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AzTrials

Epithelial Ovarian CancerPhase 3NCT02859038

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

A Phase 3 study testing Upfront cytoreductive surgery and Interval debulking surgery in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 8 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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? Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Upfront cytoreductive surgery and Interval debulking surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
489 participants
Where
8 sitesin 2 countries
Study dates
Aug 2016to Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

China6 sites

  • Hunan Provincial Hospital

    Changsha

  • Sun Yet-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai First Maternity and Infant Hospital Affiliated to Tongji University

    Shanghai, Shanghai Municipality, 200040

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

    Shanghai, Shanghai Municipality, 200092

Other trials in China

South Korea2 sites

  • Seoul National University Hospital

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

About this study

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

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

Read the 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.

Being tested
Upfront cytoreductive surgery, Interval debulking surgery
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upfront cytoreductive surgeryProcedure or surgery

    Also called Primary debulking surgery, PDS

    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 surgeryProcedure or surgery

    Also called NACT-IDS

    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

Study groups in NCT02859038
Study groupRoleWhat they receive
Upfront cytoreductive surgeryExperimentalUpfront cytoreductive surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy.
Receives: Procedure: Upfront cytoreductive surgery
Neoadjuvant chemotherapyActive comparatorneoadjuvant 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.
Receives: Procedure: Interval debulking surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

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

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

Secondary outcomes (9)

  1. Progression-free survival

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

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

  2. Post-operative complications

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

    Measured: Participants will be followed up to 6 months after randomization

  3. Quality of life assessments

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

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

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

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

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

  9. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
489 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02859038
Sponsor's protocol ID
SGOG OV4B
Other IDs
SOC-2
Status last verified
Feb 2025
First submitted
23 Jul 2016
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32808504

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upfront cytoreductive surgery and Interval debulking surgery in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Participants will be followed for at least 5 years after randomization or until death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02859038, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.

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