 30 days of surgery

    Post-operative morbidity according to the Clavien-Dindo classification (CDC), i.e., proportion of severe complications (CDC grade 3-5) within 30 days of surgery.

  5. Pathological complete chemotherapy response score (CRS 3)

    Time frame: 3-6 months

    Pathological complete chemotherapy response score (CRS 3) in the pathology specimen

  6. The total number of chemotherapy cycles administered

    Time frame: 8 months

    The total number of chemotherapy cycles administered (NACT + adjuvant cycles).

  7. Tumour recurrence and death

    Time frame: Up to 5 years

    Proportion of patients who had recurrence or died in each group.

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Elzarkaa, PhD

CONTACT

[email protected]

00201008296264

Hayat Sharaf, MsC

CONTACT

[email protected]

00201025774942

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer: A Randomized Clinical Trial for Early Versus Delayed Interval Cytoreductive Surgery

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
May 8, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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