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NCT Number: NCT02859038

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yet-Sen University Cancer Center, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: Primary debulking surgery, PDS

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

Other names: NACT-IDS

Primary outcomes

  1. Overall survival

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

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

Secondary outcomes

  1. Progression-free survival

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

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

  2. 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.

  3. Quality of life assessments

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

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

  4. Accumulated treatment-free survival (TFSa)

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

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

  5. Time to first subsequent anticancer therapy (TFST)

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

    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.

  6. Time to second subsequent anticancer therapy (TSST)

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

    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.

  7. The pattern of the first relapse

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

    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.

  8. The rate of 5-year progression-free survival

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

    The rate of the patients without progression or recurrence or death at 5 years.

  9. Outcomes of pulmonary embolism

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

    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.

Sponsors and collaborators

Lead sponsor

Shanghai Gynecologic Oncology Group

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Aug 8, 2016
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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