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

  • STATUS
    Recruiting
  • End date
    Jun 22, 2023
  • participants needed
    488
  • sponsor
    Shanghai Gynecologic Oncology Group
Updated on 22 October 2021
paclitaxel
cancer
carcinoma
serum bilirubin level
metastasis
neutrophil count
carboplatin
docetaxel
cancer chemotherapy
adenocarcinoma
ovarian cancer
renal function tests
ovarian epithelial cancer
cancer antigen 125
primary peritoneal carcinoma
peritoneal carcinoma
tumor debulking
cytoreductive surgery
cytoreduction
ovarian epithelial carcinoma
serum ca-125
cancer of the ovary
debulking surgery

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.

Details
Condition Fallopian Tube Cancer, Primary Peritoneal Cancer, Ovarian Epithelial Cancer, Primary Peritoneal Carcinoma, Epithelial Ovarian Cancer, Epithelial Ovarian Carcinoma, ovarian epithelial carcinoma, carcinoma of the ovary, fallopian tube cancers
Treatment Upfront cytoreductive surgery, Interval debulking surgery
Clinical Study IdentifierNCT02859038
SponsorShanghai Gynecologic Oncology Group
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

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/L, absolute neutrophil count 1,500/L, platelets 100,000/L, 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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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