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

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ClinicalTrials.gov Identifier: NCT02859038
Recruitment Status : Recruiting
First Posted : August 8, 2016
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Gynecologic Oncology Group

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?

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Procedure: Upfront cytoreductive surgery Procedure: Interval debulking surgery Phase 3

Detailed Description:

OBJECTIVES: Compare the efficacy and safety in patients with FIGO (2014) 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 456 patients will be accrued for this study within 5 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Upfront Surgery Versus Neoadjuvant Chemotherapy Followed by Interval Debulking Surgery for Patients With Stage IIIC and IV Ovarian Cancer
Study Start Date : August 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022


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 Name: 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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Participants will be followed for at least 5 years after randomization ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Participants will be followed for at least 2 years after randomization ]
  2. 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.

  3. Quality of life assessments [ Time Frame: Participants will be followed for at least 5 years or death after randomization ]
    QOQ-C30,FACT-O( baseline; 6 and 12 months after randomization)

  4. Treatment-Free Intervals (TFIs) [ Time Frame: Participants will be followed for at least 5 years or death after randomization ]
    It is the total intervals of the ending date from system anticancer therapy to the starting date of the subsequent anticancer therapy or death, such as TFI1+TIF2+TFI3…

  5. The rates of TFI1=0 month and TFI1<6 months, and the rates of TFI2=0 month and TFI2<6 months in S-LPS subgroup [ Time Frame: Participants will be followed up to 2 years after randomization ]
    The rates of TFI1=0 month and TFI1<6 months, and the rates of TFI2=0 month and TFI2<6 months in patients who underwent laparoscopic biopsy compared with those in patients without laparoscopic biopsy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859038


Contacts
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Contact: Rong Jiang, MD 86 21 64041990 jiang.rong@zs-hospital.sh.cn
Contact: Yuting Luan, RN 86 21 64041990 yutingluan@163.com

Locations
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China, Guangdong
Sun Yet-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jihong Liu, MD,PhD    86 20 87343392    liujih@mail.sysu.edu.cn   
China, Shanghai
Zhongshan Hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Rong Jiang, MD    86 21 64041990    jiang.rong@zs-hospital.sh.cn   
Contact: Yuting Luan, RN    86 21 64041990    yutingluan@163.com   
Principal Investigator: Rongyu Zang, MD,PhD         
Shanghai First Maternity and Infant Hospital Affiliated to Tongji University Not yet recruiting
Shanghai, Shanghai, China, 200040
Contact: Xipeng Wang, MD,PhD    86 21 20261000      
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Not yet recruiting
Shanghai, Shanghai, China, 200092
Contact: Xipeng Wang, MD,PhD    86 21 25078999      
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Jianqing Zhu, MD    86 571 8822222    zjq-hz@126.com   
China
Hunan Provincial Hospital Not yet recruiting
Changsha, China
Contact: Ding Zhu, MD    86 731 83929342      
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: MyungHee Nam, RN    82 220721922      
Ajou University Hospital Not yet recruiting
Suwon, Korea, Republic of
Contact: JinHee Kim, BSN       koreagynonco@hanmail.net   
Sponsors and Collaborators
Shanghai Gynecologic Oncology Group
Investigators
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Principal Investigator: Rongyu Zang, MD,PHD Fudan University Shanghai Zhongshan Hospital
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT02859038    
Other Study ID Numbers: SGOG OV4B
SOC 2 ( Other Identifier: Shanghai Gynecologic Oncology Group )
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases