Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Docetaxel

Albumin-Bound Paclitaxel

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.

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

Upfront cytoreductive 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

Interval debulking surgery

Rong Jiang, MD

Yuting Luan, RN

Jihong Liu, MD,PhD

Rongyu Zang, MD,PhD

Xipeng Wang, MD,PhD

Jianqing Zhu, MD

Ding Zhu, MD

MyungHee Nam, RN

JinHee Kim, BSN

Rongyu Zang, MD,PHD

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

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

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

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

The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first.

The surgical complications will be evaluated at 30-day after upfront cytoreductive surgery or interval debulking surgery.

QOQ-C30,FACT-O( baseline; 6months, 12 months and 5 years after randomization)

The overall survival time minus the total treatment time of surgery and chemotherapy after randomization, but maintenance of targeted agents is considered off-treatment.

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.

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 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 the patients without progression or recurrence or death at 5 years.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Upfront Surgery Versus Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer (SUNNY)	NCT02859038	Epithelial Ovar... Fallopian Tube ... Primary Periton...	Upfront cytored... Interval debulk...	18 Years -	Shanghai Gynecologic Oncology Group
Study of Upfront Surgery Versus Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer (SUNNY)	NCT02859038	Epithelial Ovar... Fallopian Tube ... Primary Periton...	Upfront cytored... Interval debulk...	18 Years -	Shanghai Gynecologic Oncology Group

Spots Global Cancer Trial Database for upfront cytoreductive surgery