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

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Enrolling

Conditions

Recurrent Ovarian Carcinoma

Treatments

Procedure: Carboplatin or cisplatin
Drug: Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar
Drug: Bevacizumab or biosimilar
Procedure: Cytoreductive surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06292286
UW 22-704

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Chemotherapy and surgery arm
Experimental group
Description:
Patients receive platinum-based chemotherapy with or without bevacizumab, and then undergo cytoreductive operation, for the first recurrence of EOC.
Treatment:
Drug: Bevacizumab or biosimilar
Procedure: Cytoreductive surgery
Drug: Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar
Procedure: Carboplatin or cisplatin

Trial contacts and locations

1

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Central trial contact

Lesley Lau

Data sourced from clinicaltrials.gov

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