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

June 7, 2021 updated by: Shanghai Gynecologic Oncology Group

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

356

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Cancer Hospital
      • Shanghai, Shanghai, China, 200032
        • Shanghai Zhongshan Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to 60 months after last patient randomized
from date of randomisation until death
Up to 60 months after last patient randomized
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
Up to 24 months after last patient randomized

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 60 months after last patient randomized
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
Up to 60 months after last patient randomized
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
From the operation until after 30 days
Validation of iMODEL
Time Frame: From randomization to operation
iMODEL score to predict complete resection
From randomization to operation
Patient compliance
Time Frame: Up to 60 months after last patient randomized
compliance with protocol
Up to 60 months after last patient randomized
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)
Study entry; 6 months; 12 months; 24 months and 60 months after randomization
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
Up to 60 months after last patient randomized
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
Up to 60 months after last patient randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Gynecologic Oncology Group

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2012

Primary Completion (Actual)

December 1, 2019

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

May 30, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 5, 2012

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGOG OV 2
  • SGOG OV2 (Other Identifier: SGOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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