SGOG OV2 - SGOG门户网站

Clinical Trial Protocols of Shanghai Gynecologic Oncology Group --SGOG OV2/SOC-1 (2019.6 close)

Unique Protocol ID	SGOG OV2
ClinicalTrials.gov ID	ClinicalTrials.gov Identifier: NCT03983226
Version Number	V06
IRB ID	B2014-116 (4) Institutional Review Board of Zhongshan Hospital, Fudan University ec@zs-hospital.sh.cn, 021-64041990转3257
Data Monitoring Committee	Yes
Brief Title	Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)
Official Title	A Randomized Phase III Trial of Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer
Study Type	Interventional
Secondary IDs	SGOG OV2
Responsible Party	Shanghai Gynecologic Oncology Group
Sponsor	Shanghai Gynecologic Oncology Group
Collaborators	Zhongshan Hospital, Fudan University Fudan University Cancer Hospital Zhejiang Cancer Hospital Sun Yat-sen University Cancer Center
Brief Summary	The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and validate the risk model of patient selection criteria in platinum- sensitive recurrent ovarian cancer
Detailed Description	The primary objective is to determine whether secondary cytoreduction followed by chemotherapy is superior to chemotherapy alone in improving progression-free survival (PFS) and overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer
Study Start Date	July 2012
Primary Completion Date	DEC 2019 (Final data collection date for primary outcome measure)
Study Completion Date	DEC 2022 (Final data collection date for study)
Study Design	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Outcome Measures	Primary Outcome: Overall survival (Time Frame: date of randomization and date of death from any reason or last follow-up, whichever comes first, assessed until 209 events are observed or until 3 years after the last patient is randomized) Progression-free survival (Time Frame: Progression-free survival is defined as interval between date of randomization and the date of second relapse/ progression or death, whatever occurs first, assessed until 129 events are observed.) Secondary Outcome: 1.Treatment-free survival (TFS) (Time Frame: TFS is defined as the time from the date of randomization to death from any reason or last follow-up, whichever comes first, minus each treatment period after randomization, including surgery and chemotherapy (regardless of targeted therapy), assessed up to 60 months after last patient randomized) 2.Overall survival after the adjustment of one-way treatment switching (Time Frame: up to 60 months after last patient randomized.) 3.Complications incidence (Time Frame: From the operation until after 30 days) (MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications) (From the operation until after 30 days) 4.Efficiency of iMODEL to predict complete resection (operation) 5.Participants’ compliance 6.Quality of life assessments (QLQ-C30, FACT-O) The EORTC core quality of life questionnaire (QLQ-C30, version 3.0) Functional Assessment of Cancer Therapy- Ovary (FACT-O) (baseline; 6; 12; 24 and 60 months after randomization) 7.TFST (time to first subsequent anticancer therapy) (Time Frame: TFST is defined as interval between date of randomization and the first subsequent anticancer therapy, assessed up to 36 months.) 8.TSST (time to second subsequent anticancer therapy) (Time Frame: TSST is defined as interval between date of randomization and the second subsequent anticancer therapy, assessed up to 36 months.)
Conditions	Ovarian Cancer Recurrent, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Keywords	Secondary cytoreductive surgery; Ovarian Cancer; Surgery; Recurrence
Arms	1.Experimental: Secondary cytoreductive surgery (SCR followed by chemotherapy) Interventions: Intervention/treatment: Tumor debulking surgery (surgery in recurrent ovarian disease) Procedure: Maximum effort cytoreductive surgery; Drug: platinum Salvage chemotherapy 2.Active Comparator: Salvage chemotherapy (platinum-based chemotherapy) Intervention: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin----- Drug: Salvage chemotherapy
Intervention Description:	secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy; versus 6 cycles of post-operative chemotherapy
Intervention
Eligibility Criteria	Inclusion Criteria: •Age at recurrence ≥ 18 years •Patients with platinum-sensitive, first relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC, PPC, FTC), which is defined as those with platinum treatment -free interval of 6 months or more. •A complete secondary cytoreduction predicting score, iMODEL<=4.7, including FIGO stage (0 or 0.8); residual disease after primary surgery (0 or 1.5); Progression-free interval (0 or 2.4); PS ECOG (0 or 2.4); Ca125 (0 or 1.8); and ascites at recurrence (0 or 3.0). If PI and CO-PI reach consensus that the recurrent tumor detected by PET/CT could be completely resected, the index of CA125 could be scored as 0. (Revised on 09/30/2013) •Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. If single lesion outside the peritoneal cavity can be resected, MRI/CT or PET/CT scan should be performed to exclude simultaneous intra-abdominal lesions. •Patients who have given their signed and written informed consent and their consent. Exclusion Criteria: •Patients with borderline tumors as well as non-epithelial tumors. •Patients for interval-debulking, or for second-look surgery, or palliative surgery planned. •Impossible to assess the resectability or evaluate the score. Radiological signs suggesting complete resection is impossible. •More than one prior chemotherapy. •Second relapse or more •Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected. •Progression during chemotherapy or recurrence within 6 months after first-line platinum based therapy •Any contradiction not allowing surgery and/or chemotherapy oAccompanied by hypoxia serious chronic obstructive pulmonary disease oUncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine. oSevere hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency oActive ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy. oUncontrolled diabetes oUncontrolled epilepsy need long-term antiepileptic treatment. •Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents, or bevacizumab)
Gender	Female
Minimum Age	18 Years
Maximum Age	80 Years
Accepts Healthy Volunteers	No
Sample size	356
Central Contact	Tingyan Shi, MD, PhD. +862164041990. shi.tingyan@zs-hospital.sh.cn Yuting Luan, RN. +862164041990. yutingluan@163.com
Principal Investigators	Rongyu Zang, MD, PhD Tel: +862164041990.
Locations	China
Co-Principal Investigator	Jianqing Zhu, MD Xiao Huang, MD,PhD
Recruitment Status	Active, recruiting complete