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

Fallopian Tube Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02859038
• Other study ID #: SGOG OV4B
• Secondary ID: SOC-2
• Status: Recruiting
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: June 2023

Study information

• Verified date: October 2021
• Source: Shanghai Gynecologic Oncology Group
• Contact: Rong Jiang, MD
• Phone: 86 21 64041990
• Email: jiang.rong[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 488
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

Intervention

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
• 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

Locations

Country	Name	City	State
China	Hunan Provincial Hospital	Changsha
China	Sun Yet-Sen University Cancer Center	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Shanghai First Maternity and Infant Hospital Affiliated to Tongji University	Shanghai	Shanghai
China	Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Gynecologic Oncology Group

Countries where clinical trial is conducted

China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The time from entry into the study to any cause of death.	Participants will be followed for at least 5 years after randomization or until death
Secondary	Progression-free survival	The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first.	Participants will be followed for at least 5 years after randomization or until death
Secondary	Post-operative complications	The surgical complications will be evaluated at 30-day after upfront cytoreductive surgery or interval debulking surgery.	Participants will be followed up to 6 months after randomization
Secondary	Quality of life assessments	QOQ-C30,FACT-O( baseline; 6months, 12 months and 5 years after randomization)	Participants will be followed for at least 5 years after randomization or until death
Secondary	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.	Participants will be followed for at least 5 years after randomization or until death
Secondary	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.	Participants will be followed for at least 5 years after randomization or until death
Secondary	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.	Participants will be followed for at least 5 years after randomization or until death
Secondary	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.	Participants will be followed for at least 5 years after randomization or until death
Secondary	The rate of 5-year progression-free survival	The rate of the patients without progression or recurrence or death at 5 years.	Participants will be followed for at least 5 years after randomization or until death
Secondary	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.	Participants will be followed for at least 5 years after randomization or until death

External Links

•   Shanghai Gynecologic Oncology Group