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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Carboplatin or cisplatin

    Procedure/Surgery

    Carboplatin of cisplatin for 3-6 cycles

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

    Drug

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

  • Bevacizumab or biosimilar

    Drug

    Optional

  • Cytoreductive surgery

    Procedure/Surgery

    Cytoreductive surgery after chemotherapy

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Chemotherapy and surgery armExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Complete resection rate

Rate of complete resection at the time of operation

Time frame
12 months

Secondary outcomes

1

12-month progression-free survival rate

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.

Time frame
12 months
2

12-month overall survival rate

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

Time frame
12 months
3

Surgical complication rate

Complications are graded by the Clavien-Dindo classification

Time frame
12 months
4

Quality of life scale

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

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