Clinical trial · Interventional
Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?
Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial
NCT01611766CI-TRIAL-00052215unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Epithelial Cancer Recurrent | — | UNRESOLVED | — |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Salvage Chemotherapy | Drug | — | UNRESOLVED |
| Secondary Cytoreductive Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- secondary cytoreductive surgery
- description
- SCR followed by chemotherapy
- interventionNames
- Procedure: Secondary Cytoreductive Surgery
- Drug: Salvage Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Salvage Chemotherapy
- description
- platinum-based chemotherapy
- interventionNames
- Drug: Salvage Chemotherapy
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- Up to 60 months after last patient randomized
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 1. Accompanied by hypoxia serious chronic obstructive pulmonary disease 2. Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine. 3. Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency 4. Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy. 5. Uncontrolled diabetes 6. 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.
References
Publications (2)
- DERIVEDJiang R, Feng Y, Chen Y, Cheng X, Shi T, Gao W, Jia H, Jiang S, Guo Y, Huang X, Tu D, Zhang Y, Yang H, Zhang P, Liu J, Zhu J, Zang R; SOC-1 Investigators. Surgery versus no surgery in platinum-sensitive relapsed ovarian cancer: final overall survival analysis of the SOC-1 randomized phase 3 trial. Nat Med. 2024 Aug;30(8):2181-2188. doi: 10.1038/s41591-024-02981-0. Epub 2024 Jun 1. PMID 38824243
- DERIVEDShi T, Zhu J, Feng Y, Tu D, Zhang Y, Zhang P, Jia H, Huang X, Cai Y, Yin S, Jiang R, Tian W, Gao W, Liu J, Yang H, Cheng X, Zang R. Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):439-449. doi: 10.1016/S1470-2045(21)00006-1. Epub 2021 Mar 8. PMID 33705695