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

Primary Purpose

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Upfront cytoreductive surgery
Interval debulking surgery
Sponsored by
Shanghai Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Yet-Sen University Cancer CenterRecruiting
  • Zhongshan Hospital Fudan UniversityRecruiting
  • Shanghai First Maternity and Infant Hospital Affiliated to Tongji University
  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Zhejiang Cancer HospitalRecruiting
  • Hunan Provincial Hospital
  • Seoul National University HospitalRecruiting
  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Upfront cytoreductive surgery

Neoadjuvant chemotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall survival
The time from entry into the study to any cause of death.

Secondary Outcome Measures

Progression-free survival
The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first.
Post-operative complications
The surgical complications will be evaluated at 30-day after upfront cytoreductive surgery or interval debulking surgery.
Quality of life assessments
QOQ-C30,FACT-O( baseline; 6months, 12 months and 5 years after randomization)
Accumulated treatment-free survival (TFSa)
The overall survival time minus the total treatment time of surgery and chemotherapy after randomization, but maintenance of targeted agents is considered off-treatment.
Time to first subsequent anticancer therapy (TFST)
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.
Time to second subsequent anticancer therapy (TSST)
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.
The pattern of the first relapse
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.
The rate of 5-year progression-free survival
The rate of the patients without progression or recurrence or death at 5 years.
Outcomes of pulmonary embolism
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.

Full Information

First Posted
July 23, 2016
Last Updated
October 8, 2021
Sponsor
Shanghai Gynecologic Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT02859038
Brief Title
Study of Upfront Surgery Versus Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer (SUNNY)
Official Title
Study of Upfront Surgery Versus Neoadjuvant Chemotherapy Followed by Interval Debulking Surgery for Patients With Stage IIIC and IV Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Gynecologic Oncology Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
488 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Upfront cytoreductive surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
Neoadjuvant chemotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Upfront cytoreductive surgery
Other Intervention Name(s)
Primary debulking surgery, PDS
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Interval debulking surgery
Other Intervention Name(s)
NACT-IDS
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall survival
Description
The time from entry into the study to any cause of death.
Time Frame
Participants will be followed for at least 5 years after randomization or until death
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first.
Time Frame
Participants will be followed for at least 5 years after randomization or until death
Title
Post-operative complications
Description
The surgical complications will be evaluated at 30-day after upfront cytoreductive surgery or interval debulking surgery.
Time Frame
Participants will be followed up to 6 months after randomization
Title
Quality of life assessments
Description
QOQ-C30,FACT-O( baseline; 6months, 12 months and 5 years after randomization)
Time Frame
Participants will be followed for at least 5 years after randomization or until death
Title
Accumulated treatment-free survival (TFSa)
Description
The overall survival time minus the total treatment time of surgery and chemotherapy after randomization, but maintenance of targeted agents is considered off-treatment.
Time Frame
Participants will be followed for at least 5 years after randomization or until death
Title
Time to first subsequent anticancer therapy (TFST)
Description
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.
Time Frame
Participants will be followed for at least 5 years after randomization or until death
Title
Time to second subsequent anticancer therapy (TSST)
Description
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.
Time Frame
Participants will be followed for at least 5 years after randomization or until death
Title
The pattern of the first relapse
Description
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.
Time Frame
Participants will be followed for at least 5 years after randomization or until death
Title
The rate of 5-year progression-free survival
Description
The rate of the patients without progression or recurrence or death at 5 years.
Time Frame
Participants will be followed for at least 5 years after randomization or until death
Title
Outcomes of pulmonary embolism
Description
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.
Time Frame
Participants will be followed for at least 5 years after randomization or until death

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women aged ≥ 18 years. 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. ECOG performance status of 0 to 2. ASA score of 1 to 2. Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery: white blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL, 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, serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL. Comply with the study protocol and follow-up. Written informed consent. Exclusion Criteria: Patients with non-epithelial tumors as well as borderline tumors. Mucinous ovarian cancer. Low grade ovarian cancer. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol. Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Jiang, MD
Phone
86 21 64041990
Email
jiang.rong@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yuting Luan, RN
Phone
86 21 64041990
Email
yutingluan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongyu Zang, MD,PHD
Organizational Affiliation
Fudan University Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yet-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihong Liu, MD,PhD
Phone
86 20 87343392
Email
liujih@mail.sysu.edu.cn
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Jiang, MD
Phone
86 21 64041990
Email
jiang.rong@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Yuting Luan, RN
Phone
86 21 64041990
Email
yutingluan@163.com
First Name & Middle Initial & Last Name & Degree
Rongyu Zang, MD,PhD
Facility Name
Shanghai First Maternity and Infant Hospital Affiliated to Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xipeng Wang, MD,PhD
Phone
86 21 20261000
Facility Name
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xipeng Wang, MD,PhD
Phone
86 21 25078999
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianqing Zhu, MD
Phone
86 571 8822222
Email
zjq-hz@126.com
Facility Name
Hunan Provincial Hospital
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ding Zhu, MD
Phone
86 731 83929342
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MyungHee Nam, RN
Phone
82 220721922
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JinHee Kim, BSN
Email
koreagynonco@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32808504
Citation
Jiang R, Zhu J, Kim JW, Liu J, Kato K, Kim HS, Zhang Y, Zhang P, Zhu T, Aoki D, Yu A, Chen X, Wang X, Zhu D, Zhang W, Jia H, Shi T, Gao W, Yin S, Feng Y, Xiang L, Okamoto A, Zang R. Study of upfront surgery versus neoadjuvant chemotherapy followed by interval debulking surgery for patients with stage IIIC and IV ovarian cancer, SGOG SUNNY (SOC-2) trial concept. J Gynecol Oncol. 2020 Sep;31(5):e86. doi: 10.3802/jgo.2020.31.e86.
Results Reference
derived
Links:
URL
http://www.ShanghaiGOG.org
Description
Shanghai Gynecologic Oncology Group

Learn more about this trial

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

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