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

NCT02859038 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: SGOG OV4BSOC-2
• Study Type: interventional
• Target: 489
• Locations: 2 countries
• Sites: 8

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?

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Progression-free survival

  Participants will be followed for at least 5 years after randomization or until death

• Post-operative complications

  Participants will be followed up to 6 months after randomization

• Quality of life assessments

  Participants will be followed for at least 5 years after randomization or until death

• Accumulated treatment-free survival (TFSa)

  Participants will be followed for at least 5 years after randomization or until death

• Time to first subsequent anticancer therapy (TFST)

  Participants will be followed for at least 5 years after randomization or until death

Study Arms (2)

Upfront cytoreductive surgery

EXPERIMENTAL

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

Neoadjuvant chemotherapy

ACTIVE COMPARATOR

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

Interventions

Upfront cytoreductive surgery PROCEDURE

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

Also known as: Primary debulking surgery, PDS

Upfront cytoreductive surgery

Interval debulking surgery PROCEDURE

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

Also known as: NACT-IDS

Neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≥ 18 years.
• 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.
• ECOG performance status of 0 to 2.
• ASA score of 1 to 2.
• Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
• white blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
• 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,
• serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL.
• Comply with the study protocol and follow-up.
• Written informed consent.

You may not qualify if:

• Patients with non-epithelial tumors as well as borderline tumors.
• Mucinous ovarian cancer.
• Low grade ovarian cancer.
• Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
• Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
• Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.

Sponsors & Collaborators

• Shanghai Gynecologic Oncology Group: lead

Study Sites (8)

Sun Yet-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai First Maternity and Infant Hospital Affiliated to Tongji University

Shanghai, Shanghai Municipality, 200040, China

Location

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Hunan Provincial Hospital

Changsha, China

Location

Seoul National University Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32808504 DERIVED

Related Links

• Shanghai Gynecologic Oncology Group

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Rongyu Zang, MD,PHD

  Fudan University Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2016
• First Posted: August 8, 2016
• Study Start: August 1, 2016
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

KR (2); CN (6)