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

• ClinicalTrials.gov Identifier: NCT01611766
• Recruitment Status: Unknown
• First Posted: June 5, 2012
• Last Update Posted: June 10, 2021
• Sponsor: Shanghai Gynecologic Oncology Group
• 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: May 30, 2012
• First Posted Date: June 5, 2012
• Last Update Posted Date: June 10, 2021
• Actual Study Start Date: July 19, 2012
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: June 4, 2012): overall survival [ Time Frame: Up to 36 months after last patient randomized ]

Current Secondary Outcome Measures (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 (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: Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Ovarian Epithelial Cancer Recurrent
• Fallopian Tube Carcinoma
• Primary Peritoneal Carcinoma

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 24, 2018): 356
• Original Estimated Enrollment (submitted: June 4, 2012): 420
• Estimated Study Completion Date: December 2022
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01611766
• Other Study ID Numbers: SGOG OV 2; SGOG OV2 ( Other Identifier: SGOG )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Shanghai Gynecologic Oncology Group
• Original Responsible Party: Same as current
• Current Study Sponsor: Shanghai Gynecologic Oncology Group
• Original Study Sponsor: Same as current

Collaborators

• Fudan University
• Zhejiang Cancer Hospital
• Shanghai Zhongshan Hospital
• Sun Yat-sen University

Investigators

• Principal Investigator: Rongyu Zang, MD,PhD; Shanghai Gynecologic Oncology Group

• PRS Account: Shanghai Gynecologic Oncology Group
• Verification Date: June 2021