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RESCUE Study (REcurrent Ovarian Cancer Secondary Cytoreduction Using Chemotherapy rEsponse)

ConditionsOvarian Cancer RecurrentPlatinum Sensitive Ovarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age19+
SponsorAsan Medical Center

About this trial

This is a multicenter, prospective, randomized, open-label Phase III clinical trial (RESCUE study) evaluating the efficacy of secondary cytoreductive surgery (SCS) in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have shown a favorable response to 3-4 cycles of platinum-based neoadjuvant chemotherapy and are assessed as highly likely to achieve complete tumor resection based on selection models. Eligible patients will be randomly assigned to either the experimental arm, receiving SCS followed by chemotherapy (with or without maintenance), or the active comparator arm, receiving chemotherapy only (with or without maintenance), with the primary objective being to compare the Progression-Free Survival (PFS) between the two groups to determine the additional clinical benefit of SCS in this carefully selected patient population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

First recurrence of platinum-sensitive, invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer, regardless of initial stage.

A progression-free interval of at least 6 months after the end of the last platinum-containing regimen.

Demonstrated response during neoadjuvant chemotherapy after recurrence (Complete Response/Partial Response/Stable Disease according to RECIST 1.1 or GCIG CA-125 response, which is a ≥50% reduction in pre-treatment CA-125 level sustained for ≥28 days).

Women aged 19 years or older.

Disqualifiers

Patients without recurrence

Patients with non-epithelial tumors or borderline tumors.

Patients with second, third, or subsequent recurrence.

Patients with a secondary malignancy treated with laparotomy and other neoplasms, where the treatment is expected to interfere with the treatment of recurrent ovarian cancer or significantly affect prognosis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Secondary cytoreductive surgery

    Procedure/Surgery

    Secondary Cytoreductive Surgery (SCS) is a surgical procedure performed on patients with relapsed or recurrent epithelial ovarian cancer, after they have completed their initial course of treatment (such as primary surgery and chemotherapy).

  • Platinum Based Chemotherapy

    Drug

    Platinum Based Chemotherapy

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: SurgeryExperimental treatment 2 interventions
Group B: No surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free Survival

The length of time a patient lives with a cancer, without the disease getting worse or death from any cause.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary outcomes

1

Overall Survival

the date of randomization into the study arm until the date of death from any cause

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
2

Complete Resection Rate (R0)

The Complete Resection Rate is the percentage of patients in the surgical arm for whom the surgeon successfully removes all macroscopic (visible) tumor tissue (R0 status).

Time frame
postoperative (up to 2 months after surgery)
3

Surgical Complication Rate

The Surgical Complication Rate measures the frequency and severity of adverse events, such as infections, bleeding, or wound healing problems (graded by Clavien-Dindo classification), experienced by patients in the Secondary Cytoreductive Surgery arm.

Time frame
Postoperative (up to 2 months after surgery)
4

KELIM (The modeled CA-125 ELIMination rate constant K)

The KELIM (The modeled CA-125 ELIMination rate constant K) Score will be evaluated as a secondary endpoint to confirm its prognostic accuracy in predicting the actual surgical outcome (Complete Resection Rate) and the long-term survival (PFS and OS) in the randomized patients.

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asan Medical Center

Lead sponsor

Korean Gynecologic Oncology Group

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: