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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||456 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Overall survival [ Time Frame: Participants will be followed for at least 5 years after randomization ]
- Progression-free survival [ Time Frame: Participants will be followed for at least 2 years after randomization ]
- 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.
- 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)
- 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…
- 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
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
|Contact: Rong Jiang, MD||86 21 firstname.lastname@example.org|
|Contact: Yuting Luan, RN||86 21 email@example.com|
|Sun Yet-Sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Jihong Liu, MD,PhD 86 20 87343392 firstname.lastname@example.org|
|Zhongshan Hospital Fudan University||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Rong Jiang, MD 86 21 64041990 email@example.com|
|Contact: Yuting Luan, RN 86 21 64041990 firstname.lastname@example.org|
|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|
|Zhejiang Cancer Hospital||Recruiting|
|Hangzhou, Zhejiang, China, 310022|
|Contact: Jianqing Zhu, MD 86 571 8822222 email@example.com|
|Hunan Provincial Hospital||Not yet recruiting|
|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 firstname.lastname@example.org|
|Principal Investigator:||Rongyu Zang, MD,PHD||Fudan University Shanghai Zhongshan Hospital|