Clinical trial NCT02859038: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Lead sponsor: Shanghai Gynecologic Oncology Group
Sponsor class: OTHER_GOV
First posted: 2016-08-08
Enrollment: 489
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Overall survival
timeFrame: Participants will be followed for at least 5 years after randomization or until death
Secondary outcomes:
measure: Progression-free survival
timeFrame: Participants will be followed for at least 5 years after randomization or until death
measure: Post-operative complications
timeFrame: Participants will be followed up to 6 months after randomization
measure: Quality of life assessments
timeFrame: Participants will be followed for at least 5 years after randomization or until death
measure: Accumulated treatment-free survival (TFSa)
timeFrame: Participants will be followed for at least 5 years after randomization or until death
measure: Time to first subsequent anticancer therapy (TFST)
timeFrame: Participants will be followed for at least 5 years after randomization or until death
measure: Time to second subsequent anticancer therapy (TSST)
timeFrame: Participants will be followed for at least 5 years after randomization or until death
measure: The pattern of the first relapse
timeFrame: Participants will be followed for at least 5 years after randomization or until death
measure: The rate of 5-year progression-free survival
timeFrame: Participants will be followed for at least 5 years after randomization or until death
measure: Outcomes of pulmonary embolism
timeFrame: Participants will be followed for at least 5 years after randomization or until death
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yet-Sen University Cancer Center
state: Guangdong
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital Affiliated to Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Changsha
country: China
facility: Hunan Provincial Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Fudan University Shanghai Zhongshan Hospital
name: Rongyu Zang, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.