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

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ClinicalTrials.gov Identifier: NCT01611766
Recruitment Status : Active, not recruiting
First Posted : June 5, 2012
Last Update Posted : June 10, 2021
Sponsor:
Collaborators:
Fudan University
Zhejiang Cancer Hospital
Shanghai Zhongshan Hospital
Sun Yat-sen University
Information provided by (Responsible Party):
Shanghai Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE May 30, 2012
First Posted Date  ICMJE June 5, 2012
Last Update Posted Date June 10, 2021
Actual Study Start Date  ICMJE July 19, 2012
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2019)
  • Overall survival [ Time Frame: Up to 60 months after last patient randomized ]
    from date of randomisation until death
  • Progression-free survival [ Time Frame: Up to 24 months after last patient randomized ]
    interval between date of randomization and the date of second relapse/ progression or death, whatever occurs first
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2012)
Overall survival [ Time Frame: Up to 36 months after last patient randomized ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2021)
  • Accumulating Treatment-free survival (TFSa) [ Time Frame: Up to 60 months after last patient randomized ]
    the time of OS minus each treatment period after randomization, including surgery and chemotherapy
  • Overall survival after the adjustment of one-way treatment switching [ Time Frame: Up to 60 months after last patient randomized ]
    OS adjusted by statistical models for crossover
  • 30-day post-operative complications [ Time Frame: From the operation until after 30 days ]
    MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications
  • Validation of iMODEL [ Time Frame: From randomization to operation ]
    iMODEL score to predict complete resection
  • Patient compliance [ Time Frame: Up to 60 months after last patient randomized ]
    compliance with protocol
  • Quality of life assessments [ Time Frame: Study entry; 6 months; 12 months; 24 months and 60 months after randomization ]
    The EORTC core quality of life questionnaire (QLQ-C30, version 3.0) Functional Assessment of Cancer Therapy- Ovary (FACT-O)
  • Time to first subsequent anticancer therapy [ Time Frame: Up to 60 months after last patient randomized ]
    From date of randomization until the date of first recurrent anticancer therapy
  • Time to second subsequent anticancer therapy [ Time Frame: Up to 60 months after last patient randomized ]
    From date of randomization until the date of secondary recurrent anticancer therapy
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2012)
  • 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 120 months. ]
  • Quality of Life [ Time Frame: Baseline, 6, 12, and 24 months after randomization ]
  • Complications incidence [ Time Frame: From the operation until after 60 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?
Official Title  ICMJE Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial
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.
Detailed Description 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Epithelial Cancer Recurrent
  • Fallopian Tube Carcinoma
  • Primary Peritoneal Carcinoma
Intervention  ICMJE
  • Procedure: Secondary Cytoreductive Surgery
    Complete Cytoreduction
    Other Name: Maximum effort cytoreductive surgery
  • Drug: Salvage Chemotherapy
    6 cycles of postoperative chemotherapy
    Other Name: second line chemotherapy
Study Arms  ICMJE
  • Experimental: secondary cytoreductive surgery
    SCR followed by chemotherapy
    Interventions:
    • Procedure: Secondary Cytoreductive Surgery
    • Drug: Salvage Chemotherapy
  • Active Comparator: Salvage Chemotherapy
    platinum-based chemotherapy
    Intervention: Drug: Salvage Chemotherapy
Publications * Shi 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 24, 2018)
356
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2012)
420
Estimated Study Completion Date  ICMJE December 2022
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01611766
Other Study ID Numbers  ICMJE SGOG OV 2
SGOG OV2 ( Other Identifier: SGOG )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shanghai Gynecologic Oncology Group
Study Sponsor  ICMJE Shanghai Gynecologic Oncology Group
Collaborators  ICMJE
  • Fudan University
  • Zhejiang Cancer Hospital
  • Shanghai Zhongshan Hospital
  • Sun Yat-sen University
Investigators  ICMJE
Principal Investigator: Rongyu Zang, MD,PhD Shanghai Gynecologic Oncology Group
PRS Account Shanghai Gynecologic Oncology Group
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP