A randomized controlled multicenter phase III trial comparing cytoreductive surgery followed by intravenous chemotherapy versus intravenous chemotherapy alone for recurrent platinum-sensitive ovarian cancer

A randomized controlled multicenter phase III trial comparing cytoreductive surgery followed by intravenous chemotherapy versus intravenous chemotherapy alone for recurrent platinum-sensitive ovarian cancer - Surgery for Ovarian Cancer Recurrence (SOCceR)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35952

Enrollment

230

Registered

2012-01-26

Start date

2012-07-16

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer of the ovaries ovarian cancer

Interventions

Control arm: intravenous platinum containing chemotherapy Experimental arm: secondary cytoreductive surgery followed by intravenous platinum containing chemotherapy

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age >= 18 years • First recurrence of histologically or cytologically proven epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer of FIGO stage Ic-IV (FIGO system 1988) • First-line treatment consisted of complete or optimal ( 3.0 x 10*/L, platelets > 100 x 10*/L, serum creatinine

Exclusion criteria

Exclusion criteria: • Participation in interfering trial • Non-epithelial or borderline ovarian tumours • Other primary malignancy except for carcinoma in situ and basal or squamous cell carcinoma of the skin • Patients with platinum-refractory or resistant tumours • Intra-abdominal metastatic disease that hampers complete cytoreduction • Extra-abdominal metastatic disease that hampers complete cytoreduction • Palliative surgery already planned (e.g. bowel surgery) • Patients with secondary, third and later recurrence • Any disease, medical history or medication not allowing surgery and/or platinum based chemotherapy • Prior therapy with respect to recurrence

Design outcomes

Primary

Measure	Time frame
Comparing progression free survival (defined as the interval between date of randomization and progressive disease or death of any cause) in the two study-arms	—

Secondary

Measure	Time frame
Comparing overall survival (defined as the interval between date of randomization and date of death), quality of life, morbidity, mortality, toxicity and tumour response following treatment in the two arms. With respect to secondary cytoreductive surgery : determining the effect of complete and incomplete surgery on progression free survival and overall survival, identifying predictive factors and criteria for patient selection for complete surgery.	—

Measure

Time frame

Comparing overall survival (defined as the interval between date of randomization and date of death), quality of life, morbidity, mortality, toxicity and tumour response following treatment in the two arms. With respect to secondary cytoreductive surgery : determining the effect of complete and incomplete surgery on progression free survival and overall survival, identifying predictive factors and criteria for patient selection for complete surgery.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)