Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and validate the risk model of patient selection criteria in platinum-sensitive recurrent ovarian cancer.

Detailed Description
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The primary objective is to determine whether secondary cytoreduction followed by chemotherapy is superior to chemotherapy alone in improving progression-free survival (PFS) and overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer

Official Title
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Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial

Conditions
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Ovarian Epithelial Cancer Recurrent, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

Intervention / Treatment
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* Procedure: Secondary Cytoreductive Surgery
* Drug: Salvage Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at recurrence ≥ 18 years Patients with platinum-sensitive, first relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC, PPC, FTC), which is defined as those with treatment -free interval of 6 months or more. A complete secondary cytoreduction predicting score, iMODEL [Tian WJ, Ann Surg Oncol 2012,19(2):597-604]<=4.7, including FIGO stage (0 or 0.8); residual disease after primary surgery (0 or 1.5); Progression-free interval (0 or 2.4); PS ECOG (0 or 2.4); Ca125 (0 or 1.8); and ascites at recurrence (0 or 3.0). If PI and CO-PI reach consensus that the recurrent tumor detected by PET/CT could be completely resected, the index of CA125 could be scored as 0. (Revised on 09/30/2013) Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. If single lesion outside the peritoneal cavity can be resected, MRI/CT or PET/CT scan should be performed to exclude simultaneous intra-abdominal lesions. Patients who have given their signed and written informed consent and their consent. Exclusion Criteria: Patients with borderline tumors as well as non-epithelial tumors. Patients for interval-debulking, or for second-look surgery, or palliative surgery planned. Impossible to assess the resectability or evaluate the score. Radiological signs suggesting complete resection is impossible. More than one prior chemotherapy. Second relapse or more Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected. Progression during chemotherapy or recurrence within 6 months after first-line therapy Any contradiction not allowing surgery and/or chemotherapy Accompanied by hypoxia serious chronic obstructive pulmonary disease Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine. Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy. Uncontrolled diabetes Uncontrolled epilepsy need long-term antiepileptic treatment. Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents, or bevacizumab.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: secondary cytoreductive surgery<br>SCR followed by chemotherapy | Procedure: Secondary Cytoreductive Surgery<br>* Complete Cytoreduction<br>* Other names: Maximum effort cytoreductive surgery;Drug: Salvage Chemotherapy<br>* 6 cycles of postoperative chemotherapy<br>* Other names: second line chemotherapy;|
| Active Comparator: Salvage Chemotherapy<br>platinum-based chemotherapy | Drug: Salvage Chemotherapy<br>* 6 cycles of postoperative chemotherapy<br>* Other names: second line chemotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | from date of randomisation until death | Up to 60 months after last patient randomized | 
| Progression-free survival | interval between date of randomization and the date of second relapse/ progression or death, whatever occurs first | Up to 24 months after last patient randomized | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulating Treatment-free survival (TFSa) | the time of OS minus each treatment period after randomization, including surgery and chemotherapy | Up to 60 months after last patient randomized | 
| Overall survival after the adjustment of one-way treatment switching | OS adjusted by statistical models for crossover | Up to 60 months after last patient randomized | 
| 30-day post-operative complications | MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications | From the operation until after 30 days | 
| Validation of iMODEL | iMODEL score to predict complete resection | From randomization to operation | 
| Patient compliance | compliance with protocol | Up to 60 months after last patient randomized | 
| Quality of life assessments | The EORTC core quality of life questionnaire (QLQ-C30, version 3.0) Functional Assessment of Cancer Therapy- Ovary (FACT-O) | Study entry; 6 months; 12 months; 24 months and 60 months after randomization | 
| Time to first subsequent anticancer therapy | From date of randomization until the date of first recurrent anticancer therapy | Up to 60 months after last patient randomized | 
| Time to second subsequent anticancer therapy | From date of randomization until the date of secondary recurrent anticancer therapy | Up to 60 months after last patient randomized | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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secondary cytoreductive surgery, Ovarian Cancer, surgery, recurrence