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

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ClinicalTrials.gov Identifier: NCT01611766
Recruitment Status : Recruiting
First Posted : June 5, 2012
Last Update Posted : May 18, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Epithelial Cancer Recurrent Fallopian Tube Carcinoma Primary Peritoneal Carcinoma Procedure: Secondary Cytoreductive Surgery Drug: Salvage Chemotherapy Phase 3

Detailed Description:
The primary objective of this study is to compare overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer with a positive SCR score randomized to secondary cytoreductive surgery followed by chemotherapy versus chemotherapy alone.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial
Study Start Date : January 2011
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : December 2021

Arms and Interventions

Arm Intervention/treatment
Experimental: secondary cytoreductive surgery
SCR followed by chemotherapy
Procedure: Secondary Cytoreductive Surgery
Complete Cytoreduction
Other Name: Debulking Surgery
Drug: Salvage Chemotherapy
Active Comparator: Salvage Chemotherapy
platinum-based chemotherapy
Drug: Salvage Chemotherapy

Outcome Measures

Primary Outcome Measures :
  1. overall survival [ Time Frame: Up to 36 months after last patient randomized ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Progression-free survival is defined as interval between date of randomization and 2nd relapse/progression or death (whatever occurs first), assessed up to 36 months. ]
  2. Quality of Life [ Time Frame: Baseline, 6, 12, and 24 months after randomization ]
  3. complications incidence [ Time Frame: From the operation until after 60 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).
  • 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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611766

Contact: Xiao Huang, MD, PhD +862164175590 smilehuangxiao@163.com
Contact: Yuting Luan, RN +862164175590 fudanGOG@gmail.com; yutingluan@163.com

China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jihong Jiu, MD, PhD    86 20 87343088    liujih@mail.sysu.edu.cn   
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiao Huang, MD,PhD    +862164175590    smilehuangxiao@163.com   
Principal Investigator: Rongyu Zang, MD,PhD         
Shanghai Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Rong Jiang, MD    86 21 64041990 ext 2905    rong_junzhu@aliyun.com   
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Jianqing Zhu, MD    86 571 8822222    zjq-hz@126.com   
Sponsors and Collaborators
Shanghai Gynecologic Oncology Group
Fudan University
Zhejiang Cancer Hospital
Shanghai Zhongshan Hospital
Sun Yat-sen University
Principal Investigator: Rongyu Zang, MD,PhD Shanghai Gynecologic Oncology Group
More Information

Additional Information:
Responsible Party: Shanghai Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01611766     History of Changes
Other Study ID Numbers: V02_2010_10
SGOG OV2 ( Other Identifier: SGOG )
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: July 2016

Keywords provided by Shanghai Gynecologic Oncology Group:
secondary cytoreductive surgery
Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Fallopian Tube Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases