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

February 27, 2024 updated by: Dr. Ka-Yu Tse, The University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lesley Lau
  • Phone Number: 852-22554265
  • Email: lsk382@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The University of Hong Kong
        • Contact:
          • Lesley Lau
          • Phone Number: 852-22554518
        • Contact:
        • Principal Investigator:
          • Ka Yu Tse, MBBS, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemotherapy and surgery arm
Patients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC.
Procedure: Carboplatin or cisplatin
Carboplatin of cisplatin for 3-6 cycles
Other Names:
  • Paraplatin or Platinol
Drug: Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar
Paclitaxel, gemcitabine or liposomal doxorubicin, for 3-6 cycles
Other Names:
  • Taxol, Gemzar, Caelyx
Drug: Bevacizumab or biosimilar
Optional
Other Names:
  • Avastin or mvasi
Procedure: Cytoreductive surgery
Cytoreductive surgery after chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete resection rate
Time Frame: 12 months
Rate of complete resection at the time of operation
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
Surgical complication rate
Time Frame: 12 months
Complications are graded by the Clavien-Dindo classification
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Ka Yu Tse, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Estimated)

March 5, 2024

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 22-704

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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