Study of Upfront Surgery Versus Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer (SUNNY)

October 8, 2021 updated by: Shanghai Gynecologic Oncology Group

Study of Upfront Surgery Versus Neoadjuvant Chemotherapy Followed by Interval Debulking Surgery for Patients With Stage IIIC and IV Ovarian Cancer

The purpose of this study is to answer the fundamental question, should the physicians choose Surgery or Chemotherapy (SOC-2) in advanced ovarian cancer?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: Compare the efficacy and safety in patients with AJCC TNM stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer, or peritoneal carcinoma treated with neoadjuvant chemotherapy followed by interval debulking surgery versus upfront surgery.

OUTLINE: This is a randomized phase III multicenter study. Patients will receive upfront maximal cytoreductive surgery followed by at least 6 cycles of adjuvant chemotherapy or 3 cycles of neoadjuvant chemotherapy followed by interval debulking surgery, and then at least 3 cycles of adjuvant chemotherapy.

Patients are followed every 3 months within the first 5 years, and then every 6 months.

PROJECTED ACCRUAL: A total of 488 patients will be accrued for this study within 5 years.

Study Type

Interventional

Enrollment (Anticipated)

488

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 Contact

Study Contact Backup

Study Locations

  • China
      • Changsha, China
        • Not yet recruiting
        • Hunan Provincial Hospital
        • Contact:
          • Ding Zhu, MD
          • Phone Number: 86 731 83929342
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yet-sen University Cancer Center
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital Fudan University
        • Principal Investigator:
          • Rongyu Zang, MD,PhD
        • Contact:
        • Contact:
      • Shanghai, Shanghai, China, 200040
        • Not yet recruiting
        • Shanghai First Maternity and Infant Hospital Affiliated to Tongji University
        • Contact:
          • Xipeng Wang, MD,PhD
          • Phone Number: 86 21 20261000
      • Shanghai, Shanghai, China, 200092
        • Not yet recruiting
        • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Xipeng Wang, MD,PhD
          • Phone Number: 86 21 25078999
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • MyungHee Nam, RN
          • Phone Number: 82 220721922
      • Suwon, Korea, Republic of

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women aged ≥ 18 years.

  2. Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (diagnosis by biopsy or fine needle aspiration*). Laparoscopic biopsy with pictures is recommended.

    * If fine needle aspiration showing an adenocarcinoma, patients should satisfy the following conditions: a. the patient has a pelvic mass, and b. omental cake or other metastasis larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis, and c. serum CA125/CEA ratio>25. If serum CA125/CEA ratio<25 or malignancies of other origins, such as breasts and digestive tract, are suspected from symptoms, physical examinations or imaging diagnosis, endoscopy or ultrasonography should be done to exclusive metastasis ovarian cancer.

  3. ECOG performance status of 0 to 2.
  4. ASA score of 1 to 2.

  5. Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:

    1. white blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
    2. serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,
    3. serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.
  6. Comply with the study protocol and follow-up.
  7. Written informed consent.

Exclusion Criteria:

  1. Patients with non-epithelial tumors as well as borderline tumors.
  2. Mucinous ovarian cancer.
  3. Low grade ovarian cancer.
  4. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
  5. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
  6. Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.

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: Upfront cytoreductive surgery
Upfront cytoreductive surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy.
Procedure: Upfront cytoreductive surgery
Upfront cytoreductive surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5
Other Names:
  • Primary debulking surgery, PDS
Active Comparator: Neoadjuvant chemotherapy
neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy.
Procedure: Interval debulking surgery
3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy
Other Names:
  • NACT-IDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Participants will be followed for at least 5 years after randomization or until death
The time from entry into the study to any cause of death.
Participants will be followed for at least 5 years after randomization or until death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Participants will be followed for at least 5 years after randomization or until death
The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first.
Participants will be followed for at least 5 years after randomization or until death
Post-operative complications
Time Frame: Participants will be followed up to 6 months after randomization
The surgical complications will be evaluated at 30-day after upfront cytoreductive surgery or interval debulking surgery.
Participants will be followed up to 6 months after randomization
Quality of life assessments
Time Frame: Participants will be followed for at least 5 years after randomization or until death
QOQ-C30,FACT-O( baseline; 6months, 12 months and 5 years after randomization)
Participants will be followed for at least 5 years after randomization or until death
Accumulated treatment-free survival (TFSa)
Time Frame: Participants will be followed for at least 5 years after randomization or until death
The overall survival time minus the total treatment time of surgery and chemotherapy after randomization, but maintenance of targeted agents is considered off-treatment.
Participants will be followed for at least 5 years after randomization or until death
Time to first subsequent anticancer therapy (TFST)
Time Frame: Participants will be followed for at least 5 years after randomization or until death
The date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurs first. Maintenance treatments following a cytostatic treatment are NOT considered separate treatment lines.
Participants will be followed for at least 5 years after randomization or until death
Time to second subsequent anticancer therapy (TSST)
Time Frame: Participants will be followed for at least 5 years after randomization or until death
The date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurs first. Maintenance treatments following a cytostatic treatment are NOT considered separate treatment lines.
Participants will be followed for at least 5 years after randomization or until death
The pattern of the first relapse
Time Frame: Participants will be followed for at least 5 years after randomization or until death
The number and sites of the first relapse, including pelvic, abdominal, retroperitoneal lymph nodes, distant metastases and ascites will be compared between the two groups.
Participants will be followed for at least 5 years after randomization or until death
The rate of 5-year progression-free survival
Time Frame: Participants will be followed for at least 5 years after randomization or until death
The rate of the patients without progression or recurrence or death at 5 years.
Participants will be followed for at least 5 years after randomization or until death
Outcomes of pulmonary embolism
Time Frame: Participants will be followed for at least 5 years after randomization or until death
The incidence of pulmonary embolism prior to primary treatment in the ITT and hospital populations. Its effect on survival between groups in the ITT and hospital populations.
Participants will be followed for at least 5 years after randomization or until death

Collaborators and Investigators

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

Sponsor

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

August 1, 2016

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

July 23, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGOG OV4B
  • SOC-2 (Other Identifier: Shanghai Gynecologic Oncology Group)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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