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Recruiting

NCT Number: NCT06292286

Secondary Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer

About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Ka Yu Tse

CONTACT

[email protected]

852-22554265

Ka Yu Tse, MBBS, PhD

PRINCIPAL_INVESTIGATOR

Lesley Lau

CONTACT

852-22554518

About this study

Our study aims to evaluate the complete resection rate at interval cytoreductive surgery for recurrent ovarian cancer patients, and to determine the safety and survival outcomes of this approach.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically diagnosed EOC, fallopian tube or primary peritoneal carcinoma
  • >= 3 cycles of platinum-based chemotherapy, with or without bevacizumab and / or PARPi, at primary setting
  • Platinum-free interval should be >=6 months from the last dose of platinum-based chemotherapy
  • Upfront SCR not feasible
  • Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment.
  • Patients must have adequate bone marrow, renal, hepatic and neurological function within 28 days prior to the start of treatment.

Exclusion criteria

  • Non-epithelial or borderline tumors are excluded
  • Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer, in-situ breast cancer, stage 1a grade 1-2 endometrioid endometrial carcinoma without lymphovascular invasion) are excluded.
  • Patients using more than one line of chemotherapy are excluded.
  • Patients who have platinum-resistant or refractory recurrence are excluded.
  • Patients having second relapse or beyond are excluded.
  • Patients who have contraindications to operation, e.g., unresolved thrombocytopenia, bowel obstruction in the last 4 weeks prior to enrolment

Treatment and study plan

Carboplatin or cisplatin

Procedure

Carboplatin of cisplatin for 3-6 cycles

Other names: Paraplatin or Platinol

Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar

Drug

Paclitaxel, gemcitabine or liposomal doxorubicin, for 3-6 cycles

Other names: Taxol, Gemzar, Caelyx

Bevacizumab or biosimilar

Drug

Optional

Other names: Avastin or mvasi

cytoreductive surgery

Procedure

Cytoreductive surgery after chemotherapy

Primary outcomes

  1. Complete resection rate

    Time frame: 12 months

    Rate of complete resection at the time of operation

Secondary outcomes

  1. 12-month progression-free survival rate

    Time frame: 12 months

    The time from the first dose of chemotherapy to the first documentation of objective tumor progression (PD) or to death due to any cause, whichever occurs first.

  2. 12-month overall survival rate

    Time frame: 12 months

    Overall survival is defined as the time from the first dose of chemotherapy to the date of death due to any cause.

  3. Surgical complication rate

    Time frame: 12 months

    Complications are graded by the Clavien-Dindo classification

  4. Quality of life scale

    Time frame: 12 months

    Different functional scales will be assessed by questionnaires like the EORTC questionnaires where all scales range from 0-100. The higher the score, the greater the intensity of that particular item is.

Study contacts

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

Lesley Lau

CONTACT

[email protected]

852-22554265

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Secondary Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer Patients - a Pilot Study

Acronym: SCENIC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2024
Registry last updated
Jun 11, 2025

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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